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Completed

NCT Number: NCT00642993

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCH 497079

Drug

100 mg capsule administered orally

Placebo

Drug

Placebo capsules matching SCH 497079 administered orally

Primary outcomes

  1. Mean Change From Baseline in Body Weight at Week 12

    Time frame: Baseline and 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.

Secondary outcomes

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

  3. Mean Change From Baseline in Waist Circumference at Week 12

    Time frame: Baseline and 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.

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

    Time frame: Baeline and 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 25, 2008
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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