A Weight Loss Study in Overweight Men and Women

• ClinicalTrials.gov Identifier: NCT00993421
• Recruitment Status: Terminated
• First Posted: October 12, 2009
• Results First Posted: June 2, 2011
• Last Update Posted: June 3, 2011
• Sponsor: Eli Lilly and Company
• 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

Participant Flow

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)
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

Baseline Characteristics

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
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
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)

Outcome Measures

1. Primary Outcome

Title	Percent Change in Body Weight From Baseline to 24 Week Endpoint
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

Outcome Measure Data

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)
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)

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]

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]

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]

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]

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]

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]

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]

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
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

Outcome Measure Data

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)
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
Description	[Not Specified]
Time Frame	24 weeks

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
Description	[Not Specified]
Time Frame	Baseline, 24 weeks

Outcome Measure Data

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)
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
Description	[Not Specified]
Time Frame	Baseline, 24 weeks

Outcome Measure Data

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)
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
Description	[Not Specified]
Time Frame	Baseline, 24 weeks

Outcome Measure Data

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)
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
Description	[Not Specified]
Time Frame	Baseline, 24 weeks

Outcome Measure Data

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)
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)
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
Description	Analysis of change in HbA1c was not conducted due to an inadequate number of samples.
Time Frame	Baseline, 24 weeks

Outcome Measure Data

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)
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
Description	Analysis of change in fasting glucose was not conducted due to an inadequate number of samples.
Time Frame	Baseline, 24 weeks

Outcome Measure Data

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)
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
Description	Analysis of change in fasting insulin was not conducted due to an inadequate number of samples.
Time Frame	Baseline, 24 weeks

Outcome Measure Data

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)
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
Description	Analysis of change in insulin resistance was not conducted due to an inadequate number of samples.
Time Frame	Baseline, 24 weeks

Outcome Measure Data

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)
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)
Description	Analysis of AUC was not conducted due to an inadequate number of samples collected.
Time Frame	4 weeks, 12 weeks, and 24 weeks

Outcome Measure Data

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)
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)
Description	Analysis of Cmax was not conducted due to an inadequate number of samples collected.
Time Frame	4 weeks, 12 weeks, and 24 weeks

Outcome Measure Data

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)
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.

Adverse Events

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)

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

--/--

--/--

--/--

--/--

--/--

--/--

--/--

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.

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

Limitations and Caveats

[Not Specified]

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.

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
• 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