Atherogenic DyslipidaemiaPhase 2NCT01271751
Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal Obesity
A Phase 2 study testing GFT505 80mg in people with Atherogenic Dyslipidaemia and Abdominal Obesity, run by Genfit at 47 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of GFT505 80mg in reducing serum Triglycerides (TG) and increasing High Density Lipoprotein Cholesterol (HDL-C) levels compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity, and to assess the tolerability and safety of once-a-day… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atherogenic Dyslipidaemia, Abdominal Obesity
- What is being tested?
- GFT505 80mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 47 sitesin 3 countries
- Study dates
- Jan 2009to Nov 2009
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or post-menopausal female.
- Waist circumference ≥102cm for male, ≥ 88cm for female.
- Atherogenic dislipidaemia inadequately controlled despite Therapeutic Lifestyle Change (TLC) recommendations (diet and exercise).
- 150≤ fasting TG ≤ 600 mg/dL (1.69 ≤ fasting TG ≤ 6.78 mmol/L) at V2.
- Fasting HDL-C ≤ 40 mg/dL (≤ 1.03 mmol/L) for male, HDL-C ≤ 45 mg/dL (≤ 1.16 mmol/L) for female at V2.
Who cannot join
- Body Mass Index (BMI) ≥ 40 kg/m².
- Blood Pressure > 160 / 95 mmHg.
- Type I or type II Diabetes Mellitus.
Trial locations and contacts
47 sites in 3 countries.
47 sites in 3 countries
France36 sites
Site n°36
Aigrefeuille-sur-Maine, 44140
Site n°78
Angers, 49000
Site n°79
Angers, 49000
Site n°80
Angers, 49000
Site n°82
Angers, 49000
Site n°21
Bauné, 49140
Site n°16
Beaucouzé, 49070
Site n°18
Briollay, 49125
Site n°14
Cholet, 49300
Site n°26
Cholet, 49300
Site n°42
Haute-Goulaine, 44115
Site n°45
Héric, 44810
Site n°32
La Chapelle-sur-Erdre, 44240
Site n°11
La Jubaudière, 49510
Site n°30
La Montagne, 44620
Site n°91
Laval, 53000
Site n°23
Le Mesnil-en-Vallée, 49410
Site n°35
Le Temple-de-Bretagne, 44360
Site n°12
Les Ponts-de-Cé, 49130
Site n°17
Montreuil-Juigné, 49460
Site n°74
Montrevault, 49110
Site n°10
Murs-Erigné, 49610
Site n°19
Murs-Erigné, 49610
Site n°40
Nantes, 44000
Site n°37
Nantes, 44100
Site n°31
Nantes, 44300
Site n°34
Nantes, 44300
Site n°41
Nort-sur-Erdre, 44390
Site n°33
Orvault, 44700
Site n°1
Paris, 75013
Site n°38
Saint-Étienne-de-Montluc, 44360
Site n°39
Sautron, 44880
Site n°13
Segré, 49500
Site n°75
Tiercé, 49125
Site n°77
Tiercé, 49125
Site n°20
Vihiers, 49310
Romania6 sites
Site n°64
Brasov
Site n°61
Bucharest, 010243
Site n°60
Bucharest, Sector 2
Site n°63
Bucharest, Sector 2
Site n°62
Bucharest
Site n°65
Craiova
Tunisia5 sites
Site n°52
Bab Sâadoun Tunis, 1029
Site n°53
Bab Sâadoun Tunis, 1029
Site n°50
Tunis, 1007
Site n°51
Tunis, 1007
Site n°55
Tunis, 1089
About this study
Official title: A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80mg) Orally Administered Once Daily for 28 Days in Atherogenic Dyslipidaemic Patients With Abdominal Obesity. A Double Blind, Placebo-controlled and Randomized Study.
The purpose of this study is to evaluate the efficacy of GFT505 80mg in reducing serum Triglycerides (TG) and increasing High Density Lipoprotein Cholesterol (HDL-C) levels compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 28 days.
Read the detailed description
The study period per patient is 7 to 14 weeks: a screening period (1 to 8 weeks) will precede a 4-week double-blind treatment period and a 2-week follow-up period.
During the screening period, patients will be asked to start or continue adequate diet and exercise and to stop their lipid-lowering medication (for not treatment-naïve patients). For patient taking any lipid-regulating medication, a minimum of 8-week wash-out from lipid-regulating therapies (fibrates, statins, …) is required.
- Conditions
- Atherogenic Dyslipidaemia, Abdominal Obesity
- Being tested
- GFT505 80mg, Placebo
- Keywords
- Atherogenic-dyslipidaemia, PPARs
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFT505 80mgDrug
hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast
PlaceboDrug
hard gelatin capsules, oral administration, 4 capsules per day before breakfast
| Study group | Role | What they receive |
|---|---|---|
| GFT505 80mg | Experimental | Not described Receives: Drug: GFT505 80mg |
| Matching placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in serum Triglycerides (TG) level
To evaluate the efficacy of GFT505 80mg in reducing serum TG compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)
Measured: 28 days
Increase in serum High Density Lipoprotein Cholesterol (HDL-C) level
To evaluate the efficacy of GFT505 80mg in increasing HDL-C levels compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)
Measured: 28 days
Secondary outcomes (2)
Decrease in Low Density Lipoprotein Cholesterol (LDL-C) levels
To evaluate the efficacy of GFT505 80mg in reducing LDL-C levels compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)
Measured: 28 days
Decrease in non-HDL-C (High Density Lipoprotein Cholesterol) levels
To evaluate the efficacy of GFT505 80mg in reducing non-HDL-C levels compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atherogenic DyslipidaemiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genfit
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rémy Hanf, Development Director, Study director, GENFIT, FranceEric BRUCKERT, Pr., Study chair, University Hospital of Paris 6, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271751
- Sponsor's protocol ID
- GFT505-208-3
- Other IDs
- 2008-005779-86, 2008
- Status last verified
- Jan 2011
- First submitted
- 6 Jan 2011
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Staels B, Rubenstrunk A, Noel B, Rigou G, Delataille P, Millatt LJ, Baron M, Lucas A, Tailleux A, Hum DW, Ratziu V, Cariou B, Hanf R. Hepatoprotective effects of the dual peroxisome proliferator-activated receptor alpha/delta agonist, GFT505, in rodent models of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Hepatology. 2013 Dec;58(6):1941-52. doi: 10.1002/hep.26461. Epub 2013 Oct 29.
PubMed 23703580Cariou B, Zair Y, Staels B, Bruckert E. Effects of the new dual PPAR alpha/delta agonist GFT505 on lipid and glucose homeostasis in abdominally obese patients with combined dyslipidemia or impaired glucose metabolism. Diabetes Care. 2011 Sep;34(9):2008-14. doi: 10.2337/dc11-0093. Epub 2011 Aug 4.
PubMed 21816979
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80mg) Orally Administered Once Daily for 28 Days in Atherogenic Dyslipidaemic Patients With Abdominal Obesity. A Double Blind, Placebo-controlled and Randomized Study.
- ClinicalTrials.gov ID
- NCT01271751
- Acronym / sponsor ID
- GFT505-208-3
- Conditions
- Atherogenic Dyslipidaemia, Abdominal Obesity
- Keywords
- Atherogenic-dyslipidaemia, PPARs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- GenfitIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 7 Jan 2011 (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.
The purpose of this study is to evaluate the efficacy of GFT505 80mg in reducing serum Triglycerides (TG) and increasing High Density Lipoprotein Cholesterol (HDL-C) levels compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 28 days.
Detailed description
The study period per patient is 7 to 14 weeks: a screening period (1 to 8 weeks) will precede a 4-week double-blind treatment period and a 2-week follow-up period.
During the screening period, patients will be asked to start or continue adequate diet and exercise and to stop their lipid-lowering medication (for not treatment-naïve patients). For patient taking any lipid-regulating medication, a minimum of 8-week wash-out from lipid-regulating therapies (fibrates, statins, …) is required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GFT505 80mg | Experimental | Drug: GFT505 80mg |
| Matching placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or post-menopausal female.
- Waist circumference ≥102cm for male, ≥ 88cm for female.
- Atherogenic dislipidaemia inadequately controlled despite Therapeutic Lifestyle Change (TLC) recommendations (diet and exercise).
- 150≤ fasting TG ≤ 600 mg/dL (1.69 ≤ fasting TG ≤ 6.78 mmol/L) at V2.
- Fasting HDL-C ≤ 40 mg/dL (≤ 1.03 mmol/L) for male, HDL-C ≤ 45 mg/dL (≤ 1.16 mmol/L) for female at V2.
Key exclusion criteria (3 listed)
- Body Mass Index (BMI) ≥ 40 kg/m².
- Blood Pressure > 160 / 95 mmHg.
- Type I or type II Diabetes Mellitus.
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 |
|---|---|---|
| GFT505 80mghard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast | Drug | GFT505 80mg |
| Placebohard gelatin capsules, oral administration, 4 capsules per day before breakfast | Drug | Matching placebo |
Primary outcome
Decrease in serum Triglycerides (TG) level
Time frame: 28 days
To evaluate the efficacy of GFT505 80mg in reducing serum TG compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)
Increase in serum High Density Lipoprotein Cholesterol (HDL-C) level
Time frame: 28 days
To evaluate the efficacy of GFT505 80mg in increasing HDL-C levels compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)
2 secondary outcomes
Decrease in Low Density Lipoprotein Cholesterol (LDL-C) levels
Time frame: 28 days
Decrease in non-HDL-C (High Density Lipoprotein Cholesterol) levels
Time frame: 28 days
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 7 Jan 2011.
- Derived from this study: PubMed 23703580Staels B, Rubenstrunk A, Noel B, Rigou G, Delataille P, Millatt LJ, Baron M, Lucas A, Tailleux A, Hum DW, Ratziu V, Cariou B, Hanf R. Hepatoprotective effects of the dual peroxisome proliferator-activated receptor alpha/delta agonist, GFT505, in rodent models of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Hepatology. 2013 Dec;58(6):1941-52. doi: 10.1002/hep.26461. Epub 2013 Oct 29.
- Derived from this study: PubMed 21816979Cariou B, Zair Y, Staels B, Bruckert E. Effects of the new dual PPAR alpha/delta agonist GFT505 on lipid and glucose homeostasis in abdominally obese patients with combined dyslipidemia or impaired glucose metabolism. Diabetes Care. 2011 Sep;34(9):2008-14. doi: 10.2337/dc11-0093. Epub 2011 Aug 4.
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Enrolling by invitationObservational study
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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.
Rémy Hanf, Development Director study director
GENFIT, France
Eric BRUCKERT, Pr. study chair
University Hospital of Paris 6, France
47 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GFT505 80mg in people with Atherogenic Dyslipidaemia and Abdominal Obesity, run by Genfit at 47 sites in 3 countries.
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 5 inclusion and 3 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 7 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in France, Romania, Tunisia. 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. Some participants in this study may receive a placebo. 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?
Decrease in serum Triglycerides (TG) level (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01271751, which also lists 2 linked publications.
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 7 Jan 2011.