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

Phase 2 Randomized, Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Icovamenib in Participants With Type 2 Diabetes Not Achieving Glycemic Targets Despite GLP-1-Based Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Placebo; Drug: icovamenib 100 mg

Detailed Description

This study is a 52-week, phase 2 trial designed to examine whether treatment with icovamenib in participants with T2D who are currently on an Ozempic-based therapy will result in a greater reduction in HbA1c than Ozempic-based therapy alone. The current trial investigates participants who have used Ozempic for at least 3 months prior to screening whose HbA1c remains above the target established by the ADA.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Biomea Fusion Inc.; Phone Number: 8442450490; Email: clinicaltrials@biomeafusion.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Recruiting
      • Central Research Associates, LLC dba Flourish Research
  • California
    • Canoga Park, California, United States, 91303
      • Recruiting
      • HOPE Clinical Research
    • Long Beach, California, United States, 90815
      • Recruiting
      • Ark Clinical Research
    • Montclair, California, United States, 91763
      • Recruiting
      • Catalina Research Institute, LLC
    • San Diego, California, United States, 92108
      • Recruiting
      • Paradigm Clinical Research Centers, LLC
  • Florida
    • Fort Myers, Florida, United States, 33907
      • Recruiting
      • Southwest General Healthcare Center
    • Miami Lakes, Florida, United States, 33014
      • Recruiting
      • Panax Clinical Research
  • Georgia
    • Cordele, Georgia, United States, 31015
      • Recruiting
      • David Kavtaradze MD, Inc
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Recruiting
      • Excel Clinical Research
  • Ohio
    • Canton, Ohio, United States, 44718
      • Recruiting
      • Diabetes and Endocrinology Associates of Stark County
  • Texas
    • Austin, Texas, United States, 78704
      • Recruiting
      • Elligo Health Research, Inc.
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Zenos Clinical Research
    • Houston, Texas, United States, 77061
      • Recruiting
      • Synergy Group Medical
    • Lewisville, Texas, United States, 75057
      • Recruiting
      • EPIC Clinical Research
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Diabetes & Glandular Disease Clinic, P.A.
  • Virginia
    • Burke, Virginia, United States, 22015
      • Recruiting
      • Burke Internal Medicine and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males or females, age ≥18 years and ≤70 years
2. Have been diagnosed with T2D

3. Taking Ozempic (semaglutide injection) and have been treated with lifestyle management and 0 to 2 additional antihyperglycemic medications (metformin and/or SGLT2 inhibitor) with a stable dose of all medications for at least 3 months prior to screening

   • Participants taking metformin must be on a minimum stable dose of ≥500 mg/day
   • Participants taking Ozempic must be on a minimum stable dose of ≥0.5 mg/week
4. Have HbA1c ≥7.5 and ≤9.5%
5. Have a BMI 25 to 40 kg/m2
6. Female participants of childbearing potential must have a negative pregnancy test, must be non-lactating and must be willing to have additional pregnancy tests during the study.7. Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.

Exclusion Criteria:

1. Have type 1 diabetes mellitus or a secondary form of diabetes
2. Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening
3. Have a history of severe hypoglycemia (defined by the occurrence of hypoglycemia symptoms requiring the assistance of another person for recovery) in the 6 months prior to screening or a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms as judged by the investigator
4. Have personal or family history (first-degree relative) of MEN1 or MEN2 or medullary thyroid carcinoma
5. Use of GLP-1 RA other than Ozempic (semaglutide injection), dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, DPP4I, bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening
6. Have FPG ≥240 mg/dL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Drug: icovamenib 100 mg; icovamenib 100 mg
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).	Drug: Placebo; Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control	Mean change in HbA1c from baseline	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control	Mean change in HbA1c from baseline	12 weeks
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control	Mean change in HbA1c from baseline	52 weeks
To compare the change in fasting plasma glucose with icovamenib versus placebo during the off-treatment Follow-up Period	Mean change in fasting plasma glucose from baseline	26 weeks
To compare the safety and tolerability of icovamenib versus placebo	Incidence of AEs	52 weeks
To compare the safety and tolerability of icovamenib versus placebo	Incidence of TEAEs	16 weeks
To compare the safety and tolerability of icovamenib versus placebo	Incidence of SAEs	52 weeks
To compare the safety and tolerability of icovamenib versus placebo	Incidence of early discontinuation of trial intervention due to TEAEs	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To characterize the pharmacokinetics of icovamenib	Population pharmacokinetics modeling (AUC)	10 weeks
To characterize the pharmacokinetics of icovamenib	Population pharmacokinetics modeling (Cmax)	10 weeks

Collaborators and Investigators

• Sponsor: Biomea Fusion Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Type 2 Diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: COVALENT-212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No