Phase 2
Completed N=401
Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Participants (Study P05483)(COMPLETED)
Obesity · Overweight · Body Weight
Source: ClinicalTrials.gov NCT00642993 ↗
Enrolled (actual)
401
Serious AEs
1.5%
Results posted
Oct 2016
Primary outcomePrimary: Mean Change From Baseline in Body Weight at Week 12 — -0.51; -0.92 Kilogram — p=0.187
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Body Weight at Week 12 |
-0.51; -0.92 | 0.187 |
| SECONDARY Percentage of Participants Demonstrating a Weight Loss ≥5% at Week 12 |
7.1; 11.5 | 0.140 |
| SECONDARY Percentage of Participants Demonstrating a Weight Loss ≥10% at Week 12 |
1.6; 0.8 | 0.515 |
| SECONDARY Mean Change From Baseline in Waist Circumference at Week 12 |
-1.22; -0.94 | 0.543 |
| SECONDARY Mean Change From Baseline in Body Mass Index (BMI) at Week 12 |
-0.18; -0.32 | 0.231 |
Eligibility Criteria
Inclusion Criteria
- >= 18 years of age, of either sex, and of any race.
- Obese or overweight participants.
Exclusion Criteria
- Participants who have a history of major eating disorders, gastrointestinal (GI) surgery, active serious cardiovascular, pulmonary, endocrine, neurologic, infectious, GI, hepatic, renal, hematologic, immunologic or psychiatric disease or diabetes.
Data sourced from ClinicalTrials.gov (NCT00642993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.