Conditions: Prediabetic State Non-alcoholic Fatty Liver Disease Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 45
Healthy volunteers: no

Brief summary:
A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study of cenicriviroc (CVC) to be conducted in approximately 50 adult obese subjects \[body mass index (BMI) ≥ 30 kg/m\^2\] with prediabetes or type 2 diabetes mellitus and suspected NALFD.

Detailed description:
Approximately 50 adult obese subjects (BMI ≥ 30 kg/m2) with prediabetes or type 2 diabetes mellitus and suspected NALFD will be randomized into the study.

Eligible subjects will receive either CVC (n=25) or matching placebo (n=25), once daily (QD) for 24 weeks, followed by a safety follow-up visit 4 weeks after last intake of study medication.

Arms:
arm 1: Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks. arm 2: Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.

Interventions: intervention 1: Cenicriviroc 150 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food. intervention 2: Placebo-matching CVC administered orally once daily and taken every morning with food.

Protocol document: