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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Three Doses of AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia

Conditions
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Obesity, Dyslipidemia

Intervention / Treatment
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* Drug: AVE1625 B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AVE1625 B|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in body weight at 24 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - relative change from baseline to 24 weeks in plasma HDL-cholesterol and triglycerides levels ; - change from baseline to 24 weeks in waist circumference ; Other criteria: glycemic control parameters. |  |  | 
| Safety: physical examination, vital signs, adverse events, ECG, laboratory tests. |  |  | 
| Pharmacokinetics: plasma AVE1625 concentrations |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity and dyslipidemia