NCT07172867

A Ph2 Study to Evaluate the Safety, Efficacy and Tolerability of HT-6184 and Semaglutide in Obese Participants With T2DM

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• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Halia Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2
• Obesity

Interventions

Type	Name	Description
DRUG	HT-6184	2mg QD
DRUG	HT-6184 Matching Placebo	2mg QD
DRUG	Semaglutide 1 mg	Semaglutide 1 mg, every week

Timeline

• Start date: 2026-01-06
• Primary completion: 2026-01-23
• Completion: 2026-01-23
• First posted: 2025-09-15
• Last updated: 2026-02-25

Locations

1 site across 1 country: United Arab Emirates