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

NCT07502508 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: COVALENT-212
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control

  12 weeks

• To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control

  52 weeks

• To compare the change in fasting plasma glucose with icovamenib versus placebo during the off-treatment Follow-up Period

  26 weeks

• To compare the safety and tolerability of icovamenib versus placebo

  52 weeks

• To compare the safety and tolerability of icovamenib versus placebo

  16 weeks

Other Outcomes (2)

• To characterize the pharmacokinetics of icovamenib

  10 weeks

• To characterize the pharmacokinetics of icovamenib

  10 weeks

Study Arms (2)

Arm A: icovamenib 100 mg

EXPERIMENTAL

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

Arm B: matching placebo 100 mg

PLACEBO COMPARATOR

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

Interventions

icovamenib 100 mg DRUG

icovamenib 100 mg

Arm A: icovamenib 100 mg

Placebo DRUG

Matching placebo

Arm B: matching placebo 100 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, age ≥18 years and ≤70 years
• Have been diagnosed with T2D
• 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
• Have HbA1c ≥7.5 and ≤9.5%
• Have a BMI 25 to 40 kg/m2
• 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.

You may not qualify if:

• Have type 1 diabetes mellitus or a secondary form of diabetes
• Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening
• 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
• Have personal or family history (first-degree relative) of MEN1 or MEN2 or medullary thyroid carcinoma
• 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
• Have FPG ≥240 mg/dL

Sponsors & Collaborators

• Biomea Fusion Inc.: lead

Study Sites (16)

Central Research Associates, LLC dba Flourish Research

Birmingham, Alabama, 35205, United States

RECRUITING

Hope Clinical Research

Canoga Park, California, 91303, United States

RECRUITING

Ark Clinical Research

Long Beach, California, 90815, United States

RECRUITING

Catalina Research Institute, LLC

Montclair, California, 91763, United States

RECRUITING

Paradigm Clinical Research Centers, LLC

San Diego, California, 92108, United States

RECRUITING

Southwest General Healthcare Center

Fort Myers, Florida, 33907, United States

RECRUITING

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

RECRUITING

David Kavtaradze MD, Inc

Cordele, Georgia, 31015, United States

RECRUITING

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

RECRUITING

Diabetes and Endocrinology Associates of Stark County

Canton, Ohio, 44718, United States

RECRUITING

Elligo Health Research, Inc.

Austin, Texas, 78704, United States

RECRUITING

Zenos Clinical Research

Dallas, Texas, 75230, United States

RECRUITING

Synergy Group Medical

Houston, Texas, 77061, United States

RECRUITING

Epic Clinical Research

Lewisville, Texas, 75057, United States

RECRUITING

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, 78229, United States

RECRUITING

Burke Internal Medicine and Research

Burke, Virginia, 22015, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Biomea Fusion Inc.

CONTACT

8442450490; clinicaltrials@biomeafusion.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study uses a randomized, double-blind, placebo-controlled design with parallel assignment between 2 treatments. The trial begins with a screening period of up to 28 days. Eligible participants will be randomly assigned to 1 of 2 treatment arms using a 2:1 ratio (active to placebo). Starting on Day 1, participants will receive icovamenib 100 mg or placebo in addition to their currently prescribed Ozempic (semaglutide injection)-based regimen. Treatment with icovamenib or placebo will last for 12 weeks. At Week 12, participants in each treatment arm 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).

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: March 31, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)