Safety and Efficacy of APD356 in the Treatment of Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2005-11-30

Brief Summary

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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 a preliminary assessment of the safety and efficacy of APD356, when administered daily for 12 weeks, in obese subjects who are otherwise healthy. Subjects who are on concomitant medications for control of hypertension or blood lipids may qualify.

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Detailed Description

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This is a double-blind, placebo-controlled, randomized, parallel group study. Three different doses of APD356 or placebo will be administered daily for 12 weeks, to obese, male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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APD356

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or nonpregnant, nonlactating females aged 18-65 years (inclusive)
* Body mass index (BMI) of 30-45 kg/m2
* Non-smoker
* No concomitant medications other than hypertension medications (stable \> 90 days) and/or statins (stable \> 90 days)
* No past treatment with drugs associated with the development of pulmonary hypertension or cardiac valvular insufficiency
* No more than mild mitral valve regurgitation and absence of aortic valve regurgitation upon screening echocardiogram

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes