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

Phase 2

Completed

• Conditions: Obesity; Dyslipidemia

• Registration Number: NCT00345410
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-27
• Study First Submitted QC: 2006-06-27
• Study First Posted: 2006-06-28
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-18
• Last Update Posted: 2008-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Absolute change from baseline in body weight at 24 weeks

Secondary Outcome Measures

Name	Time	Method
- 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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇺🇸 Bridgewater, New Jersey, United States