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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 XL Drug: Placebo sibutramine Drug: Placebo Metoprolol XL Drug: Placebo LY377604 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | LY377604 + Sibutramine Hydrochloride Monohydrate: A Phase 2 Weight Loss Efficacy Study in Overweight/Obese Men and Women |
| Estimated Enrollment: | 350 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| placebo: Placebo Comparator |
Drug: Placebo sibutramine
given orally daily, for 24 weeks
Drug: Placebo Metoprolol XL
given daily,orally for 26 weeks
Drug: Placebo LY377604
given daily, orally for 24 weeks
|
| LY377604 (75mg): Experimental |
Drug: LY377604
Given daily orally for 24 weeks
Drug: Placebo sibutramine
given orally daily, for 24 weeks
Drug: Placebo Metoprolol XL
given daily,orally for 26 weeks
|
| sibutramine (30mg)/metoprolol XL (200mg): Active Comparator |
Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Metoprolol XL
given daily, orally for 26 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;100 mg at week 25 and 50 mg at week 26)
Drug: Placebo LY377604
given daily, orally for 24 weeks
|
| LY377604 (40mg)/sibutramine (30mg): Experimental |
Drug: LY377604
Given daily orally for 24 weeks
Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Placebo Metoprolol XL
given daily,orally for 26 weeks
|
| LY377604 (75mg)/sibutramine (30mg): Experimental |
Drug: LY377604
Given daily orally for 24 weeks
Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Placebo Metoprolol XL
given daily,orally for 26 weeks
|
| LY377604 (15mg)/sibutramine (30mg): Experimental |
Drug: LY377604
Given daily orally for 24 weeks
Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Placebo Metoprolol XL
given daily,orally for 26 weeks
|
| LY377604 (75mg)/sibutramine (15mg): Experimental |
Drug: LY377604
Given daily orally for 24 weeks
Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Placebo Metoprolol XL
given daily,orally for 26 weeks
|
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: | Eli Lilly ( Chief Medical Officer ) |
| Study ID Numbers: | 11892, I1L-MC-GAEB |
| Study First Received: | October 9, 2009 |
| Last Updated: | January 8, 2010 |
| ClinicalTrials.gov Identifier: | NCT00993421 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Overweight Sibutramine Body Weight Signs and Symptoms Therapeutic Uses Weight Loss Body Weight Changes Appetite Depressants Adrenergic beta-Antagonists Nutrition Disorders |
Anti-Arrhythmia Agents Antidepressive Agents Obesity Sympatholytics Cardiovascular Agents Metoprolol Antihypertensive Agents Pharmacologic Actions Anti-Obesity Agents Autonomic Agents Metoprolol succinate Adrenergic Antagonists Overnutrition Peripheral Nervous System Agents Central Nervous System Agents |