NCT00116740

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

September 12, 2019

Status Verified

December 1, 2006

First QC Date

June 30, 2005

Last Update Submit

September 11, 2019

Conditions

Obesity

Keywords

Serotonin5-HT2cSatietyObesityAppetite suppressantWeight LossOverweight

Outcome Measures

Primary Outcomes (1)

  • Change in body weight

Secondary Outcomes (2)

  • Safety

  • Changes in waist circumference, hip circumference, and waist/hip ratio

Interventions

APD356DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • Smith SR, Prosser WA, Donahue DJ, Morgan ME, Anderson CM, Shanahan WR; APD356-004 Study Group. Lorcaserin (APD356), a selective 5-HT(2C) agonist, reduces body weight in obese men and women. Obesity (Silver Spring). 2009 Mar;17(3):494-503. doi: 10.1038/oby.2008.537. Epub 2008 Dec 4.

    PMID: 19057523DERIVED

Related Links

MeSH Terms

Conditions

ObesityAnorexiaWeight LossOverweight

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveBody Weight Changes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 1, 2005

Study Start

June 1, 2005

Study Completion

November 1, 2005

Last Updated

September 12, 2019

Record last verified: 2006-12

Locations

US(1)