A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.
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.
2 other identifiers
interventional
148
1 country
3
Brief Summary
To investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 obesity
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 6, 2006
CompletedFirst Posted
Study publicly available on registry
July 7, 2006
CompletedSeptember 3, 2007
August 1, 2007
July 6, 2006
August 31, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight
Secondary Outcomes (1)
Waist and hip circumference
Interventions
Eligibility Criteria
You may qualify if:
- Both genders, BMI ≥ 30 kg/m² and \<40 kg/m².
You may not qualify if:
- Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Site 1
Helsinki, Finland
Site 3
Kuopio, Finland
Site 2
Oulu, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 6, 2006
First Posted
July 7, 2006
Study Start
October 1, 2004
Last Updated
September 3, 2007
Record last verified: 2007-08