Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal Obesity

Abdominal Obesity Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271751
• Other study ID #: GFT505-208-3
• Secondary ID: 2008-005779-86
• Status: Completed
• Phase: Phase 2
• First received: January 6, 2011
• Last updated: January 6, 2011
• Start date: January 2009
• Est. completion date: November 2009

Study information

• Verified date: January 2011
• Source: Genfit
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Romania: Ethics CommitteeRomania: National Medicines AgencyTunisia: Ministry of Public Health
• Study type: Interventional

Clinical 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 administrations of oral doses of GFT505 during 28 days.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Obesity
• Atherogenic Dyslipidaemia
• Dyslipidemias
• Obesity
• Obesity, Abdominal

Intervention

Drug:
• GFT505 80mg
hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast
• Placebo
hard gelatin capsules, oral administration, 4 capsules per day before breakfast

Locations

Country	Name	City	State
France	Site n°36	Aigrefeuille Sur Maine
France	Site n°78	Angers
France	Site n°79	Angers
France	Site n°80	Angers
France	Site n°82	Angers
France	Site n°21	Baune
France	Site n°16	Beaucouze
France	Site n°18	Briollay
France	Site n°14	Cholet
France	Site n°26	Cholet
France	Site n°42	Haute Goulaine
France	Site n°45	Heric
France	Site n°32	La Chapelle Sur Erdre
France	Site n°11	La Jubaudière
France	Site n°30	La Montagne
France	Site n°91	Laval
France	Site n°23	Le Mesnil en Vallée
France	Site n°35	le Temple de Bretagne
France	Site n°12	Les Ponts de Ce
France	Site n°17	Montreuil Juigne
France	Site n°74	Montrevault
France	Site n°10	Murs-Erigné
France	Site n°19	Murs-Erigné
France	Site n°31	Nantes
France	Site n°34	Nantes
France	Site n°37	Nantes
France	Site n°40	Nantes
France	Site n°41	Nort sur Erdre
France	Site n°33	Orvault
France	Site n°1	Paris
France	Site n°39	Sautron
France	Site n°13	Segre
France	Site n°38	St Etienne de Montluc
France	Site n°75	Tierce
France	Site n°77	Tierce
France	Site n°20	Vihiers
Romania	Site n°64	Brasov
Romania	Site n°60	Bucharest
Romania	Site n°61	Bucharest
Romania	Site n°62	Bucharest
Romania	Site n°63	Bucharest
Romania	Site n°65	Craiova
Tunisia	Site n°52	Bab Sâadoun Tunis
Tunisia	Site n°53	Bab Sâadoun Tunis
Tunisia	Site n°50	Tunis
Tunisia	Site n°51	Tunis
Tunisia	Site n°55	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Genfit

Countries where clinical trial is conducted

France,  Romania,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	28 days	No
Primary	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)	28 days	No
Secondary	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)	28 days	No
Secondary	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)	28 days	No