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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

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