A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: Metformin and Metformin + Fenofibrate (Drug)
Phase: Phase 2
Sponsored by: Solvay Pharmaceuticals
Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
To investigate the effect on body weight of a combination fenofibrate and metformin on top of
a moderate balanced calorie-deficit diet.
Official title: A Double-Blind, 3-Arm Study on Weight Loss With a Combination of Micronised Fenofibrate 267 mg and Metformin 1,700 mg Per Day Compared to Metformin 1,700 mg and to Placebo, at 6 Months, in Obese Patients, Followed by: A Double-Blind, 2-Arm Investigation of Weight-Loss Maintenance With the Same Combination of Micronised Fenofibrate 267 mg and Metformin 1,700 mg Compared to Placebo, at 6 Months, in the Responders.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Weight
Secondary outcome: Waist and hip circumference
Minimum age: 30 Years.
Maximum age: 50 Years.
- Both genders, BMI ≥ 30 kg/m² and <40 kg/m².
- Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH)
Locations and Contacts
Site 1, Helsinki, Finland
Site 2, Oulu, Finland
Site 3, Kuopio, Finland
Starting date: October 2004
Last updated: August 31, 2007