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

NCT00642993 | Completed Phase 2 Results

• 2 other identifiers: P05483MK-7079-008
• Study Type: interventional
• Target: 401
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Overweight; Body Weight

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of Participants Demonstrating a Weight Loss ≥5% at Week 12

  Baseline and Week 12

• Percentage of Participants Demonstrating a Weight Loss ≥10% at Week 12

  Baseline and Week 12

• Mean Change From Baseline in Waist Circumference at Week 12

  Baseline and Week 12

• Mean Change From Baseline in Body Mass Index (BMI) at Week 12

  Baeline and Week 12

Study Arms (2)

SCH 497079

EXPERIMENTAL

SCH 497079, administered orally, once daily

Drug: SCH 497079

Placebo

PLACEBO COMPARATOR

Placebo capsules, administered orally, once daily

Drug: Placebo

Interventions

SCH 497079 DRUG

100 mg capsule administered orally

SCH 497079

Placebo DRUG

Placebo capsules matching SCH 497079 administered orally

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 18 years of age, of either sex, and of any race.
• Obese or overweight participants.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Obesity; Overweight; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2008
• First Posted: March 25, 2008
• Study Start: June 9, 2008
• Primary Completion: January 30, 2009
• Study Completion: January 30, 2009
• Last Updated: September 10, 2018
• Results First Posted: October 27, 2016

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share