A Weight Loss Study in Overweight Men and Women
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ClinicalTrials.gov Identifier: NCT00993421 |
Recruitment Status :
Terminated
(Clinical trial terminated due to results from recent nonclinical studies)
First Posted : October 12, 2009
Results First Posted : June 2, 2011
Last Update Posted : June 3, 2011
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Obesity |
Interventions |
Drug: LY377604 Drug: Sibutramine Drug: Metoprolol Drug: Placebo sibutramine Drug: Placebo Metoprolol Drug: Placebo LY377604 |
Enrollment | 343 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Placebo | LY377604 (75 mg) | Sibutramine (30 mg)/Metoprolol (200 mg) | LY377604 (15 mg)/Sibutramine (30 mg) | LY377604 (40 mg)/Sibutramine (30 mg) | LY377604 (75 mg)/Sibutramine (30 mg) | LY377604 (75 mg)/Sibutramine (15 mg) |
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Placebo LY377604: given orally, daily for 24 weeks. Placebo sibutramine: given orally, daily for 24 weeks. Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper. |
Given orally, daily for 24 weeks. |
sibutramine (30 mg): Given orally, daily for 24 weeks. metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day. Placebo LY377604: given orally, daily for 24 weeks. |
LY377604 (15 mg): Given orally, daily for 24 weeks. sibutramine (30 mg): Given orally, daily for 24 weeks. Placebo metoprolol: Given orally, daily for 24 weeks. |
LY377604 (40 mg): Given orally, daily for 24 weeks. sibutramine (30 mg): Given orally, daily for 24 weeks. Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper. |
LY377604 (75 mg): Given orally, daily for 24 weeks. sibutramine (30 mg): Given orally, daily for 24 weeks. Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper. |
LY377604 (75 mg): Given orally, daily for 24 weeks. sibutramine (15 mg): Given orally, daily for 24 weeks. Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper. |
Period Title: Overall Study | |||||||
Started | 49 | 49 | 48 | 49 | 52 | 50 | 46 |
Completed | 5 | 4 | 5 | 4 | 6 | 4 | 4 |
Not Completed | 44 | 45 | 43 | 45 | 46 | 46 | 42 |
Reason Not Completed | |||||||
Adverse Event | 2 | 7 | 6 | 9 | 5 | 7 | 1 |
Sponsor Decision | 36 | 31 | 28 | 30 | 38 | 30 | 29 |
Lost to Follow-up | 3 | 5 | 5 | 0 | 0 | 0 | 6 |
Withdrawal by Subject | 3 | 2 | 3 | 3 | 3 | 5 | 3 |
Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Entry Criteria Exclusion | 0 | 0 | 1 | 3 | 0 | 1 | 0 |
Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
Protocol Violation | 0 | 0 | 0 | 0 | 0 | 2 | 1 |
Arm/Group Title | Placebo | LY377604 (75 mg) | Sibutramine (30 mg)/Metoprolol (200 mg) | LY377604 (15 mg)/Sibutramine (30 mg) | LY377604 (40 mg)/Sibutramine (30 mg) | LY377604 (75 mg)/Sibutramine (30 mg) | LY377604 (75 mg)/Sibutramine (15 mg) | Total | |
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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 | |
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[Not Specified]
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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 |
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Number Analyzed | 49 participants | 49 participants | 48 participants | 49 participants | 52 participants | 50 participants | 46 participants | 343 participants | |
Female |
41 83.7%
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42 85.7%
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38 79.2%
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39 79.6%
|
40 76.9%
|
41 82.0%
|
34 73.9%
|
275 80.2%
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Male |
8 16.3%
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7 14.3%
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10 20.8%
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10 20.4%
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12 23.1%
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9 18.0%
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12 26.1%
|
68 19.8%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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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%
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0 0.0%
|
1 2.0%
|
0 0.0%
|
1 2.0%
|
0 0.0%
|
2 0.6%
|
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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%
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Black or African American |
12 24.5%
|
5 10.2%
|
8 16.7%
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10 20.4%
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8 15.4%
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6 12.0%
|
7 15.2%
|
56 16.3%
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White |
36 73.5%
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43 87.8%
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39 81.3%
|
34 69.4%
|
43 82.7%
|
42 84.0%
|
36 78.3%
|
273 79.6%
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More than one race |
1 2.0%
|
1 2.0%
|
1 2.1%
|
3 6.1%
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1 1.9%
|
1 2.0%
|
2 4.3%
|
10 2.9%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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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) |
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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) |
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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) |
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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.
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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) |
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 |