Japanese Study of Rimonabant in Obese Patients With Dyslipidemia (VENUS)

A Randomized Double-blind, Placebo-controlled, Parallel-group, Fixed Single-dose Regimen (SR141716 20 mg), Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Patients With Dyslipidemia.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00434096

Enrollment

915

Registered

2007-02-12

Start date

2007-02-28

Completion date

2009-02-28

Last updated

2009-07-20

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

Conditions

Obesity

Keywords

Obesity disease, cannabinoid-1 receptor

Brief summary

The primary objective of this study is to assess the efficacy of SR141716 compared to placebo on body weight and triglycerides changes over a period of 52 weeks. Secondary objectives are: * To evaluate the effect of SR141716 compared to placebo over a period of 52 weeks, on HDL-cholesterol and visceral fat area. * To evaluate the safety of SR141716 compared to placebo over a period of 104 weeks. * To evaluate the pharmacokinetics of SR141716.

Interventions

DRUGrimonabant (SR141716)

oral administration once daily

DRUGplacebo

oral administration once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Body Mass Index (BMI) \> 25 kg/m² * Visceral Fat Area (VFA) \> 100 cm² * Triglycerides (TG) \> 150 mg/dL and \< 700 mg/dL, and/or HDL-cholesterol \< 40 mg/dL(Dyslipidemia) * At least 1 criteria of the following 2 comorbidities: * Impaired Glucose Tolerance or Type 2 diabetes * Hypertension

Exclusion criteria

* Patient with a secondary obesity. * Patients who have received the diet therapy for less than 8 weeks before start of the observation period. * Patients whose body weight changed by more than the variation of ± 2kg for screening period. * Low compliance to drug intake (\< 80%) and dietary instruction during the observation period. * Patients with type 1 diabetes. * Patients with a primary hyperlipidemia (i.e., familial hypercholesterolemia, familial combined hyperlipidemia and familial type III hyperlipidemia). * Patients with a LDL-cholesterol \> 190 mg/dL at any of Weeks -8 or -4. * Patients with a secondary hypertension.

Design outcomes

Primary

Measure	Time frame
triglycerides: relative change from baseline	Week 52
body weight: relative change from baseline	Week 52

Secondary

Measure	Time frame
HDL-cholesterol ;visceral fat area	Week 52
Safety: Adverse events	study period

Countries

Japan

Outcome results

None listed

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