Clinical trial NCT01271751: Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal Obesity
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atherogenic Dyslipidaemia
Abdominal Obesity
Keywords: Atherogenic-dyslipidaemia
PPARs
Lead sponsor: Genfit
Sponsor class: INDUSTRY
First posted: 2011-01-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Body Mass Index (BMI) ≥ 40 kg/m².
* Blood Pressure \> 160 / 95 mmHg.
* Type I or type II Diabetes Mellitus.

Primary outcomes:
measure: Decrease in serum Triglycerides (TG) level
timeFrame: 28 days
measure: Increase in serum High Density Lipoprotein Cholesterol (HDL-C) level
timeFrame: 28 days
Secondary outcomes:
measure: Decrease in Low Density Lipoprotein Cholesterol (LDL-C) levels
timeFrame: 28 days
measure: Decrease in non-HDL-C (High Density Lipoprotein Cholesterol) levels
timeFrame: 28 days
Other outcomes:
Locations:
city: Aigrefeuille Sur Maine
country: France
facility: Site n°36
city: Angers
country: France
facility: Site n°78
city: Angers
country: France
facility: Site n°79
city: Angers
country: France
facility: Site n°80
city: Angers
country: France
facility: Site n°82
city: Baune
country: France
facility: Site n°21
city: Beaucouze
country: France
facility: Site n°16
city: Briollay
country: France
facility: Site n°18
city: Cholet
country: France
facility: Site n°14
city: Cholet
country: France
facility: Site n°26
city: Haute Goulaine
country: France
facility: Site n°42
city: Heric
country: France
facility: Site n°45
city: La Chapelle Sur Erdre
country: France
facility: Site n°32
city: La Jubaudière
country: France
facility: Site n°11
city: La Montagne
country: France
facility: Site n°30
city: Laval
country: France
facility: Site n°91
city: Le Mesnil en Vallée
country: France
facility: Site n°23
city: le Temple de Bretagne
country: France
facility: Site n°35
city: Les Ponts de Ce
country: France
facility: Site n°12
city: Montreuil Juigne
country: France
facility: Site n°17
city: Montrevault
country: France
facility: Site n°74
city: Murs-Erigné
country: France
facility: Site n°10
city: Murs-Erigné
country: France
facility: Site n°19
city: Nantes
country: France
facility: Site n°40
city: Nantes
country: France
facility: Site n°37
city: Nantes
country: France
facility: Site n°31
city: Nantes
country: France
facility: Site n°34
city: Nort sur Erdre
country: France
facility: Site n°41
city: Orvault
country: France
facility: Site n°33
city: Paris
country: France
facility: Site n°1
city: Sautron
country: France
facility: Site n°39
city: Segre
country: France
facility: Site n°13
city: St Etienne de Montluc
country: France
facility: Site n°38
city: Tierce
country: France
facility: Site n°75
city: Tierce
country: France
facility: Site n°77
city: Vihiers
country: France
facility: Site n°20
city: Brasov
country: Romania
facility: Site n°64
city: Bucharest
country: Romania
facility: Site n°61
city: Bucharest
country: Romania
facility: Site n°60
city: Bucharest
country: Romania
facility: Site n°63
city: Bucharest
country: Romania
facility: Site n°62
city: Craiova
country: Romania
facility: Site n°65
city: Bab Sâadoun Tunis
country: Tunisia
facility: Site n°52
city: Bab Sâadoun Tunis
country: Tunisia
facility: Site n°53
city: Tunis
country: Tunisia
facility: Site n°50
city: Tunis
country: Tunisia
facility: Site n°51
city: Tunis
country: Tunisia
facility: Site n°55
Study officials:
affiliation: GENFIT, France
name: Rémy Hanf, Development Director
role: STUDY_DIRECTOR
affiliation: University Hospital of Paris 6, France
name: Eric BRUCKERT, Pr.
role: STUDY_CHAIR
References:
citation: 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.
citation: Cariou 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.