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

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349635
• Other study ID #: C LF23-0121 04 01
• Secondary ID: 2004-001731-28
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2006
• Last updated: August 31, 2007
• Start date: October 2004

Study information

• Verified date: August 2007
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Drug:
• Metformin and Metformin + Fenofibrate

Locations

Country	Name	City	State
Finland	Site 1	Helsinki
Finland	Site 3	Kuopio
Finland	Site 2	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight
Secondary	Waist and hip circumference