Japanese Dose-Response Study of Rimonabant in Obese Patients

Sanofi527 enrolled

Overview

The primary objective is to verify the dose-response relationship of rimonabant on body weight change. The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and the pharmacokinetics of SR141716.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

527

Conditions

Obesity

Interventions

rimonabant (SR141716)DRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Body Mass Index ≥25 kg/m² * Viceral Fat Area ≥ 100 cm² * Diet therapy for more than 8 weeks before start of the placebo observation period * Stable weight (variation \< ±3kg within 8 weeks before start of observation period) * At least 2 criteria of the following 3 comorbidities: Impaired Glucose Tolerance or Type 2 diabetes, Dyslipidemia (hypertriglyceridemia and/or low HDL-choresterol), Hypertension

Locations (1)

Sanofi-Aventis

Tokyo, Japan

Outcomes

Primary Outcomes

absolute change in body weight from baseline to Week 24

Secondary Outcomes

Efficacy: body weight, visceral fat area, waist circumference, fasting plasma glucose, HbA1c, triglyceride, HDL-cholesterol, blood pressure

Safety:adverse events, laboratory tests, ECGs

Pharmacokinetics: SR141716 plasma trough concentrations

Data from ClinicalTrials.gov

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