Safety and Efficacy of APD356 in the Treatment of Obesity

A 12-Week, Dose-Ranging, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of APD356 in Obese Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00116740

Enrollment

400

Registered

2005-07-01

Start date

2005-06-30

Completion date

2005-11-30

Last updated

2019-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Serotonin, 5-HT2c, Satiety, Obesity, Appetite suppressant, Weight Loss, Overweight

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 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.

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 12 weeks, to obese, male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.

Interventions

DRUGAPD356

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change in body weight	—

Secondary

Measure	Time frame
Safety	—
Changes in waist circumference, hip circumference, and waist/hip ratio	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026