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

Sponsor
Halia Therapeutics, Inc.
Study ID
NCT07172867
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • HT-6184 — DRUG
    2mg QD
  • HT-6184 Matching Placebo — DRUG
    2mg QD
  • Semaglutide 1 mg — DRUG
    Semaglutide 1 mg, every week

Study Details

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.

Key Dates

Start date
Jan 6, 2026
Status verified
Feb 2026
Primary completion
Jan 23, 2026
Completion
Jan 23, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HT-6184 2mg Treatment
    Ofirnoflast (2 mg): dosed once a day, orally (PO QD) + semaglutide (1 mg): dosed weekly (q1wk), via subcutaneous (SC) injection for 12 weeks.
  • Placebo Comparator: HT-6184 2mg Matching Placebo
    Placebo: dosed once a day, orally (PO QD) + semaglutide (1 mg): dosed weekly (q1wk), via SC injection for 12 weeks.

Primary Outcome Measure

Assess glycemic control using HbA1c (%) [ Time Frame: From first dose through End of Study (up to 12 weeks per participant) ]

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