Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT07172867
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Ph2 Study to Evaluate the Safety, Efficacy and Tolerability of HT-6184 and Semaglutide in Obese Participants With T2DM
Sponsor:
Halia Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study to Evaluate the Safety, Efficacy and Tolerability of Ofirnoflast (HT-6184) and Semaglutide in Obese or Overweight Participants With Type 2 Diabetes Mellitus (T2DM)
Status:
RECRUITING
Status Verified Date:
2025-12
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:
The purpose of this study is to evaluate the efficacy and safety of ofirnoflast in combination with semaglutide in comparison to semaglutide alone in obese participants with T2DM.
Detailed Description:
The purpose of this study is to evaluate the efficacy and safety of ofirnoflast in combination with semaglutide in comparison to semaglutide alone in obese participants with T2DM.
This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial.
* The study duration will be up to 28 weeks.
* The screening period will be up to 4 weeks
* The treatment duration will be 12 weeks.
* The follow-up period will be 12 weeks
* The visit frequency will be every 4 weeks during the treatment phase of the study.
* There will be an anticipated 7 scheduled clinic visits, including 1 screening visit and 2 follow-up visits.
This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial.
* The study duration will be up to 28 weeks.
* The screening period will be up to 4 weeks
* The treatment duration will be 12 weeks.
* The follow-up period will be 12 weeks
* The visit frequency will be every 4 weeks during the treatment phase of the study.
* There will be an anticipated 7 scheduled clinic visits, including 1 screening visit and 2 follow-up visits.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: