Trial | NCT00104507  Report issue

Title

Safety and Efficacy of APD356 in the Treatment of Obesity
A 4-Week, Dose-ranging, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of APD356 in Obese Patients

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    400
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.
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 Started
Dec 31
2004
Study Completion
May 31
2005
Last Update
Sep 12
2019

Drug APD356

Criteria 

Healthy male or nonpregnant, nonlactating females aged between 18 and 65 years (inclusive)
Body Mass Index (BMI) of 30-45 Kg/m^2.
Non-smoker
No concomitant medications
No past treatment with drugs associated with the development of pulmonary hypertension or cardiac valvular insufficiency
No Results Posted