Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia

Sanofi

Status and phase

Completed

Phase 2

Conditions

Obesity

Dyslipidemia

Treatments

Drug: AVE1625 B

Study type

Interventional

Funder types

Industry

Identifiers

NCT00345410

DRI6412

Details and patient eligibility

About

Primary objective: to assess the effect of AVE1625 on weight loss over a period of 24 weeks in abdominally obese patients with atherogenic dyslipidemia. Secondary objectives: - To assess the dose effect relationship of AVE1625 on HDL-cholesterol and triglycerides plasma levels over a period of 24 weeks - To assess the efficacy of AVE1625 on secondary parameters such as waist circumference and other metabolic parameters over a period of 24 weeks - To assess the safety and tolerabillity of AVE1625 over a period of 24 weeks.

Enrollment

345 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Abdominal obese patients with ·
Waist circumference > 102 cm in men and >88 cm in women
Dyslipidemia consisting of :
- Triglycerides ≥ 1.50 g/L (i.e 1.69 mmol/L) and ≤ 7.0 g/L(i.e. 7.90 mmol/L)AND/OR
- HDL-cholesterol < 50 mg/dL (i.e. 1.29 mmol/L) in women and < 40 mg/dL (i.e. 1.04 mmol/L) in men

Exclusion criteria

Pregnancy or lactation
Women of child-bearing potential with no medically approved contraception
Patients with type 1 diabetes
Patients with type 2 diabetes must be on a stable dose of oral antidiabetic drugs (excluding glitazones, exenatide, sulfonylurea and nateglinide) and should not receive insulin therapy
Patients with any clinically significant endocrine disease
Patients on anticoagulants (heparin, warfarin) or with bleeding disorders
Clinically relevant disease interfering with subject's safety or making implementation of the study protocol or interpretation of study results difficult
Patients with mental retardation or any clinically significant psychiatric disorder
History or concurrent substance abuse (other than nicotine or caffeine especially marijuana or hashish)
Chronic systemic corticotherapy
Patients with weight change > 5kg within 3 months prior to screening
Patients should not have received anti-obesity drugs or other drugs for weight reduction in the 3 months prior to screening.
The investigator will evaluate whether there are other reasons why a patient may not participate