Ignite Creation Date:
2024-05-06 @ 3:37 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02330549
Status:
COMPLETED
Last Update Posted:
2019-10-11
First Post:
2014-12-22
Brief Title:
ORION Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus T2DM and Suspected NAFLD
Sponsor:
Tobira Therapeutics Inc
Organization:
Tobira Therapeutics Inc
Study Overview
Official Title:
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
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 kgm2 with prediabetes or type 2 diabetes mellitus and suspected NALFD
Detailed Description:
Approximately 50 adult obese subjects BMI 30 kgm2 with prediabetes or type 2 diabetes mellitus and suspected NALFD will be randomized into the study
Eligible subjects will receive either CVC n25 or matching placebo n25 once daily QD for 24 weeks followed by a safety follow-up visit 4 weeks after last intake of study medication
Eligible subjects will receive either CVC n25 or matching placebo n25 once daily QD for 24 weeks followed by a safety follow-up visit 4 weeks after last intake of study medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None