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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642993
• Other study ID #: P05483
• Secondary ID: MK-7079-008
• Status: Completed
• Phase: Phase 2
• Start date: June 9, 2008
• Est. completion date: January 30, 2009

Study information

• Verified date: August 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: January 30, 2009
• Est. primary completion date: January 30, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

Drug:
• SCH 497079
100 mg capsule administered orally
• Placebo
Placebo capsules matching SCH 497079 administered orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Body Weight at Week 12	Participant's body weight was measured in kilograms. For participants who discontinued during the study, last observation carried forward (LOCF) approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.	Baseline and Week 12
Secondary	Percentage of Participants Demonstrating a Weight Loss =5% at Week 12	For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.	Baseline and Week 12
Secondary	Percentage of Participants Demonstrating a Weight Loss =10% at Week 12	For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.	Baseline and Week 12
Secondary	Mean Change From Baseline in Waist Circumference at Week 12	Participant's waist circumference was measured in centimeters. For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.	Baseline and Week 12
Secondary	Mean Change From Baseline in Body Mass Index (BMI) at Week 12	For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.; Per protocol, participants were either obese (BMI =30 kg/m^2 and =40 kg/m^2) or overweight (BMI =27 kg/m^2 and <30 kg/m^2) at enrollment.	Baeline and Week 12