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| Sponsor: | Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00993421 |
Purpose
The purpose of this study is to determine if LY377604 + sibutramine work better than LY377604 or sibutramine alone in the treatment of obesity.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: LY377604 Drug: Sibutramine Drug: Metoprolol Drug: Placebo sibutramine Drug: Placebo Metoprolol Drug: Placebo LY377604 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | LY377604 + Sibutramine Hydrochloride Monohydrate: A Phase 2 Weight Loss Efficacy Study in Overweight/Obese Men and Women |
| Enrollment: | 343 |
| Study Start Date: | October 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: placebo |
Drug: Placebo sibutramine
given daily, orally for 24 weeks
Drug: Placebo Metoprolol
given daily, orally for 26 weeks (24 weeks plus 2 weeks of taper)
Drug: Placebo LY377604
given daily, orally for 24 weeks
|
| Experimental: LY377604 (75 mg) |
Drug: LY377604
Given daily, orally for 24 weeks
Drug: Placebo sibutramine
given daily, orally for 24 weeks
Drug: Placebo Metoprolol
given daily, orally for 26 weeks (24 weeks plus 2 weeks of taper)
|
| Active Comparator: sibutramine (30 mg)/metoprolol (200 mg) |
Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Metoprolol
given daily, orally for 24 weeks (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).
|
| Experimental: LY377604 (40 mg)/sibutramine (30 mg) |
Drug: LY377604
Given daily, orally for 24 weeks
Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Placebo Metoprolol
given daily, orally for 26 weeks (24 weeks plus 2 weeks of taper)
|
| Experimental: LY377604 (75 mg)/sibutramine (30 mg) |
Drug: LY377604
Given daily, orally for 24 weeks
Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Placebo Metoprolol
given daily, orally for 26 weeks (24 weeks plus 2 weeks of taper)
|
| Experimental: LY377604 (15 mg)/sibutramine (30 mg) |
Drug: LY377604
Given daily, orally for 24 weeks
Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Placebo Metoprolol
given daily, orally for 26 weeks (24 weeks plus 2 weeks of taper)
|
| Experimental: LY377604 (75 mg)/sibutramine (15 mg) |
Drug: LY377604
Given daily, orally for 24 weeks
Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Placebo Metoprolol
given daily, orally for 26 weeks (24 weeks plus 2 weeks of taper)
|
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 21 Study Locations| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT-5 hours, EST) | Eli Lilly and Company |
More Information
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00993421 History of Changes |
| Other Study ID Numbers: | 11892, I1L-MC-GAEB |
| Study First Received: | October 9, 2009 |
| Results First Received: | May 11, 2011 |
| Last Updated: | June 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Obesity Weight Loss Overweight Overnutrition Nutrition Disorders Body Weight Signs and Symptoms Body Weight Changes Metoprolol Metoprolol succinate Sibutramine Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Appetite Depressants Anti-Obesity Agents Central Nervous System Agents Antidepressive Agents |