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A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.

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ClinicalTrials.gov Identifier: NCT00349635
Recruitment Status : Completed
First Posted : July 7, 2006
Last Update Posted : September 3, 2007
Information provided by:
Solvay Pharmaceuticals

Brief Summary:
To investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet.

Condition or disease Intervention/treatment Phase
Obesity Drug: Metformin and Metformin + Fenofibrate Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : October 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Weight

Secondary Outcome Measures :
  1. Waist and hip circumference

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Both genders, BMI ≥ 30 kg/m² and <40 kg/m².

Exclusion Criteria:

  • Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349635

Site 1
Helsinki, Finland
Site 3
Kuopio, Finland
Site 2
Oulu, Finland
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

ClinicalTrials.gov Identifier: NCT00349635     History of Changes
Other Study ID Numbers: C LF23-0121 04 01
First Posted: July 7, 2006    Key Record Dates
Last Update Posted: September 3, 2007
Last Verified: August 2007

Keywords provided by Solvay Pharmaceuticals:
Weight loss and diet.

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents