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 by A 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001731-28-FI

Enrollment

135

Registered

2004-07-27

Start date

2004-09-24

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Trade Name: Lipanthyl 267 mg Product Name: Fenofibrate capsules Product Code: N/A Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Both genders, from 30 to 50 years old. Obese, with BMI > 30 kg/m2 and =65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate in a FIRST PHASE of the study the effect on weight loss of the combination of fenofibrate 267 mg per day and metformin 1700 mg per day, on top of a moderate balanced calorie-deficit diet as compared to metformin alone 1700 mg per day and to placebo, in obese patients not diagnosed with type 2 diabetes mellitus. To investigate, in a SECOND PHASE of the study, the effect on weight-loss maintenance of the combination of fenofibrate 267 mg per day and metformin 1700 mg per day, as compared to placebo on top of an eucaloricdiet, in the sub-set of patients who responded to the study treatment and/or to the hypocaloric diet in terms of weight loss in first phase of the study (at least 5% weight loss).;Secondary Objective: ;Primary end point(s): FIRST PHASE: Weight loss at endpoint after 26 weeks of treatment: absolute change between endpoint and baseline. SECOND PHASE: Absolute variation of weight between the end of the first phase and the end of the study.	—

Measure

Time frame

Main Objective: To investigate in a FIRST PHASE of the study the effect on weight loss of the combination of fenofibrate 267 mg per day and metformin 1700 mg per day, on top of a moderate balanced calorie-deficit diet as compared to metformin alone 1700 mg per day and to placebo, in obese patients not diagnosed with type 2 diabetes mellitus. To investigate, in a SECOND PHASE of the study, the effect on weight-loss maintenance of the combination of fenofibrate 267 mg per day and metformin 1700 mg per day, as compared to placebo on top of an eucaloricdiet, in the sub-set of patients who responded to the study treatment and/or to the hypocaloric diet in terms of weight loss in first phase of the study (at least 5% weight loss).;Secondary Objective: ;Primary end point(s): FIRST PHASE: Weight loss at endpoint after 26 weeks of treatment: absolute change between endpoint and baseline. SECOND PHASE: Absolute variation of weight between the end of the first phase and the end of the study.

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Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026