Pilot Study With GFT505 (80mg) in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity.
A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80 mg) Orally Administered Once Daily for 35 Days in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity. A Double Blind, Parallel Group, Placebo-controlled and Randomized Study.
2 other identifiers
interventional
47
1 country
20
Brief Summary
The purpose of this study is to evaluate the efficacy of GFT505 80mg compared with placebo in improving Oral Glucose Tolerance Test (OGTT), in patients with impaired glucose tolerance and abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 35 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2009
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 10, 2011
CompletedFirst Posted
Study publicly available on registry
January 12, 2011
CompletedJanuary 12, 2011
January 1, 2011
6 months
January 10, 2011
January 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oral Glucose test Tolerance (OGTT)
To evaluate the change in plasma Glucose 2hr following oral glucose load from baseline to end point. Evaluation will be made during the selection period, prior any drug intake, and 4 weeks (28-34 days) after the first treatment intake.
4 weeks
Secondary Outcomes (5)
Volume oxygen maximal (VO2max)
5 weeks
Respiratory parameters measured during the physical exercise test
5 weeks
Fasting Glycemia and Insulinemia
5 weeks
HOMA index (Homeostasis Model Assessment)
5 weeks
Lipids
5 weeks
Study Arms (2)
GFT505 80mg
EXPERIMENTALMatching placebo
PLACEBO COMPARATORInterventions
Hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast.
Hard gelatin capsules, oral administration, 4 capsules per day before breakfast.
Eligibility Criteria
You may qualify if:
- Male or post-menopausal female.
- Waist circumference ≥94cm for male, ≥ 80cm for female.
- Fasting Plasma Glucose (FPG) between 110 and 126 mg/dl (between 6.1 and 7.0 mmol/l) within 6 months prior to the screening visit.
- hour glycaemia at OGTT (2hr after a 75g oral glucose load) ≥140 mg/dL (7.8 mmol/l).
You may not qualify if:
- Body Mass Index (BMI) ≥ 40 kg/m².
- Blood Pressure \> 160 / 95 mmHg.
- Known Type I or type II Diabetes Mellitus.
- Glycated haemoglobin (HbA1c) \>7%.
- A fasting TG \> 400mg/dl and a LDL-C \> 220mg/dl.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genfitlead
Study Sites (20)
Site n°31
Angers, 49000, France
Site n°32
Angers, 49000, France
Site n°36
Angers, 49000, France
Site n°37
Angers, 49000, France
Site n°34
Angers, 49100, France
Site n°35
Angers, 49100, France
Site n°39
Angers, 49100, France
Site n°17
Briollay, 49125, France
Site n°16
Cholet, 49300, France
Site n°19
Cholet, 49300, France
Site n°14
Le Mesnil-en-Vallée, 49410, France
Site n°10
Mûrs-Erigné, 49610, France
Site n°12
Mûrs-Erigné, 49610, France
Site n°2
Nantes, 44093, France
Site n°13
Parçay-les-Pins, 49390, France
Site n°1
Paris, 75013, France
Site n°15
Segré, 49500, France
Site n°11
Thouars, 79100, France
Site n°30
Tiercé, 49125, France
Site n°18
Vihiers, 49310, France
Related Publications (2)
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.
PMID: 23703580DERIVEDCariou 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.
PMID: 21816979DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rémy Hanf, Development Director
GENFIT, France
- STUDY CHAIR
Eric BRUCKERT, Pr.
University Hospital of Paris 6, France
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 10, 2011
First Posted
January 12, 2011
Study Start
June 1, 2009
Primary Completion
December 1, 2009
Study Completion
January 1, 2010
Last Updated
January 12, 2011
Record last verified: 2011-01