NCT00092872
Completed
Phase 3
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of MK0557 in Obese Patients
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 359
- Primary Endpoint
- Safety and tolerability.
Overview
Brief Summary
This is a 1-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients after a very low calorie diet.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Obese men and nonpregnant women between the ages of 18 and 65 years with a body mass index (height to weight ratio) as required by the study.
Exclusion Criteria
- •Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)
Outcomes
Primary Outcomes
Safety and tolerability.
Time Frame: After 1 year of treatment
Body weight after 1 year of treatment.
Time Frame: After 1 year of treatment
Secondary Outcomes
- Waist circumference; Blood pressure, body fat mass, biochemical markers (fasting plasma, lipid profile, fasting plasma glucose, leptin, insulin, insulin sensitivity); body weight after 2 years(After 2 years)
Investigators
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