Completed

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

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What is being tested

Data Collection

Who is being recruted

Anorexia+9

+ Body Weight

+ Body Weight Changes

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2004
See protocol details

Summary

Principal SponsorEisai Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA 4-Week, Dose-ranging, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of APD356 in Obese Patients
NCT00104507
Principal SponsorEisai Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnorexiaBody WeightBody Weight ChangesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsWeight LossOvernutritionOverweight

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Pennington Biomedical Research Center

Baton Rouge, United StatesOpen Pennington Biomedical Research Center in Google Maps
CompletedOne Study Center