Trials / Completed
CompletedNCT02330549
ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) and Suspected NAFLD
ORION - Effect of CCR2 and CCR5 Antagonism by Cenicriviroc on Peripheral and Adipose Tissue Insulin Sensitivity in Adult Obese Subjects With Prediabetes or Type 2 Diabetes Mellitus and Suspected Non-Alcoholic Fatty Liver Disease (NAFLD)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Tobira Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2015-07-17
- Primary completion
- 2016-08-11
- Completion
- 2016-09-08
- First posted
- 2015-01-05
- Last updated
- 2019-10-11
- Results posted
- 2019-10-11
Locations
3 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02330549. Inclusion in this directory is not an endorsement.