60 Participants NeededMy employer runs this trial

Icovamenib for Type 2 Diabetes

Recruiting at 16 trial locations
BF
Overseen ByBiomea Fusion Inc.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Biomea Fusion Inc.
Must be taking: Ozempic, Metformin, SGLT2 inhibitors
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new medicine, icovamenib, to determine its effectiveness for people with Type 2 Diabetes who aren't achieving desired results from their current Ozempic treatment. The trial aims to assess whether icovamenib can better control blood sugar levels. Participants will receive either icovamenib or a placebo (a harmless pill resembling the medicine) alongside their usual Ozempic regimen. This trial suits individuals with Type 2 Diabetes who have been taking Ozempic and still experience high blood sugar levels despite other lifestyle changes or medications. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

You can continue taking Ozempic and up to two other diabetes medications like metformin or an SGLT2 inhibitor, as long as you've been on a stable dose for at least 3 months. However, you cannot use other diabetes medications like insulin or sulfonylureas.

Is there any evidence suggesting that icovamenib is likely to be safe for humans?

Research has shown that icovamenib was safe in earlier studies. In one study, participants with Type 2 Diabetes took icovamenib once a day for 12 weeks. The study found ongoing benefits from the treatment without any major safety issues. Some participants experienced mild side effects like nausea or headache, but these were common with many medications and were not serious in the study. Overall, icovamenib appears well-tolerated, making it a promising option for those seeking new diabetes treatments.12345

Why do researchers think this study treatment might be promising for Type 2 Diabetes?

Icovamenib is unique because it introduces a new way to manage Type 2 Diabetes by potentially enhancing the effects of existing medications like Ozempic (semaglutide). Most treatments for Type 2 Diabetes focus on controlling blood sugar levels through insulin modulation or glucose absorption. However, icovamenib works differently by adding a novel mechanism that could improve overall glucose regulation when used alongside Ozempic. Researchers are excited about icovamenib because it might offer a more effective combination approach, potentially leading to better long-term outcomes for people with Type 2 Diabetes.

What evidence suggests that icovamenib might be an effective treatment for Type 2 Diabetes?

Research has shown that icovamenib can help people with Type 2 Diabetes (T2D) better control their blood sugar. In earlier studies, patients taking icovamenib experienced a noticeable drop in their HbA1c levels, a measure of blood sugar over time. For example, one study found that taking 100 mg of icovamenib daily led to an average reduction of 0.36% in HbA1c levels. In this trial, participants in one arm will receive icovamenib 100 mg in addition to their currently prescribed Ozempic (semaglutide injection)-based regimen. Additionally, icovamenib has worked well with semaglutide, another diabetes medication, improving blood sugar control and aiding weight loss in animal studies. These findings suggest that icovamenib could be a promising option for those not meeting their blood sugar goals with current treatments.12367

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with type 2 diabetes who are not meeting blood sugar goals despite taking Ozempic (at least 0.5 mg/week) and possibly metformin or SGLT2 inhibitors, have a BMI between 25-40, and stable medication doses. People with certain diabetes complications or other types of diabetes cannot join.

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.
See 6 more

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.
See 3 more

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

Trial Overview

The study compares icovamenib (100 mg) to a placebo in people with type 2 diabetes already on GLP-1 therapy like Ozempic. Participants are randomly assigned to either group without knowing which one they receive.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A: icovamenib 100 mgExperimental Treatment1 Intervention
Group II: Arm B: matching placebo 100 mgPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Biomea Fusion Inc.

Lead Sponsor

Trials
5
Recruited
780+

Citations

Biomea Fusion Announces Positive 52-Week Results from ...

In patients diagnosed within 0-3 years, treatment with icovamenib 200 mg once daily for 12 weeks resulted in a 52% increase in mean C-peptide ...

272-OR: COVALENT-111: 26-Week Efficacy and Safety after 8 ...

Conclusion: Icovamenib for 8 or 12 wks resulted in significant improvements in A1C at 26 wks in poorly controlled T2D. As expected, based on ...

NCT07502508 | Phase 2 Trial of Icovamenib in Participants ...

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) ...

Insights from COVALENT-111 Case Studies

Case 2: 29-year-old male, 4-year T2D history. Received 200mg icovamenib daily. HbA1c decreased from 9.5% (baseline) to 7.0% (Week 26) and then declined to 5.8% ...

COVALENT-111 Phase II Study Icovamenib in Type 2 Diabetes

This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth ...

Biomea Fusion Announces Positive 52-Week Results from ...

Icovamenib showed a sustained treatment benefit at Week 52 (9 months past the end of treatment) in the severe insulin-deficient diabetes ...

Oral drug cuts HbA1c, improves C-peptide in type 2 diabetes

Once-daily oral icovamenib was associated with HbA1c reductions that were maintained at 1 year. Adults receiving icovamenib in two of the ...