A double-blind, 3-arm study on weight loss with combination of micronised fenofibrate 267 mg and metformin 1700 mg per day compared to metformin 1700 mg and placebo, at 6 months, in obese patients, Followed byA double-blind, 2-arm investigation of weight-loss maintance with same combination of micronised fenofibrate 267 mg and metformin 1700 mg compared to placebo, at 6 months, in the resporders. - A controlled study on the effect of combination of fenofibrate and metformin on weight-loss and weig

• Conditions: Obesity

• Registration Number: EUCTR2004-001731-28-FI
• Lead Sponsor: FOURNIER Laboratories Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Both genders, from 30 to 50 years old.
Obese, with BMI > 30 kg/m2 and < 40kg/m2.
Not previously included in the last 24 weeks in a intervention study (either a pharmacology one with an anti-obesity drug-already registered or in development-, or a lifestyle modification one with a Very Low Caloric Diet).
In absence of previous diagnosis of T2DM, or with FPG levels less than 7.0 mmol/L at inclusion.
With reliable method of contraception in female at child bearing potential and with negative pregnancy test (serum or urine B-HCG), at inclusion.
Not currently treated or treated in the last 30 days with fibrate, a statin or with any glucose lowering agent, and without a clear indication for such therapy.
With written informed consent.
Criterion fo randomisation in the second phase:
Weight loss responders, defined as with at least 5% weight loss in the first phase of the trial under hypocaloric diet and study treatment.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Female at pre-menopause stage with menstrual irregularities.
Known abnormal thyroid hormonen levels, or high thyroid stimulating hormone (TSH) level.
Having stop smoking within the last 12 weeks.
Included in the last 24 weeks in an obesity intervention study with anti-obesity drug or with a Very Low Caloric Diet.
Plasma creatinine levels > 115 µmol/L in male and > 95 µmol/L in female.
Known hypersensitivity to fibrates or metformin chlorhydrate.
Treated with cyclosporin A, anti-vitamin K, cortico-streroids or protease inhibitors.
Current chronic pancreatitis, or identifield risk or known history of acute pancreatitis or with TG level > 11.0 mmol/L (at risk of pancreatitis).
Current chronic liver diseases, AST and/or ALT > 1.5 times the upper normal limit (UNL).
Known cholelithiasis in absence of cholecystectomy.
Past medical history of myositis, myopathy or rhabdomyolosis.
Creatine phosphokinase (CK) > 3 times UNL.
With any other severe pathology such as cancer or mental illness.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified