--- title: Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal Obesity nct_id: NCT01271751 overall_status: COMPLETED phase: PHASE2 sponsor: Genfit study_type: INTERVENTIONAL primary_condition: Atherogenic Dyslipidaemia countries: France, Romania, Tunisia canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01271751.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01271751" ct_last_update_post_date: 2011-01-07 last_seen_at: "2026-05-12T06:24:06.585Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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. **NCT ID:** [NCT01271751](https://clinicaltrials.gov/study/NCT01271751) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 96 - **Lead Sponsor:** Genfit - **Conditions:** Atherogenic Dyslipidaemia, Abdominal Obesity - **Start Date:** 2009-01 - **Completion Date:** 2009-11 - **CT.gov Last Update:** 2011-01-07 ## 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 - **Minimum age:** 18 Years - **Maximum age:** 75 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **GFT505 80mg** (EXPERIMENTAL) - **Matching placebo** (PLACEBO_COMPARATOR) ## Interventions - **GFT505 80mg** (DRUG) — hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast - **Placebo** (DRUG) — hard gelatin capsules, oral administration, 4 capsules per day before breakfast ## Primary Outcomes - **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) ## 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)_ ## Locations (47) - 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, Bauné, France - Site n°16, Beaucouzé, 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, Héric, 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-Cé, France - Site n°17, Montreuil-Juigné, France - Site n°74, Montrevault, France - Site n°10, Murs-Erigné, France - Site n°19, Murs-Erigné, France - Site n°40, Nantes, France - Site n°37, Nantes, France - Site n°31, Nantes, France - Site n°34, Nantes, France - Site n°41, Nort-sur-Erdre, France - Site n°33, Orvault, France - Site n°1, Paris, France - Site n°38, Saint-Étienne-de-Montluc, France - Site n°39, Sautron, France - Site n°13, Segré, France - Site n°75, Tiercé, France - Site n°77, Tiercé, France - Site n°20, Vihiers, France - Site n°64, Brasov, Romania - Site n°61, Bucharest, Romania - Site n°60, Bucharest, Romania - Site n°63, Bucharest, Romania - Site n°62, Bucharest, Romania - Site n°65, Craiova, Romania - 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, Tunisia ## Recent Field Changes (last 30 days) - `outcomes.secondary` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.site n°36|aigrefeuille-sur-maine||france` — added _(2026-05-12)_ - `locations.site n°78|angers||france` — added _(2026-05-12)_ - `locations.site n°79|angers||france` — added _(2026-05-12)_ - `locations.site n°80|angers||france` — added _(2026-05-12)_ - `locations.site n°82|angers||france` — added _(2026-05-12)_ - `locations.site n°21|bauné||france` — added _(2026-05-12)_ - `locations.site n°16|beaucouzé||france` — added _(2026-05-12)_ - `locations.site n°18|briollay||france` — added _(2026-05-12)_ - `locations.site n°14|cholet||france` — added _(2026-05-12)_ - `locations.site n°26|cholet||france` — added _(2026-05-12)_ - `locations.site n°42|haute-goulaine||france` — added _(2026-05-12)_ - `locations.site n°45|héric||france` — added _(2026-05-12)_ - `locations.site n°32|la chapelle-sur-erdre||france` — added _(2026-05-12)_ - `locations.site n°11|la jubaudière||france` — added _(2026-05-12)_ - `locations.site n°30|la montagne||france` — added _(2026-05-12)_ - `locations.site n°91|laval||france` — added _(2026-05-12)_ - `locations.site n°23|le mesnil-en-vallée||france` — added _(2026-05-12)_ - `locations.site n°35|le temple-de-bretagne||france` — added _(2026-05-12)_ - `locations.site n°12|les ponts-de-cé||france` — added _(2026-05-12)_ - `locations.site n°17|montreuil-juigné||france` — added _(2026-05-12)_ - `locations.site n°74|montrevault||france` — added _(2026-05-12)_ - `locations.site n°10|murs-erigné||france` — added _(2026-05-12)_ - `locations.site n°19|murs-erigné||france` — added _(2026-05-12)_ - `locations.site n°40|nantes||france` — added _(2026-05-12)_ - `locations.site n°37|nantes||france` — added _(2026-05-12)_ - `locations.site n°31|nantes||france` — added _(2026-05-12)_ - `locations.site n°34|nantes||france` — added _(2026-05-12)_ - `locations.site n°41|nort-sur-erdre||france` — added _(2026-05-12)_ - `locations.site n°33|orvault||france` — added _(2026-05-12)_ - `locations.site n°1|paris||france` — added _(2026-05-12)_ - `locations.site n°38|saint-étienne-de-montluc||france` — added _(2026-05-12)_ - `locations.site n°39|sautron||france` — added _(2026-05-12)_ - `locations.site n°13|segré||france` — added _(2026-05-12)_ - `locations.site n°75|tiercé||france` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01271751.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01271751* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*