ObesityPhase 2NCT00349635
A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.
A Phase 2 study testing Metformin and Metformin + Fenofibrate in people with Obesity, run by Solvay Pharmaceuticals at 3 sites in Finland.
Trial summary
To investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Obesity
- What is being tested?
- Metformin and Metformin + Fenofibrate
- How many people
- 148 participants
- Where
- 3 sitesFinland
- Study dates
- Oct 2004to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders, BMI ≥ 30 kg/m² and <40 kg/m².
Who cannot join
- Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level.
Trial locations and contacts
3 sites in 1 country.
About this study
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.
To investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet.
- Conditions
- Obesity
- Being tested
- Metformin and Metformin + Fenofibrate
- Keywords
- Weight loss and diet.
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin and Metformin + FenofibrateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Secondary outcomes (1)
Waist and hip circumference
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2006 (estimated)
- Study startOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 148 participants
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349635
- Sponsor's protocol ID
- C LF23-0121 04 01
- Other IDs
- 2004-001731-28, 2004
- Status last verified
- Aug 2007
- First submitted
- 6 Jul 2006
- Last updated
- 3 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00349635
- Acronym / sponsor ID
- C LF23-0121 04 01
- Conditions
- Obesity
- Keywords
- Weight loss and diet.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- First posted
- 7 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Both genders, BMI ≥ 30 kg/m² and <40 kg/m².
Key exclusion criteria (1 listed)
- Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin and Metformin + Fenofibrate | Drug | – |
Primary outcome
Weight
1 secondary outcome
Waist and hip circumference
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin and Metformin + Fenofibrate in people with Obesity, run by Solvay Pharmaceuticals at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2007.