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

Sponsor

Genfit (Industry)

Overall Status

Completed

CT.gov ID

NCT01271751

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherogenic Dyslipidaemia Abdominal Obesity	Drug: GFT505 80mg Drug: Placebo	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GFT505 80mg	Drug: GFT505 80mg hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast
Placebo Comparator: Matching placebo	Drug: Placebo hard gelatin capsules, oral administration, 4 capsules per day before breakfast

Arm

Intervention/Treatment

Experimental: GFT505 80mg

Drug: GFT505 80mg

hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast

Placebo Comparator: Matching placebo

Drug: Placebo

hard gelatin capsules, oral administration, 4 capsules per day before breakfast

Outcome Measures

Primary Outcome Measures

Decrease in serum Triglycerides (TG) level [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 [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)

Secondary Outcome Measures

Decrease in Low Density Lipoprotein Cholesterol (LDL-C) levels [28 days]
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)
Decrease in non-HDL-C (High Density Lipoprotein Cholesterol) levels [28 days]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Site n°36	Aigrefeuille Sur Maine	France	44140
2	Site n°78	Angers	France	49000
3	Site n°79	Angers	France	49000
4	Site n°80	Angers	France	49000
5	Site n°82	Angers	France	49000
6	Site n°21	Baune	France	49140
7	Site n°16	Beaucouze	France	49070
8	Site n°18	Briollay	France	49125
9	Site n°14	Cholet	France	49300
10	Site n°26	Cholet	France	49300
11	Site n°42	Haute Goulaine	France	44115
12	Site n°45	Heric	France	44810
13	Site n°32	La Chapelle Sur Erdre	France	44240
14	Site n°11	La Jubaudière	France	49510
15	Site n°30	La Montagne	France	44620
16	Site n°91	Laval	France	53000
17	Site n°23	Le Mesnil en Vallée	France	49410
18	Site n°35	le Temple de Bretagne	France	44360
19	Site n°12	Les Ponts de Ce	France	49130
20	Site n°17	Montreuil Juigne	France	49460
21	Site n°74	Montrevault	France	49110
22	Site n°10	Murs-Erigné	France	49610
23	Site n°19	Murs-Erigné	France	49610
24	Site n°40	Nantes	France	44000
25	Site n°37	Nantes	France	44100
26	Site n°31	Nantes	France	44300
27	Site n°34	Nantes	France	44300
28	Site n°41	Nort sur Erdre	France	44390
29	Site n°33	Orvault	France	44700
30	Site n°1	Paris	France	75013
31	Site n°39	Sautron	France	44880
32	Site n°13	Segre	France	49500
33	Site n°38	St Etienne de Montluc	France	44360
34	Site n°75	Tierce	France	49125
35	Site n°77	Tierce	France	49125
36	Site n°20	Vihiers	France	49310
37	Site n°64	Brasov	Romania
38	Site n°61	Bucharest	Romania	010243
39	Site n°60	Bucharest	Romania	Sector 2
40	Site n°63	Bucharest	Romania	Sector 2
41	Site n°62	Bucharest	Romania
42	Site n°65	Craiova	Romania
43	Site n°52	Bab Sâadoun Tunis	Tunisia	1029
44	Site n°53	Bab Sâadoun Tunis	Tunisia	1029
45	Site n°50	Tunis	Tunisia	1007
46	Site n°51	Tunis	Tunisia	1007
47	Site n°55	Tunis	Tunisia	1089