Icovamenib for Type 2 Diabetes

Recruiting at 13 trial locations

Overseen By Biomea Fusion Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biomea Fusion Inc.

Must be taking: Ozempic, Metformin, SGLT2 inhibitors

Must not be taking: Sulfonylureas, Insulin, others

Disqualifiers: Type 1 diabetes, Severe hypoglycemia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I take at least 0.5 mg of Ozempic per week on a stable dose.

BMI 25 to 40 kg/m2

I am between 18 and 70 years old.

Exclusion Criteria

I have not had diabetic ketoacidosis or a hyperosmolar coma in the past 6 months.

I have type 1 diabetes or another form of secondary diabetes.

I have had severe low blood sugar or trouble noticing low blood sugar symptoms recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive icovamenib 100 mg or matching placebo daily for 12 weeks in addition to their Ozempic-based regimen

12 weeks

Follow-up

Participants continue on a stable dose of their baseline Ozempic-based regimen and are monitored for safety and effectiveness

42 weeks

What Are the Treatments Tested in This Trial?

Interventions

• icovamenib

How Is the Trial Designed?

Group I: Arm A: icovamenib 100 mg Experimental Treatment 1 Intervention

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)

Group II: Arm B: matching placebo 100 mg Placebo Group 1 Intervention

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).

Who Is Running the Clinical Trial?

Biomea Fusion Inc.

Lead Sponsor

Trials

5

Recruited

780+