Trial Outcomes & Findings for A Weight Loss Study in Overweight Men and Women (NCT NCT00993421)
NCT ID: NCT00993421
Last Updated: 2011-06-03
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
343 participants
Primary outcome timeframe
Baseline, 24 weeks
Results posted on
2011-06-03
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
48
|
49
|
52
|
50
|
46
|
|
Overall Study
COMPLETED
|
5
|
4
|
5
|
4
|
6
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
44
|
45
|
43
|
45
|
46
|
46
|
42
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
7
|
6
|
9
|
5
|
7
|
1
|
|
Overall Study
Sponsor Decision
|
36
|
31
|
28
|
30
|
38
|
30
|
29
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
5
|
0
|
0
|
0
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
3
|
3
|
3
|
5
|
3
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Entry Criteria Exclusion
|
0
|
0
|
1
|
3
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
Baseline Characteristics
A Weight Loss Study in Overweight Men and Women
Baseline characteristics by cohort
| Measure |
Placebo
n=49 Participants
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)
n=49 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=48 Participants
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)
n=49 Participants
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)
n=52 Participants
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)
n=50 Participants
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)
n=46 Participants
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
n=343 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age Continuous
|
42.71 years
STANDARD_DEVIATION 10.86 • n=5 Participants
|
43.89 years
STANDARD_DEVIATION 11.02 • n=7 Participants
|
44.68 years
STANDARD_DEVIATION 12.00 • n=5 Participants
|
43.42 years
STANDARD_DEVIATION 11.06 • n=4 Participants
|
44.15 years
STANDARD_DEVIATION 10.71 • n=21 Participants
|
45.80 years
STANDARD_DEVIATION 9.15 • n=10 Participants
|
43.93 years
STANDARD_DEVIATION 10.15 • n=115 Participants
|
44.09 years
STANDARD_DEVIATION 10.68 • n=24 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
34 Participants
n=115 Participants
|
275 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
68 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
56 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
42 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
273 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
49 participants
n=7 Participants
|
48 participants
n=5 Participants
|
49 participants
n=4 Participants
|
52 participants
n=21 Participants
|
50 participants
n=10 Participants
|
46 participants
n=115 Participants
|
343 participants
n=24 Participants
|
|
Height
|
166.10 centimeters (cm)
STANDARD_DEVIATION 8.02 • n=5 Participants
|
166.86 centimeters (cm)
STANDARD_DEVIATION 8.40 • n=7 Participants
|
167.51 centimeters (cm)
STANDARD_DEVIATION 9.22 • n=5 Participants
|
165.23 centimeters (cm)
STANDARD_DEVIATION 8.93 • n=4 Participants
|
168.13 centimeters (cm)
STANDARD_DEVIATION 7.88 • n=21 Participants
|
168.99 centimeters (cm)
STANDARD_DEVIATION 8.18 • n=10 Participants
|
168.38 centimeters (cm)
STANDARD_DEVIATION 7.50 • n=115 Participants
|
167.32 centimeters (cm)
STANDARD_DEVIATION 8.34 • n=24 Participants
|
|
Weight
|
97.92 kilograms (kg)
STANDARD_DEVIATION 18.73 • n=5 Participants
|
97.15 kilograms (kg)
STANDARD_DEVIATION 15.67 • n=7 Participants
|
102.25 kilograms (kg)
STANDARD_DEVIATION 17.80 • n=5 Participants
|
96.36 kilograms (kg)
STANDARD_DEVIATION 18.08 • n=4 Participants
|
99.09 kilograms (kg)
STANDARD_DEVIATION 17.73 • n=21 Participants
|
100.96 kilograms (kg)
STANDARD_DEVIATION 17.20 • n=10 Participants
|
100.09 kilograms (kg)
STANDARD_DEVIATION 17.11 • n=115 Participants
|
99.10 kilograms (kg)
STANDARD_DEVIATION 17.46 • n=24 Participants
|
|
Body Mass Index (BMI)
|
35.22 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.96 • n=5 Participants
|
34.78 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.53 • n=7 Participants
|
36.34 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 5.36 • n=5 Participants
|
35.12 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.55 • n=4 Participants
|
34.86 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.39 • n=21 Participants
|
35.30 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.44 • n=10 Participants
|
35.22 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.87 • n=115 Participants
|
35.26 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.71 • n=24 Participants
|
|
Blood Pressure
Systolic Blood Pressure (SBP)
|
117.11 mm Hg
STANDARD_DEVIATION 11.53 • n=5 Participants
|
115.72 mm Hg
STANDARD_DEVIATION 10.78 • n=7 Participants
|
117.35 mm Hg
STANDARD_DEVIATION 10.13 • n=5 Participants
|
118.67 mm Hg
STANDARD_DEVIATION 11.11 • n=4 Participants
|
118.34 mm Hg
STANDARD_DEVIATION 11.37 • n=21 Participants
|
119.86 mm Hg
STANDARD_DEVIATION 11.42 • n=10 Participants
|
120.72 mm Hg
STANDARD_DEVIATION 11.36 • n=115 Participants
|
118.24 mm Hg
STANDARD_DEVIATION 11.13 • n=24 Participants
|
|
Blood Pressure
Diastolic Blood Pressure (DBP)
|
75.12 mm Hg
STANDARD_DEVIATION 7.31 • n=5 Participants
|
74.40 mm Hg
STANDARD_DEVIATION 7.70 • n=7 Participants
|
75.83 mm Hg
STANDARD_DEVIATION 6.76 • n=5 Participants
|
76.61 mm Hg
STANDARD_DEVIATION 7.07 • n=4 Participants
|
76.94 mm Hg
STANDARD_DEVIATION 6.31 • n=21 Participants
|
77.87 mm Hg
STANDARD_DEVIATION 6.82 • n=10 Participants
|
78.38 mm Hg
STANDARD_DEVIATION 6.23 • n=115 Participants
|
76.44 mm Hg
STANDARD_DEVIATION 6.97 • n=24 Participants
|
|
Waist and Hip Circumference
Waist Circumference
|
109.13 centimeters (cm)
STANDARD_DEVIATION 14.10 • n=5 Participants
|
107.42 centimeters (cm)
STANDARD_DEVIATION 10.70 • n=7 Participants
|
111.47 centimeters (cm)
STANDARD_DEVIATION 12.58 • n=5 Participants
|
107.31 centimeters (cm)
STANDARD_DEVIATION 12.06 • n=4 Participants
|
110.18 centimeters (cm)
STANDARD_DEVIATION 10.80 • n=21 Participants
|
109.99 centimeters (cm)
STANDARD_DEVIATION 11.49 • n=10 Participants
|
109.15 centimeters (cm)
STANDARD_DEVIATION 12.95 • n=115 Participants
|
109.24 centimeters (cm)
STANDARD_DEVIATION 12.10 • n=24 Participants
|
|
Waist and Hip Circumference
Hip Circumference
|
119.76 centimeters (cm)
STANDARD_DEVIATION 12.36 • n=5 Participants
|
118.55 centimeters (cm)
STANDARD_DEVIATION 9.42 • n=7 Participants
|
120.29 centimeters (cm)
STANDARD_DEVIATION 11.51 • n=5 Participants
|
117.65 centimeters (cm)
STANDARD_DEVIATION 11.13 • n=4 Participants
|
117.30 centimeters (cm)
STANDARD_DEVIATION 14.96 • n=21 Participants
|
119.43 centimeters (cm)
STANDARD_DEVIATION 11.45 • n=10 Participants
|
118.01 centimeters (cm)
STANDARD_DEVIATION 11.43 • n=115 Participants
|
118.70 centimeters (cm)
STANDARD_DEVIATION 11.83 • n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=28 Participants
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)
n=26 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=24 Participants
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)
n=25 Participants
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)
n=32 Participants
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)
n=22 Participants
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)
n=23 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Percent Change in Body Weight From Baseline to 24 Week Endpoint
|
-2.21 percent change
Standard Error 0.81
|
0.48 percent change
Standard Error 0.84
|
-6.12 percent change
Standard Error 0.86
|
-8.53 percent change
Standard Error 0.80
|
-6.61 percent change
Standard Error 0.79
|
-7.05 percent change
Standard Error 0.85
|
-4.71 percent change
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=28 Participants
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)
n=26 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=24 Participants
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)
n=25 Participants
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)
n=32 Participants
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)
n=22 Participants
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)
n=23 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
The Mean Change in Body Weight From Baseline to 24 Week Endpoint
|
-2.37 kilograms
Standard Error 0.82
|
0.45 kilograms
Standard Error 0.85
|
-6.41 kilograms
Standard Error 0.87
|
-8.15 kilograms
Standard Error 0.81
|
-6.49 kilograms
Standard Error 0.79
|
-7.06 kilograms
Standard Error 0.85
|
-4.68 kilograms
Standard Error 0.87
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 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.
Outcome measures
| Measure |
Placebo
n=49 Participants
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)
n=49 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=48 Participants
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)
n=49 Participants
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)
n=52 Participants
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)
n=50 Participants
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)
n=46 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve a Minimum of 10% Weight Loss From Baseline at 24 Weeks
|
10.2 percentage of participants
|
0.0 percentage of participants
|
18.8 percentage of participants
|
34.7 percentage of participants
|
21.2 percentage of participants
|
18.0 percentage of participants
|
6.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=30 Participants
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)
n=27 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=24 Participants
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)
n=26 Participants
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)
n=33 Participants
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)
n=22 Participants
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)
n=25 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Change in Heart Rate From Baseline to 24 Week Endpoint
|
-0.69 beats per minute (bpm)
Standard Error 1.51
|
-3.34 beats per minute (bpm)
Standard Error 1.60
|
-1.37 beats per minute (bpm)
Standard Error 1.67
|
6.11 beats per minute (bpm)
Standard Error 1.60
|
2.19 beats per minute (bpm)
Standard Error 1.44
|
-2.66 beats per minute (bpm)
Standard Error 1.72
|
-2.46 beats per minute (bpm)
Standard Error 1.63
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: ITT
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.
Outcome measures
| Measure |
Placebo
n=30 Participants
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)
n=27 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=24 Participants
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)
n=26 Participants
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)
n=33 Participants
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)
n=22 Participants
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)
n=25 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Change in Blood Pressure From Baseline to 24 Week Endpoint
Systolic Blood Pressure
|
-2.84 mm Hg
Standard Error 1.67
|
-3.59 mm Hg
Standard Error 1.75
|
-3.77 mm Hg
Standard Error 1.84
|
3.25 mm Hg
Standard Error 1.76
|
-1.17 mm Hg
Standard Error 1.59
|
-0.43 mm Hg
Standard Error 1.90
|
0.95 mm Hg
Standard Error 1.80
|
|
Change in Blood Pressure From Baseline to 24 Week Endpoint
Diastolic Blood Pressure
|
-2.25 mm Hg
Standard Error 1.28
|
-3.84 mm Hg
Standard Error 1.35
|
-2.51 mm Hg
Standard Error 1.41
|
2.03 mm Hg
Standard Error 1.34
|
0.13 mm Hg
Standard Error 1.22
|
-2.87 mm Hg
Standard Error 1.45
|
-0.38 mm Hg
Standard Error 1.38
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=28 Participants
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)
n=23 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=23 Participants
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)
n=23 Participants
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)
n=31 Participants
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)
n=21 Participants
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)
n=25 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Change in Body Composition Using Dual Energy X-ray Absorptiometry (DXA) From Baseline to 24 Week Endpoint
Fat Mass
|
-2.40 kilograms (kg)
Standard Error 0.72
|
0.54 kilograms (kg)
Standard Error 0.76
|
-3.00 kilograms (kg)
Standard Error 0.75
|
-6.13 kilograms (kg)
Standard Error 0.71
|
-4.80 kilograms (kg)
Standard Error 0.67
|
-4.29 kilograms (kg)
Standard Error 0.77
|
-2.55 kilograms (kg)
Standard Error 0.73
|
|
Change in Body Composition Using Dual Energy X-ray Absorptiometry (DXA) From Baseline to 24 Week Endpoint
Lean Mass
|
-0.55 kilograms (kg)
Standard Error 0.41
|
0.15 kilograms (kg)
Standard Error 0.45
|
-1.92 kilograms (kg)
Standard Error 0.45
|
-1.85 kilograms (kg)
Standard Error 0.43
|
-0.71 kilograms (kg)
Standard Error 0.39
|
-1.08 kilograms (kg)
Standard Error 0.47
|
-1.48 kilograms (kg)
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=31 Participants
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)
n=27 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=24 Participants
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)
n=25 Participants
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)
n=32 Participants
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)
n=22 Participants
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)
n=25 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Change in Waist Circumference From Baseline to 24 Week Endpoint
|
-6.58 centimeter (cm)
Standard Error 2.44
|
-2.51 centimeter (cm)
Standard Error 2.62
|
-8.84 centimeter (cm)
Standard Error 2.77
|
-6.76 centimeter (cm)
Standard Error 2.71
|
-3.57 centimeter (cm)
Standard Error 2.38
|
-3.55 centimeter (cm)
Standard Error 2.88
|
-8.67 centimeter (cm)
Standard Error 2.68
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: ITT
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.
Outcome measures
| Measure |
Placebo
n=31 Participants
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)
n=27 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=24 Participants
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)
n=25 Participants
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)
n=32 Participants
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)
n=22 Participants
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)
n=25 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Percentage Change in Waist Circumference From Baseline to 24 Week Endpoint
|
-5.86 percent change
Standard Deviation 2.21
|
-2.22 percent change
Standard Deviation 2.38
|
-7.55 percent change
Standard Deviation 2.52
|
-5.96 percent change
Standard Deviation 2.46
|
-3.02 percent change
Standard Deviation 2.16
|
-3.11 percent change
Standard Deviation 2.62
|
-7.29 percent change
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: 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).
Outcome measures
| Measure |
Placebo
n=48 Participants
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)
n=49 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=45 Participants
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)
n=49 Participants
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)
n=48 Participants
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)
n=50 Participants
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)
n=43 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Change in Total Cholesterol From Baseline to 24 Weeks Endpoint
|
-0.12 millimole/Liter (mmol/L)
Standard Deviation 0.68
|
-0.13 millimole/Liter (mmol/L)
Standard Deviation 0.47
|
-0.04 millimole/Liter (mmol/L)
Standard Deviation 0.69
|
-0.01 millimole/Liter (mmol/L)
Standard Deviation 0.67
|
0.00 millimole/Liter (mmol/L)
Standard Deviation 0.68
|
0.17 millimole/Liter (mmol/L)
Standard Deviation 0.70
|
-0.13 millimole/Liter (mmol/L)
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: 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).
Outcome measures
| Measure |
Placebo
n=48 Participants
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)
n=49 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=45 Participants
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)
n=49 Participants
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)
n=48 Participants
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)
n=50 Participants
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)
n=43 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to 24 Weeks Endpoint
|
-0.02 millimole/Liter (mmol/L)
Standard Deviation 0.16
|
-0.05 millimole/Liter (mmol/L)
Standard Deviation 0.19
|
-0.03 millimole/Liter (mmol/L)
Standard Deviation 0.15
|
0.01 millimole/Liter (mmol/L)
Standard Deviation 0.15
|
0.06 millimole/Liter (mmol/L)
Standard Deviation 0.21
|
0.01 millimole/Liter (mmol/L)
Standard Deviation 0.17
|
-0.04 millimole/Liter (mmol/L)
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: 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).
Outcome measures
| Measure |
Placebo
n=48 Participants
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)
n=49 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=45 Participants
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)
n=49 Participants
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)
n=48 Participants
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)
n=49 Participants
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)
n=43 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to 24 Weeks Endpoint
|
-0.07 millimole/Liter (mmol/L)
Standard Deviation 0.57
|
-0.03 millimole/Liter (mmol/L)
Standard Deviation 0.44
|
0.00 millimole/Liter (mmol/L)
Standard Deviation 0.62
|
-0.00 millimole/Liter (mmol/L)
Standard Deviation 0.58
|
-0.07 millimole/Liter (mmol/L)
Standard Deviation 0.50
|
0.16 millimole/Liter (mmol/L)
Standard Deviation 0.65
|
-0.16 millimole/Liter (mmol/L)
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: 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).
Outcome measures
| Measure |
Placebo
n=48 Participants
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)
n=49 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=45 Participants
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)
n=49 Participants
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)
n=48 Participants
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)
n=50 Participants
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)
n=43 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Change in Triglycerides From Baseline to 24 Weeks Endpoint
|
-0.06 millimole/Liter (mmol/L)
Standard Deviation 0.61
|
-0.11 millimole/Liter (mmol/L)
Standard Deviation 0.48
|
-0.04 millimole/Liter (mmol/L)
Standard Deviation 0.66
|
0.04 millimole/Liter (mmol/L)
Standard Deviation 0.60
|
0.04 millimole/Liter (mmol/L)
Standard Deviation 0.55
|
0.03 millimole/Liter (mmol/L)
Standard Deviation 0.72
|
0.22 millimole/Liter (mmol/L)
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: ITT
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 = \[(sum of component items score (minus) lowest possible score/ possible raw score range)\*100\].
Outcome measures
| Measure |
Placebo
n=31 Participants
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)
n=26 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=24 Participants
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)
n=26 Participants
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)
n=34 Participants
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)
n=23 Participants
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)
n=26 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline for Obesity Weight Loss Quality of Life Instrument (OWL-QoL)
|
11.71 units on a scale
Standard Error 4.93
|
2.67 units on a scale
Standard Error 5.30
|
13.96 units on a scale
Standard Error 5.26
|
16.52 units on a scale
Standard Error 5.27
|
17.44 units on a scale
Standard Error 5.17
|
13.53 units on a scale
Standard Error 5.35
|
14.02 units on a scale
Standard Error 5.23
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Placebo
n=31 Participants
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)
n=27 Participants
Given orally, daily for 24 weeks.
|
Sibutramine (30 mg)/Metoprolol (200 mg)
n=24 Participants
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)
n=25 Participants
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)
n=34 Participants
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)
n=24 Participants
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)
n=26 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Vitality Scale of Medical Outcomes Short Form - 36 (SF-36) Scale
|
10.79 units on a scale
Standard Error 5.24
|
5.83 units on a scale
Standard Error 5.66
|
16.81 units on a scale
Standard Error 5.63
|
10.69 units on a scale
Standard Error 5.69
|
7.35 units on a scale
Standard Error 5.53
|
10.62 units on a scale
Standard Error 5.72
|
13.61 units on a scale
Standard Error 5.58
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Zero participants were analyzed due to the small sample size.
Analysis of change in HbA1c was not conducted due to an inadequate number of samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Zero participants were analyzed due to an inadequate number of samples.
Analysis of change in fasting glucose was not conducted due to an inadequate number of samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Zero participants were analyzed due to an inadequate number of samples.
Analysis of change in fasting insulin was not conducted due to an inadequate number of samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Zero participants were analyzed due to inadequate number of samples.
Analysis of change in insulin resistance was not conducted due to an inadequate number of samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks, 12 weeks, and 24 weeksPopulation: Zero participants were analyzed because of the low sample size.
Analysis of AUC was not conducted due to an inadequate number of samples collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks, 12 weeks, and 24 weeksPopulation: Zero participants were analyzed due to the small sample size.
Analysis of Cmax was not conducted due to an inadequate number of samples collected.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
LY377604 (75 mg)
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Sibutramine (30mg)/Metoprolol (200mg)
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
LY377604 (15 mg)/Sibutramine (30 mg)
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
LY377604 (40 mg)/Sibutramine (30 mg)
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
LY377604 (75 mg)/Sibutramine (30 mg)
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
LY377604 (75 mg)/Sibutramine (15 mg)
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=49 participants at risk
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)
n=49 participants at risk
Given orally, daily for 24 weeks.
|
Sibutramine (30mg)/Metoprolol (200mg)
n=48 participants at risk
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)/Sibutramine (30 mg)
n=49 participants at risk
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)/Sibutramine (30 mg)
n=52 participants at risk
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)
n=50 participants at risk
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)
n=46 participants at risk
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.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/49
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/46
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/46
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/46
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/49
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/52
|
0.00%
0/50
|
2.2%
1/46 • Number of events 1
|
|
Investigations
Blood pressure decreased
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/52
|
0.00%
0/50
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/46
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/46
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/46
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/46
|
Other adverse events
| Measure |
Placebo
n=49 participants at risk
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)
n=49 participants at risk
Given orally, daily for 24 weeks.
|
Sibutramine (30mg)/Metoprolol (200mg)
n=48 participants at risk
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)/Sibutramine (30 mg)
n=49 participants at risk
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)/Sibutramine (30 mg)
n=52 participants at risk
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)
n=50 participants at risk
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)
n=46 participants at risk
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.
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
6.5%
3/46 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.1%
2/49 • Number of events 2
|
4.1%
2/49 • Number of events 2
|
0.00%
0/48
|
4.1%
2/49 • Number of events 2
|
5.8%
3/52 • Number of events 4
|
0.00%
0/50
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
8.2%
4/49 • Number of events 4
|
4.1%
2/49 • Number of events 2
|
22.9%
11/48 • Number of events 11
|
18.4%
9/49 • Number of events 9
|
13.5%
7/52 • Number of events 8
|
10.0%
5/50 • Number of events 5
|
4.3%
2/46 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
2/49 • Number of events 2
|
6.1%
3/49 • Number of events 3
|
2.1%
1/48 • Number of events 1
|
6.1%
3/49 • Number of events 3
|
5.8%
3/52 • Number of events 3
|
10.0%
5/50 • Number of events 6
|
4.3%
2/46 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
1/49 • Number of events 1
|
8.2%
4/49 • Number of events 4
|
12.5%
6/48 • Number of events 6
|
40.8%
20/49 • Number of events 20
|
30.8%
16/52 • Number of events 16
|
20.0%
10/50 • Number of events 12
|
17.4%
8/46 • Number of events 9
|
|
Gastrointestinal disorders
Nausea
|
6.1%
3/49 • Number of events 5
|
0.00%
0/49
|
6.2%
3/48 • Number of events 3
|
8.2%
4/49 • Number of events 5
|
3.8%
2/52 • Number of events 2
|
6.0%
3/50 • Number of events 3
|
4.3%
2/46 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
10.2%
5/49 • Number of events 5
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
4.1%
2/49 • Number of events 2
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
0.00%
0/46
|
|
General disorders
Asthenia
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
6.1%
3/49 • Number of events 3
|
3.8%
2/52 • Number of events 2
|
4.0%
2/50 • Number of events 2
|
0.00%
0/46
|
|
General disorders
Fatigue
|
4.1%
2/49 • Number of events 2
|
10.2%
5/49 • Number of events 5
|
4.2%
2/48 • Number of events 2
|
2.0%
1/49 • Number of events 1
|
9.6%
5/52 • Number of events 5
|
2.0%
1/50 • Number of events 1
|
8.7%
4/46 • Number of events 4
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
5/49 • Number of events 5
|
10.2%
5/49 • Number of events 5
|
4.2%
2/48 • Number of events 2
|
4.1%
2/49 • Number of events 2
|
1.9%
1/52 • Number of events 1
|
8.0%
4/50 • Number of events 4
|
4.3%
2/46 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
4.1%
2/49 • Number of events 3
|
4.1%
2/49 • Number of events 2
|
4.2%
2/48 • Number of events 2
|
4.1%
2/49 • Number of events 2
|
5.8%
3/52 • Number of events 3
|
0.00%
0/50
|
0.00%
0/46
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
5/49 • Number of events 5
|
12.2%
6/49 • Number of events 9
|
8.3%
4/48 • Number of events 4
|
4.1%
2/49 • Number of events 2
|
7.7%
4/52 • Number of events 4
|
8.0%
4/50 • Number of events 4
|
10.9%
5/46 • Number of events 7
|
|
Infections and infestations
Urinary tract infection
|
6.1%
3/49 • Number of events 3
|
4.1%
2/49 • Number of events 2
|
6.2%
3/48 • Number of events 3
|
6.1%
3/49 • Number of events 3
|
0.00%
0/52
|
8.0%
4/50 • Number of events 4
|
8.7%
4/46 • Number of events 4
|
|
Infections and infestations
Viral infection
|
2.0%
1/49 • Number of events 1
|
2.0%
1/49 • Number of events 2
|
2.1%
1/48 • Number of events 1
|
10.2%
5/49 • Number of events 6
|
3.8%
2/52 • Number of events 3
|
0.00%
0/50
|
4.3%
2/46 • Number of events 2
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/48
|
6.1%
3/49 • Number of events 3
|
5.8%
3/52 • Number of events 3
|
0.00%
0/50
|
4.3%
2/46 • Number of events 2
|
|
Investigations
Blood creatine phosphokinase increased
|
4.1%
2/49 • Number of events 2
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
6.1%
3/49 • Number of events 3
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/46
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
1/49 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
4.1%
2/49 • Number of events 2
|
7.7%
4/52 • Number of events 4
|
4.0%
2/50 • Number of events 2
|
2.2%
1/46 • Number of events 1
|
|
Metabolism and nutrition disorders
Increased appetite
|
2.0%
1/49 • Number of events 1
|
6.1%
3/49 • Number of events 3
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/49 • Number of events 1
|
8.2%
4/49 • Number of events 4
|
6.2%
3/48 • Number of events 3
|
6.1%
3/49 • Number of events 3
|
1.9%
1/52 • Number of events 1
|
6.0%
3/50 • Number of events 4
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
6.2%
3/48 • Number of events 3
|
8.2%
4/49 • Number of events 4
|
3.8%
2/52 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.2%
4/49 • Number of events 4
|
2.0%
1/49 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
4.3%
2/46 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
4.1%
2/49 • Number of events 2
|
6.1%
3/49 • Number of events 3
|
8.3%
4/48 • Number of events 4
|
8.2%
4/49 • Number of events 4
|
13.5%
7/52 • Number of events 8
|
12.0%
6/50 • Number of events 6
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
6.0%
3/50 • Number of events 3
|
0.00%
0/46
|
|
Nervous system disorders
Headache
|
8.2%
4/49 • Number of events 4
|
6.1%
3/49 • Number of events 3
|
10.4%
5/48 • Number of events 5
|
10.2%
5/49 • Number of events 5
|
9.6%
5/52 • Number of events 6
|
8.0%
4/50 • Number of events 4
|
4.3%
2/46 • Number of events 2
|
|
Nervous system disorders
Hypoaesthesia
|
4.1%
2/49 • Number of events 3
|
6.1%
3/49 • Number of events 5
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
3.8%
2/52 • Number of events 2
|
0.00%
0/50
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.00%
0/49
|
6.1%
3/49 • Number of events 3
|
2.1%
1/48 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
0.00%
0/52
|
0.00%
0/50
|
0.00%
0/46
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/52
|
6.0%
3/50 • Number of events 3
|
0.00%
0/46
|
|
Psychiatric disorders
Anxiety
|
4.1%
2/49 • Number of events 3
|
0.00%
0/49
|
4.2%
2/48 • Number of events 2
|
2.0%
1/49 • Number of events 1
|
7.7%
4/52 • Number of events 4
|
0.00%
0/50
|
0.00%
0/46
|
|
Psychiatric disorders
Insomnia
|
4.1%
2/49 • Number of events 2
|
10.2%
5/49 • Number of events 5
|
6.2%
3/48 • Number of events 3
|
16.3%
8/49 • Number of events 8
|
13.5%
7/52 • Number of events 7
|
12.0%
6/50 • Number of events 6
|
4.3%
2/46 • Number of events 2
|
|
Psychiatric disorders
Stress
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/48
|
0.00%
0/49
|
5.8%
3/52 • Number of events 3
|
0.00%
0/50
|
0.00%
0/46
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.1%
2/49 • Number of events 2
|
4.1%
2/49 • Number of events 2
|
2.1%
1/48 • Number of events 1
|
8.2%
4/49 • Number of events 4
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
6.1%
3/49 • Number of events 3
|
0.00%
0/52
|
0.00%
0/50
|
2.2%
1/46 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/49
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
10.2%
5/49 • Number of events 5
|
5.8%
3/52 • Number of events 4
|
4.0%
2/50 • Number of events 2
|
2.2%
1/46 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.0%
1/49 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
6.1%
3/49 • Number of events 3
|
1.9%
1/52 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
2.2%
1/46 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
3.8%
2/52 • Number of events 2
|
6.0%
3/50 • Number of events 3
|
0.00%
0/46
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/49
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
4.1%
2/49 • Number of events 2
|
7.7%
4/52 • Number of events 4
|
2.0%
1/50 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60