Back to resultsA Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.
Primary Purpose
Obesity
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Metformin and Metformin + Fenofibrate
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Weight loss and diet.
Eligibility Criteria
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.
Sites / Locations
- Site 1
- Site 3
- Site 2
Outcomes
Primary Outcome Measures
Weight
Secondary Outcome Measures
Waist and hip circumference
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00349635
Brief Title
A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.
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 Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Solvay Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
To investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight loss and diet.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
148 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Metformin and Metformin + Fenofibrate
Primary Outcome Measure Information:
Title
Weight
Secondary Outcome Measure Information:
Title
Waist and hip circumference
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 1
City
Helsinki
Country
Finland
Facility Name
Site 3
City
Kuopio
Country
Finland
Facility Name
Site 2
City
Oulu
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
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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