Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicentre, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GFT505 Once Daily on Steatohepatitis in Patients With Non-Alcoholic Steatohepatitis (NASH).
Brief Summary: Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis and possibly lead to cirrhosis and liver cancer. NAFLD (Non Alcoholic Fatty Liver Disease) is considered as the most common form of chronic liver disease in adults in the United States, Australia, Asia and Europe. In the USA, the estimated prevalence of NAFLD is 20-30% of the adult population.

Non-alcoholic Steatohepatitis (NASH) is a progressing form of NAFLD, which corresponds to hepatic steatosis associated with inflammation and liver cell injury upon microscopic examination of a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and deserves serious medical management. Up to now, there is no effective drug which has clearly demonstrated therapeutic efficacy which may help lifestyle and dietary recommendations in the resolution of NASH.

In this context, GENFIT is developing a new liver targeted drug candidate, GFT505, for the treatment of NASH and the reduction of multiple cardiometabolic risk factors associated with the metabolic syndrome and type 2 Diabetes.

This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once daily for 52 weeks on the reversal of NASH without worsening of fibrosis, based on liver biopsy assessments.


Options:
A: Arm Label: Lifestyle intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Life style intervention | Arm Label: Life style intervention, pioglitazone; Type: EXPERIMENTAL; Interventions: Behavioral: Life style intervention, Drug: pioglitazone | Arm Label: Life style intervention, berberine; Type: EXPERIMENTAL; Interventions: Behavioral: Life style intervention, Drug: berberine | Intervention Type: BEHAVIORAL; Name: Life style intervention; Assigned to Arm(s): Life style intervention, berberine, Life style intervention, pioglitazone, Lifestyle intervention | Intervention Type: DRUG; Name: pioglitazone; Assigned to Arm(s): Life style intervention, pioglitazone | Intervention Type: DRUG; Name: berberine; Assigned to Arm(s): Life style intervention, berberine
B: Arm Label: GFT505 80mg; Type: EXPERIMENTAL; Interventions: Drug: GFT505 80mg | Arm Label: GFT505 120mg; Type: EXPERIMENTAL; Interventions: Drug: GFT505 120mg | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: GFT505 80mg; Assigned to Arm(s): GFT505 80mg | Intervention Type: DRUG; Name: GFT505 120mg; Assigned to Arm(s): GFT505 120mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Pioglitazone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pioglitazone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Pioglitazone; Assigned to Arm(s): Pioglitazone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: MRI(+ve),; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: 200mg of Palm vitamin E (tocotrienols) or placebo | Arm Label: MRI(-ve); Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: 200mg of Palm vitamin E (tocotrienols) or placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: 200mg of Palm vitamin E (tocotrienols) or placebo; Assigned to Arm(s): MRI(+ve),, MRI(-ve)

Answer: B