NCT00104507CompletedPhase 2
A 4-Week, Dose-ranging, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of APD356 in Obese Patients
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eisai Inc.
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Change in body weight
Study Overview
Brief Summary
This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity.
The purpose of this study is to obtain preliminary assessment of the safety and efficacy of APD356, when administered daily for 28 days, in obese subjects who are otherwise healthy.
Detailed Description
This is a double-blind, placebo-controlled, randomized, parallel group study. Three different doses of APD356 or placebo will be administered daily for 28 days, to uncomplicated obese, male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male or nonpregnant, nonlactating females aged between 18 and 65 years (inclusive)
- •Body Mass Index (BMI) of 30-45 Kg/m^
- •Non-smoker
- •No concomitant medications
- •No past treatment with drugs associated with the development of pulmonary hypertension or cardiac valvular insufficiency
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in body weight
Secondary Outcomes
- Safety
- Changes in waist circumference, hip circumference and waist/hip ratio
Investigators
Study Sites (1)
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