Dyslipidemia, Obesity
Conditions
Keywords
obesity and dyslipidemia
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.
Interventions
DRUGAVE1625 B
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in body weight at 24 weeks | — |
Secondary
| Measure | 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 | — |
Countries
United States
Outcome results
None listed