Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

A Weight Loss Study in Overweight Men and Women

This study has been terminated.
(Clinical trial terminated due to results from recent nonclinical studies)
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00993421
First received: October 9, 2009
Last updated: June 2, 2011
Last verified: June 2011
History of Changes
Results First Received: May 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Obesity
Interventions: Drug: LY377604
Drug: Sibutramine
Drug: Metoprolol
Drug: Placebo sibutramine
Drug: Placebo Metoprolol
Drug: Placebo LY377604

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

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.
LY377604 (75 mg) Given orally, daily for 24 weeks.
Sibutramine (30 mg)/Metoprolol (200 mg)

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)/Sibutramine (30 mg)

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)/Sibutramine (30 mg)

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)/Sibutramine (30 mg)

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)/Sibutramine (15 mg)

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.

Participant Flow:   Overall Study
    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)  
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  
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  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

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.
LY377604 (75 mg) Given orally, daily for 24 weeks.
Sibutramine (30 mg)/Metoprolol (200 mg)

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)/Sibutramine (30 mg)

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)/Sibutramine (30 mg)

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)/Sibutramine (30 mg)

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)/Sibutramine (15 mg)

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 Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
 		  49     49     48     49     52     50     46     343  
Age  
[units: years]
Mean (Standard Deviation) 		  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)  
Gender  
[units: participants]
 		               
Female     41     42     38     39     40     41     34     275  
Male     8     7     10     10     12     9     12     68  
Race (NIH/OMB)  
[units: participants]
 		               
American Indian or Alaska Native     0     0     0     1     0     1     0     2  
Asian     0     0     0     0     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     1     0     0     1     2  
Black or African American     12     5     8     10     8     6     7     56  
White     36     43     39     34     43     42     36     273  
More than one race     1     1     1     3     1     1     2     10  
Unknown or Not Reported     0     0     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
 		               
United States     49     49     48     49     52     50     46     343  
Height  
[units: centimeters (cm)]
Mean (Standard Deviation) 		  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  
[units: kilograms (kg)]
Mean (Standard Deviation) 		  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]
[units: kilograms/square meters (kg/m^2)]
Mean (Standard Deviation) 		  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)  
Blood Pressure  
[units: mm Hg]
Mean (Standard Deviation) 		               
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  
[units: centimeters (cm)]
Mean (Standard Deviation) 		               
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] Body mass index is an estimate of body fat based on body weight (kilograms) divided by height (meters) squared.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Body Weight From Baseline to 24 Week Endpoint   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 1

2.  Secondary:   The Mean Change in Body Weight From Baseline to 24 Week Endpoint   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants Who Achieve a Minimum of 10% Weight Loss From Baseline at 24 Weeks   [ Time Frame: 24 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Change in Heart Rate From Baseline to 24 Week Endpoint   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Change in Blood Pressure From Baseline to 24 Week Endpoint   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Change in Body Composition Using Dual Energy X-ray Absorptiometry (DXA) From Baseline to 24 Week Endpoint   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Change in Waist Circumference From Baseline to 24 Week Endpoint   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Percentage Change in Waist Circumference From Baseline to 24 Week Endpoint   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Change in Total Cholesterol From Baseline to 24 Weeks Endpoint   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to 24 Weeks Endpoint   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to 24 Weeks Endpoint   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Change in Triglycerides From Baseline to 24 Weeks Endpoint   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 12

13.  Secondary:   Change From Baseline for Obesity Weight Loss Quality of Life Instrument (OWL-QoL)   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 13

14.  Secondary:   Change From Baseline in Vitality Scale of Medical Outcomes Short Form - 36 (SF-36) Scale   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 14

15.  Secondary:   Change in Glycated Hemoglobin A1c (HbA1c) From Baseline   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 15

16.  Secondary:   Change in Fasting Glucose From Baseline to 24 Weeks Endpoint   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 16

17.  Secondary:   Change in Fasting Insulin From Baseline to 24 Weeks Endpoint   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 17

18.  Secondary:   Change in Insulin Resistance From Baseline to 24 Weeks Endpoint   [ Time Frame: Baseline, 24 weeks ]
  Show Outcome Measure 18

19.  Secondary:   Pharmacokinetics: Area Under the Concentration Time Curve (AUC)   [ Time Frame: 4 weeks, 12 weeks, and 24 weeks ]
  Show Outcome Measure 19

20.  Secondary:   Pharmacokinetics: Maximum Concentration (Cmax)   [ Time Frame: 4 weeks, 12 weeks, and 24 weeks ]
  Show Outcome Measure 20


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00993421     History of Changes
Other Study ID Numbers: 11892
I1L-MC-GAEB ( Other Identifier: Eli Lilly and Company )
Study First Received: October 9, 2009
Results First Received: May 11, 2011
Last Updated: June 2, 2011
Health Authority: United States: Food and Drug Administration