Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Biomea Fusion Inc.
Study ID
NCT07502508
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • icovamenib 100 mg — DRUG
    icovamenib 100 mg
  • Placebo — DRUG
    Matching placebo

Study Details

This is a phase 2 randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes (T2D) not achieving glycemic targets despite Ozempic-based therapy.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: icovamenib 100 mg
    Starting on Day 1, participants will receive icovamenib 100 mg QD in addition to their currently prescribed Ozempic (semaglutide injection)-based regimen. Treatment will last for 12 weeks. At Week 12, participants will continue on a stable dose of their baseline Ozempic-based regimen. The total duration of the trial is approximately 56 weeks (including screening and follow-up)
  • Placebo Comparator: Arm B: matching placebo 100 mg
    Starting on Day 1, participants will receive icovamenib 100 mg matching placebo QD in addition to their currently prescribed Ozempic (semaglutide injection)-based regimen. Treatment will last for 12 weeks. At Week 12, participants will continue on a stable dose of their baseline Ozempic-based regimen. The total duration of the trial is approximately 56 weeks (including screening and follow-up).

Primary Outcome Measure

To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control [ Time Frame: 26 weeks ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Central Research Associates, LLC dba Flourish ResearchBirminghamAlabama35205-
Hope Clinical ResearchCanoga ParkCalifornia91303-
Ark Clinical ResearchLong BeachCalifornia90815-
Catalina Research Institute, LLCMontclairCalifornia91763-
Paradigm Clinical Research Centers, LLCSan DiegoCalifornia92108-
Southwest General Healthcare CenterFort MyersFlorida33907-
Panax Clinical ResearchMiami LakesFlorida33014-
David Kavtaradze MD, IncCordeleGeorgia31015-
Excel Clinical ResearchLas VegasNevada89109-
Diabetes and Endocrinology Associates of Stark CountyCantonOhio44718-
Elligo Health Research, Inc.AustinTexas78704-
Zenos Clinical ResearchDallasTexas75230-
Synergy Group MedicalHoustonTexas77061-
Epic Clinical ResearchLewisvilleTexas75057-
Diabetes & Glandular Disease Clinic, P.A.San AntonioTexas78229-
Burke Internal Medicine and ResearchBurkeVirginia22015-

Find similar trials in Birmingham, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Central Research Associates, LLC dba Flourish Research· Birmingham, ALHope Clinical Research· Canoga Park, CAArk Clinical Research· Long Beach, CACatalina Research Institute, LLC· Montclair, CAParadigm Clinical Research Centers, LLC· San Diego, CASouthwest General Healthcare Center· Fort Myers, FL

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