Conditions: Obesity Overweight Body Weight
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 401
Healthy volunteers: no

Brief 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.

Arms:
arm 1: SCH 497079, administered orally, once daily arm 2: Placebo capsules, administered orally, once daily

Interventions: intervention 1: SCH 497079 intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg capsule administered orally intervention 2: Placebo capsules matching SCH 497079 administered orally

Protocol document: