ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) and Suspected NAFLD

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.

Timeline

Start

2015-07-17

Primary completion

2016-08-11

Completion

2016-09-08

Outcome

Missed primary endpoint

registry analysis (other test); Cenicriviroc 150 mg vs Placebo; p = 0.2483; LS Mean Difference -0.2286 (95% CI -0.62 to 0.17); ANCOVA; NCT02330549 ↗

registry analysis (other test); Cenicriviroc 150 mg vs Placebo; p = 0.5297; LS Mean Difference -1.505 (95% CI -6.33 to 3.32); ANCOVA; NCT02330549 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cenicriviroc	Small molecule	150 mg	Oral

Indications