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A Weight Loss Study in Overweight Men and Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00993421
Recruitment Status : Terminated (Clinical trial terminated due to results from recent nonclinical studies)
First Posted : October 12, 2009
Results First Posted : June 2, 2011
Last Update Posted : June 3, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Obesity
Interventions Drug: LY377604
Drug: Sibutramine
Drug: Metoprolol
Drug: Placebo sibutramine
Drug: Placebo Metoprolol
Drug: Placebo LY377604
Enrollment 343
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Period Title: Overall Study
Started 49 49 48 49 52 50 46
Completed 5 4 5 4 6 4 4
Not Completed 44 45 43 45 46 46 42
Reason Not Completed
Adverse Event             2             7             6             9             5             7             1
Sponsor Decision             36             31             28             30             38             30             29
Lost to Follow-up             3             5             5             0             0             0             6
Withdrawal by Subject             3             2             3             3             3             5             3
Death             0             0             0             0             0             0             1
Entry Criteria Exclusion             0             0             1             3             0             1             0
Physician Decision             0             0             0             0             0             1             1
Protocol Violation             0             0             0             0             0             2             1
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg) Total
Hide Arm/Group Description

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Total of all reporting groups
Overall Number of Baseline Participants 49 49 48 49 52 50 46 343
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 49 participants 48 participants 49 participants 52 participants 50 participants 46 participants 343 participants
42.71  (10.86) 43.89  (11.02) 44.68  (12.00) 43.42  (11.06) 44.15  (10.71) 45.80  (9.15) 43.93  (10.15) 44.09  (10.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 48 participants 49 participants 52 participants 50 participants 46 participants 343 participants
Female
41
  83.7%
42
  85.7%
38
  79.2%
39
  79.6%
40
  76.9%
41
  82.0%
34
  73.9%
275
  80.2%
Male
8
  16.3%
7
  14.3%
10
  20.8%
10
  20.4%
12
  23.1%
9
  18.0%
12
  26.1%
68
  19.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 48 participants 49 participants 52 participants 50 participants 46 participants 343 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
1
   2.0%
0
   0.0%
2
   0.6%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
1
   2.2%
2
   0.6%
Black or African American
12
  24.5%
5
  10.2%
8
  16.7%
10
  20.4%
8
  15.4%
6
  12.0%
7
  15.2%
56
  16.3%
White
36
  73.5%
43
  87.8%
39
  81.3%
34
  69.4%
43
  82.7%
42
  84.0%
36
  78.3%
273
  79.6%
More than one race
1
   2.0%
1
   2.0%
1
   2.1%
3
   6.1%
1
   1.9%
1
   2.0%
2
   4.3%
10
   2.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants 49 participants 48 participants 49 participants 52 participants 50 participants 46 participants 343 participants
49 49 48 49 52 50 46 343
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 49 participants 49 participants 48 participants 49 participants 52 participants 50 participants 46 participants 343 participants
166.10  (8.02) 166.86  (8.40) 167.51  (9.22) 165.23  (8.93) 168.13  (7.88) 168.99  (8.18) 168.38  (7.50) 167.32  (8.34)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 49 participants 49 participants 48 participants 49 participants 52 participants 50 participants 46 participants 343 participants
97.92  (18.73) 97.15  (15.67) 102.25  (17.80) 96.36  (18.08) 99.09  (17.73) 100.96  (17.20) 100.09  (17.11) 99.10  (17.46)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms/square meters (kg/m^2)
Number Analyzed 49 participants 49 participants 48 participants 49 participants 52 participants 50 participants 46 participants 343 participants
35.22  (4.96) 34.78  (4.53) 36.34  (5.36) 35.12  (4.55) 34.86  (4.39) 35.30  (4.44) 35.22  (4.87) 35.26  (4.71)
[1]
Measure Description: Body mass index is an estimate of body fat based on body weight (kilograms) divided by height (meters) squared.
Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 49 participants 49 participants 48 participants 49 participants 52 participants 50 participants 46 participants 343 participants
Systolic Blood Pressure (SBP) 117.11  (11.53) 115.72  (10.78) 117.35  (10.13) 118.67  (11.11) 118.34  (11.37) 119.86  (11.42) 120.72  (11.36) 118.24  (11.13)
Diastolic Blood Pressure (DBP) 75.12  (7.31) 74.40  (7.70) 75.83  (6.76) 76.61  (7.07) 76.94  (6.31) 77.87  (6.82) 78.38  (6.23) 76.44  (6.97)
Waist and Hip Circumference  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 49 participants 49 participants 48 participants 49 participants 52 participants 50 participants 46 participants 343 participants
Waist Circumference 109.13  (14.10) 107.42  (10.70) 111.47  (12.58) 107.31  (12.06) 110.18  (10.80) 109.99  (11.49) 109.15  (12.95) 109.24  (12.10)
Hip Circumference 119.76  (12.36) 118.55  (9.42) 120.29  (11.51) 117.65  (11.13) 117.30  (14.96) 119.43  (11.45) 118.01  (11.43) 118.70  (11.83)
1.Primary Outcome
Title Percent Change in Body Weight From Baseline to 24 Week Endpoint
Hide Description Body weight percentage change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body weight, age, gender were used as covariates.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 28 26 24 25 32 22 23
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-2.21  (0.81) 0.48  (0.84) -6.12  (0.86) -8.53  (0.80) -6.61  (0.79) -7.05  (0.85) -4.71  (0.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY377604 (75 mg), LY377604 (15 mg)/Sibutramine (30 mg)
Comments Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY377604 (75 mg), LY377604 (40 mg)/Sibutramine (30 mg)
Comments Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY377604 (75 mg), LY377604 (75 mg)/Sibutramine (30 mg)
Comments Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY377604 (75 mg), LY377604 (75 mg)/Sibutramine (15 mg)
Comments Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Sibutramine (30 mg)/Metoprolol (200 mg), LY377604 (15 mg)/Sibutramine (30 mg)
Comments Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Sibutramine (30 mg)/Metoprolol (200 mg), LY377604 (40 mg)/Sibutramine (30 mg)
Comments Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.668
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Sibutramine (30 mg)/Metoprolol (200 mg), LY377604 (75 mg)/Sibutramine (30 mg)
Comments Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.437
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Sibutramine (30 mg)/Metoprolol (200 mg), LY377604 (75 mg)/Sibutramine (15 mg)
Comments Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.249
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title The Mean Change in Body Weight From Baseline to 24 Week Endpoint
Hide Description Body weight change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body weight, age, gender were used as covariates.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 28 26 24 25 32 22 23
Least Squares Mean (Standard Error)
Unit of Measure: kilograms
-2.37  (0.82) 0.45  (0.85) -6.41  (0.87) -8.15  (0.81) -6.49  (0.79) -7.06  (0.85) -4.68  (0.87)
3.Secondary Outcome
Title Percentage of Participants Who Achieve a Minimum of 10% Weight Loss From Baseline at 24 Weeks
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 49 49 48 49 52 50 46
Measure Type: Number
Unit of Measure: percentage of participants
10.2 0.0 18.8 34.7 21.2 18.0 6.5
4.Secondary Outcome
Title Change in Heart Rate From Baseline to 24 Week Endpoint
Hide Description Heart rate change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline heart rate, age, gender were used as covariates.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 30 27 24 26 33 22 25
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute (bpm)
-0.69  (1.51) -3.34  (1.60) -1.37  (1.67) 6.11  (1.60) 2.19  (1.44) -2.66  (1.72) -2.46  (1.63)
5.Secondary Outcome
Title Change in Blood Pressure From Baseline to 24 Week Endpoint
Hide Description Blood pressure change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline blood pressure, age, gender were used as covariates.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 30 27 24 26 33 22 25
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
Systolic Blood Pressure -2.84  (1.67) -3.59  (1.75) -3.77  (1.84) 3.25  (1.76) -1.17  (1.59) -0.43  (1.90) 0.95  (1.80)
Diastolic Blood Pressure -2.25  (1.28) -3.84  (1.35) -2.51  (1.41) 2.03  (1.34) 0.13  (1.22) -2.87  (1.45) -0.38  (1.38)
6.Secondary Outcome
Title Change in Body Composition Using Dual Energy X-ray Absorptiometry (DXA) From Baseline to 24 Week Endpoint
Hide Description Change in body composition (lean body mass and fat mass) was assessed using dual energy x-ray absorptiometry (DXA) and is presented as LSMEAN values with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body composition, age, gender were used as covariates.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 28 23 23 23 31 21 25
Least Squares Mean (Standard Error)
Unit of Measure: kilograms (kg)
Fat Mass -2.40  (0.72) 0.54  (0.76) -3.00  (0.75) -6.13  (0.71) -4.80  (0.67) -4.29  (0.77) -2.55  (0.73)
Lean Mass -0.55  (0.41) 0.15  (0.45) -1.92  (0.45) -1.85  (0.43) -0.71  (0.39) -1.08  (0.47) -1.48  (0.43)
7.Secondary Outcome
Title Change in Waist Circumference From Baseline to 24 Week Endpoint
Hide Description Change from baseline to endpoint is presented as LSMEAN with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline waist circumference, age, gender were used as covariates.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 31 27 24 25 32 22 25
Least Squares Mean (Standard Error)
Unit of Measure: centimeter (cm)
-6.58  (2.44) -2.51  (2.62) -8.84  (2.77) -6.76  (2.71) -3.57  (2.38) -3.55  (2.88) -8.67  (2.68)
8.Secondary Outcome
Title Percentage Change in Waist Circumference From Baseline to 24 Week Endpoint
Hide Description Percentage change from baseline to endpoint is presented as LSMEAN with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline waist circumference, age, gender were used as covariates.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 31 27 24 25 32 22 25
Least Squares Mean (Standard Deviation)
Unit of Measure: percent change
-5.86  (2.21) -2.22  (2.38) -7.55  (2.52) -5.96  (2.46) -3.02  (2.16) -3.11  (2.62) -7.29  (2.44)
9.Secondary Outcome
Title Change in Total Cholesterol From Baseline to 24 Weeks Endpoint
Hide Description [Not Specified]
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 48 49 45 49 48 50 43
Mean (Standard Deviation)
Unit of Measure: millimole/Liter (mmol/L)
-0.12  (0.68) -0.13  (0.47) -0.04  (0.69) -0.01  (0.67) 0.00  (0.68) 0.17  (0.70) -0.13  (0.76)
10.Secondary Outcome
Title Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to 24 Weeks Endpoint
Hide Description [Not Specified]
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 48 49 45 49 48 50 43
Mean (Standard Deviation)
Unit of Measure: millimole/Liter (mmol/L)
-0.02  (0.16) -0.05  (0.19) -0.03  (0.15) 0.01  (0.15) 0.06  (0.21) 0.01  (0.17) -0.04  (0.17)
11.Secondary Outcome
Title Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to 24 Weeks Endpoint
Hide Description [Not Specified]
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 48 49 45 49 48 49 43
Mean (Standard Deviation)
Unit of Measure: millimole/Liter (mmol/L)
-0.07  (0.57) -0.03  (0.44) 0.00  (0.62) -0.00  (0.58) -0.07  (0.50) 0.16  (0.65) -0.16  (0.67)
12.Secondary Outcome
Title Change in Triglycerides From Baseline to 24 Weeks Endpoint
Hide Description [Not Specified]
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 48 49 45 49 48 50 43
Mean (Standard Deviation)
Unit of Measure: millimole/Liter (mmol/L)
-0.06  (0.61) -0.11  (0.48) -0.04  (0.66) 0.04  (0.60) 0.04  (0.55) 0.03  (0.72) 0.22  (0.94)
13.Secondary Outcome
Title Change From Baseline for Obesity Weight Loss Quality of Life Instrument (OWL-QoL)
Hide Description Results presented as Least Squares Mean with treatment, visit, and their interaction as fixed effects, subject as random effect, baseline body mass index used as covariate. OWL-QoL consists of 17 items on scale ranging from 0 (Not at all) to 6 (A very great deal). Before calculating scores, each item is reversed. A single quality of life score is computed by summing each item and transforming this raw score onto standardized scale of 0 (greatest impact) to 100 (lowest impact) using formula: score = [(sum of component items score (minus) lowest possible score/ possible raw score range)*100].
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 31 26 24 26 34 23 26
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
11.71  (4.93) 2.67  (5.30) 13.96  (5.26) 16.52  (5.27) 17.44  (5.17) 13.53  (5.35) 14.02  (5.23)
14.Secondary Outcome
Title Change From Baseline in Vitality Scale of Medical Outcomes Short Form - 36 (SF-36) Scale
Hide Description Vitality change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body mass index was used as covariate. SF-36 is a self-reported questionnaire that consists of 36 questions covering 8 health domains including vitality. The vitality domain results are presented. The vitality domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 31 27 24 25 34 24 26
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
10.79  (5.24) 5.83  (5.66) 16.81  (5.63) 10.69  (5.69) 7.35  (5.53) 10.62  (5.72) 13.61  (5.58)
15.Secondary Outcome
Title Change in Glycated Hemoglobin A1c (HbA1c) From Baseline
Hide Description Analysis of change in HbA1c was not conducted due to an inadequate number of samples.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to the small sample size.
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Change in Fasting Glucose From Baseline to 24 Weeks Endpoint
Hide Description Analysis of change in fasting glucose was not conducted due to an inadequate number of samples.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to an inadequate number of samples.
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Change in Fasting Insulin From Baseline to 24 Weeks Endpoint
Hide Description Analysis of change in fasting insulin was not conducted due to an inadequate number of samples.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to an inadequate number of samples.
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Change in Insulin Resistance From Baseline to 24 Weeks Endpoint
Hide Description Analysis of change in insulin resistance was not conducted due to an inadequate number of samples.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to inadequate number of samples.
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration Time Curve (AUC)
Hide Description Analysis of AUC was not conducted due to an inadequate number of samples collected.
Time Frame 4 weeks, 12 weeks, and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed because of the low sample size.
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Pharmacokinetics: Maximum Concentration (Cmax)
Hide Description Analysis of Cmax was not conducted due to an inadequate number of samples collected.
Time Frame 4 weeks, 12 weeks, and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to the small sample size.
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30 mg)/Metoprolol (200 mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description:

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Overall Number of Participants Analyzed 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo LY377604 (75 mg) Sibutramine (30mg)/Metoprolol (200mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Hide Arm/Group Description

Placebo LY377604: given orally, daily for 24 weeks.

Placebo sibutramine: given orally, daily for 24 weeks.

Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.

Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by 2 week taper (1 week at 100 mg/day followed by 1 week at 50 mg/day).

Placebo LY377604: given orally, daily for 24 weeks.

LY377604 (15 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (40 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (30 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

LY377604 (75 mg): Given orally, daily for 24 weeks.

sibutramine (15 mg): Given orally, daily for 24 weeks.

Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

All-Cause Mortality
Placebo LY377604 (75 mg) Sibutramine (30mg)/Metoprolol (200mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo LY377604 (75 mg) Sibutramine (30mg)/Metoprolol (200mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/49 (0.00%)      0/49 (0.00%)      2/48 (4.17%)      2/49 (4.08%)      0/52 (0.00%)      1/50 (2.00%)      2/46 (4.35%)    
Gastrointestinal disorders               
Haemorrhoids  1  0/49 (0.00%)  0 0/49 (0.00%)  0 1/48 (2.08%)  1 0/49 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0
Vomiting  1  0/49 (0.00%)  0 0/49 (0.00%)  0 0/48 (0.00%)  0 1/49 (2.04%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0
Hepatobiliary disorders               
Cholecystitis  1  0/49 (0.00%)  0 0/49 (0.00%)  0 0/48 (0.00%)  0 1/49 (2.04%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0
Infections and infestations               
Meningitis viral  1  0/49 (0.00%)  0 0/49 (0.00%)  0 1/48 (2.08%)  1 0/49 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0
Injury, poisoning and procedural complications               
Head injury  1 [1]  0/49 (0.00%)  0 0/49 (0.00%)  0 0/48 (0.00%)  0 0/49 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1
Investigations               
Blood pressure decreased  1  0/49 (0.00%)  0 0/49 (0.00%)  0 0/48 (0.00%)  0 0/49 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1
Nervous system disorders               
Paraesthesia  1  0/49 (0.00%)  0 0/49 (0.00%)  0 0/48 (0.00%)  0 1/49 (2.04%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Pulmonary embolism  1  0/49 (0.00%)  0 0/49 (0.00%)  0 0/48 (0.00%)  0 0/49 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/46 (0.00%)  0
Skin and subcutaneous tissue disorders               
Hypoaesthesia facial  1  0/49 (0.00%)  0 0/49 (0.00%)  0 0/48 (0.00%)  0 1/49 (2.04%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0
Vascular disorders               
Deep vein thrombosis  1  0/49 (0.00%)  0 0/49 (0.00%)  0 0/48 (0.00%)  0 0/49 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/46 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
[1]
This event (result of automobile accident) resulted in death.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo LY377604 (75 mg) Sibutramine (30mg)/Metoprolol (200mg) LY377604 (15 mg)/Sibutramine (30 mg) LY377604 (40 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (30 mg) LY377604 (75 mg)/Sibutramine (15 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/49 (83.67%)      39/49 (79.59%)      38/48 (79.17%)      44/49 (89.80%)      43/52 (82.69%)      46/50 (92.00%)      33/46 (71.74%)    
Eye disorders               
Vision blurred  1  0/49 (0.00%)  0 1/49 (2.04%)  1 1/48 (2.08%)  1 0/49 (0.00%)  0 1/52 (1.92%)  1 0/50 (0.00%)  0 3/46 (6.52%)  3
Gastrointestinal disorders               
Abdominal discomfort  1  2/49 (4.08%)  2 2/49 (4.08%)  2 0/48 (0.00%)  0 2/49 (4.08%)  2 3/52 (5.77%)  4 0/50 (0.00%)  0 1/46 (2.17%)  1
Constipation  1  4/49 (8.16%)  4 2/49 (4.08%)  2 11/48 (22.92%)  11 9/49 (18.37%)  9 7/52 (13.46%)  8 5/50 (10.00%)  5 2/46 (4.35%)  2
Diarrhoea  1  2/49 (4.08%)  2 3/49 (6.12%)  3 1/48 (2.08%)  1 3/49 (6.12%)  3 3/52 (5.77%)  3 5/50 (10.00%)  6 2/46 (4.35%)  2
Dry mouth  1  1/49 (2.04%)  1 4/49 (8.16%)  4 6/48 (12.50%)  6 20/49 (40.82%)  20 16/52 (30.77%)  16 10/50 (20.00%)  12 8/46 (17.39%)  9
Nausea  1  3/49 (6.12%)  5 0/49 (0.00%)  0 3/48 (6.25%)  3 4/49 (8.16%)  5 2/52 (3.85%)  2 3/50 (6.00%)  3 2/46 (4.35%)  4
Vomiting  1  5/49 (10.20%)  5 0/49 (0.00%)  0 1/48 (2.08%)  1 2/49 (4.08%)  2 1/52 (1.92%)  1 1/50 (2.00%)  1 0/46 (0.00%)  0
General disorders               
Asthenia  1  1/49 (2.04%)  1 0/49 (0.00%)  0 1/48 (2.08%)  1 3/49 (6.12%)  3 2/52 (3.85%)  2 2/50 (4.00%)  2 0/46 (0.00%)  0
Fatigue  1  2/49 (4.08%)  2 5/49 (10.20%)  5 2/48 (4.17%)  2 1/49 (2.04%)  1 5/52 (9.62%)  5 1/50 (2.00%)  1 4/46 (8.70%)  4
Infections and infestations               
Nasopharyngitis  1  5/49 (10.20%)  5 5/49 (10.20%)  5 2/48 (4.17%)  2 2/49 (4.08%)  2 1/52 (1.92%)  1 4/50 (8.00%)  4 2/46 (4.35%)  2
Sinusitis  1  2/49 (4.08%)  3 2/49 (4.08%)  2 2/48 (4.17%)  2 2/49 (4.08%)  2 3/52 (5.77%)  3 0/50 (0.00%)  0 0/46 (0.00%)  0
Upper respiratory tract infection  1  5/49 (10.20%)  5 6/49 (12.24%)  9 4/48 (8.33%)  4 2/49 (4.08%)  2 4/52 (7.69%)  4 4/50 (8.00%)  4 5/46 (10.87%)  7
Urinary tract infection  1  3/49 (6.12%)  3 2/49 (4.08%)  2 3/48 (6.25%)  3 3/49 (6.12%)  3 0/52 (0.00%)  0 4/50 (8.00%)  4 4/46 (8.70%)  4
Viral infection  1  1/49 (2.04%)  1 1/49 (2.04%)  2 1/48 (2.08%)  1 5/49 (10.20%)  6 2/52 (3.85%)  3 0/50 (0.00%)  0 2/46 (4.35%)  2
Injury, poisoning and procedural complications               
Muscle strain  1  0/49 (0.00%)  0 0/49 (0.00%)  0 0/48 (0.00%)  0 3/49 (6.12%)  3 3/52 (5.77%)  3 0/50 (0.00%)  0 2/46 (4.35%)  2
Investigations               
Blood creatine phosphokinase increased  1  2/49 (4.08%)  2 1/49 (2.04%)  1 0/48 (0.00%)  0 3/49 (6.12%)  3 0/52 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0
Metabolism and nutrition disorders               
Decreased appetite  1  1/49 (2.04%)  1 1/49 (2.04%)  1 1/48 (2.08%)  1 2/49 (4.08%)  2 4/52 (7.69%)  4 2/50 (4.00%)  2 1/46 (2.17%)  1
Increased appetite  1  1/49 (2.04%)  1 3/49 (6.12%)  3 0/48 (0.00%)  0 0/49 (0.00%)  0 0/52 (0.00%)  0 1/50 (2.00%)  1 0/46 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Arthralgia  1  1/49 (2.04%)  1 4/49 (8.16%)  4 3/48 (6.25%)  3 3/49 (6.12%)  3 1/52 (1.92%)  1 3/50 (6.00%)  4 0/46 (0.00%)  0
Back pain  1  1/49 (2.04%)  1 0/49 (0.00%)  0 3/48 (6.25%)  3 4/49 (8.16%)  4 2/52 (3.85%)  2 1/50 (2.00%)  1 0/46 (0.00%)  0
Pain in extremity  1  4/49 (8.16%)  4 1/49 (2.04%)  1 1/48 (2.08%)  1 0/49 (0.00%)  0 1/52 (1.92%)  1 1/50 (2.00%)  1 2/46 (4.35%)  2
Nervous system disorders               
Dizziness  1  2/49 (4.08%)  2 3/49 (6.12%)  3 4/48 (8.33%)  4 4/49 (8.16%)  4 7/52 (13.46%)  8 6/50 (12.00%)  6 1/46 (2.17%)  1
Dysgeusia  1  0/49 (0.00%)  0 1/49 (2.04%)  1 1/48 (2.08%)  1 1/49 (2.04%)  1 1/52 (1.92%)  1 3/50 (6.00%)  3 0/46 (0.00%)  0
Headache  1  4/49 (8.16%)  4 3/49 (6.12%)  3 5/48 (10.42%)  5 5/49 (10.20%)  5 5/52 (9.62%)  6 4/50 (8.00%)  4 2/46 (4.35%)  2
Hypoaesthesia  1  2/49 (4.08%)  3 3/49 (6.12%)  5 0/48 (0.00%)  0 1/49 (2.04%)  1 2/52 (3.85%)  2 0/50 (0.00%)  0 1/46 (2.17%)  1
Migraine  1  0/49 (0.00%)  0 3/49 (6.12%)  3 1/48 (2.08%)  1 1/49 (2.04%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0
Sinus headache  1  0/49 (0.00%)  0 0/49 (0.00%)  0 0/48 (0.00%)  0 1/49 (2.04%)  1 0/52 (0.00%)  0 3/50 (6.00%)  3 0/46 (0.00%)  0
Psychiatric disorders               
Anxiety  1  2/49 (4.08%)  3 0/49 (0.00%)  0 2/48 (4.17%)  2 1/49 (2.04%)  1 4/52 (7.69%)  4 0/50 (0.00%)  0 0/46 (0.00%)  0
Insomnia  1  2/49 (4.08%)  2 5/49 (10.20%)  5 3/48 (6.25%)  3 8/49 (16.33%)  8 7/52 (13.46%)  7 6/50 (12.00%)  6 2/46 (4.35%)  2
Stress  1  0/49 (0.00%)  0 0/49 (0.00%)  0 0/48 (0.00%)  0 0/49 (0.00%)  0 3/52 (5.77%)  3 0/50 (0.00%)  0 0/46 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Cough  1  2/49 (4.08%)  2 2/49 (4.08%)  2 1/48 (2.08%)  1 4/49 (8.16%)  4 1/52 (1.92%)  1 1/50 (2.00%)  1 1/46 (2.17%)  1
Dyspnoea  1  0/49 (0.00%)  0 1/49 (2.04%)  1 0/48 (0.00%)  0 3/49 (6.12%)  3 0/52 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1
Oropharyngeal pain  1  0/49 (0.00%)  0 0/49 (0.00%)  0 1/48 (2.08%)  1 5/49 (10.20%)  5 3/52 (5.77%)  4 2/50 (4.00%)  2 1/46 (2.17%)  2
Sinus congestion  1  1/49 (2.04%)  1 1/49 (2.04%)  1 0/48 (0.00%)  0 3/49 (6.12%)  3 1/52 (1.92%)  1 2/50 (4.00%)  2 1/46 (2.17%)  1
Skin and subcutaneous tissue disorders               
Hyperhidrosis  1  0/49 (0.00%)  0 0/49 (0.00%)  0 0/48 (0.00%)  0 1/49 (2.04%)  1 2/52 (3.85%)  2 3/50 (6.00%)  3 0/46 (0.00%)  0
Rash  1  0/49 (0.00%)  0 0/49 (0.00%)  0 1/48 (2.08%)  1 2/49 (4.08%)  2 4/52 (7.69%)  4 1/50 (2.00%)  1 1/46 (2.17%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00993421    
Other Study ID Numbers: 11892
I1L-MC-GAEB ( Other Identifier: Eli Lilly and Company )
First Submitted: October 9, 2009
First Posted: October 12, 2009
Results First Submitted: May 11, 2011
Results First Posted: June 2, 2011
Last Update Posted: June 3, 2011