NCT00642993

Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Participants (Study P05483)(COMPLETED)

A Multicenter, Randomized, Parallel-Group, Placebo-Controlled, Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of SCH 497079 on weight in obese and overweight participants. The primary measure of effectiveness is the change in body weight during treatment. Additional measures include waist circumference and body mass index (BMI). In addition, the safety of SCH 497079 in obese and overweight participants will be evaluated. The primary hypothesis is that treatment with SCH 497079 will be more efficacious than that with placebo with respect to the primary efficacy variable.

Detailed description

Following Screening, eligible participants will enroll in a Run-in Period. Participants who qualify for continuation in the study according to the entry criteria will be randomized to one of two treatment groups (SCH 497079 or placebo in a 2:1 ratio) with stratification according to gender. Baseline measurements for the primary efficacy endpoint, as well as secondary endpoints will be evaluated at the Randomization Visit (Visit 3). Following randomization, participants will be treated for 12 weeks with double-blind study drug as adjunct to a 500 kcal deficit diet. Participants will have scheduled visits after the Randomization Visit at 2 to 4 week intervals. Each participant will be encouraged to adhere to medication and dietary instructions.

Conditions

• Obesity
• Overweight
• Body Weight

Interventions

Type	Name	Description
DRUG	SCH 497079	100 mg capsule administered orally
DRUG	Placebo	Placebo capsules matching SCH 497079 administered orally

Timeline

• Start date: 2008-06-09
• Primary completion: 2009-01-30
• Completion: 2009-01-30
• First posted: 2008-03-25
• Last updated: 2018-09-10
• Results posted: 2016-10-27