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

NCT02330549 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-10-11

Study results available
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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.

Conditions

Interventions

DRUG

Cenicriviroc 150 mg

Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food.

DRUG

Placebo

Placebo-matching CVC administered orally once daily and taken every morning with food.

Sponsors & Collaborators

  • Tobira Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Lefebvre, MD · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-17
Primary Completion
2016-08-11
Completion
2016-09-08
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02330549 on ClinicalTrials.gov