Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets

NCT07502495 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: COVALENT-211
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 18

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 who are not achieving glycemic targets despite antihyperglycemic medications.

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

  52 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

icovamenib 100 mg QD in addition to their currently prescribed antihyperglycemic medication(s) for 12 weeks. At Week 12, participants will continue on their currently prescribed antihyperglycemic medication(s). The total duration of the trial is approximately 56 weeks

Drug: icovamenib 100mg

Arm B: placebo matching 100 mg

PLACEBO COMPARATOR

placebo matching 100mg QD in addition to their currently prescribed antihyperglycemic medication(s) for 12 weeks. At Week 12, participants will continue on their currently prescribed antihyperglycemic medication(s). The total duration of the trial is approximately 56 weeks

Drug: Placebo

Interventions

icovamenib 100mg DRUG

icovamenib 100mg

Arm A: icovamenib 100 mg

Placebo DRUG

Matching placebo

Arm B: placebo matching 100 mg

Eligibility Criteria

• Age: 18 Years - 75 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 ≤75 years
• Diagnosed with T2D
• Have been treated with lifestyle management with 1 to 3 antihyperglycemic medications: metformin, SGLT2i, alogliptin, or sitagliptin with a stable dose for at least 3 months prior to screening (if participants are taking metformin they must be on a minimum stable dose of ≥500 mg/day)
• Have HbA1c ≥7.5 and ≤10.5%
• Have a BMI ≤32 kg/m2
• Female participants of childbearing potential must have a negative pregnancy test, must be non-lactating, must be willing to have additional pregnancy tests during the study, and must agree to the sex and contraception requirements.
• 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 positive GAD autoantibody result within 60 days 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
• Use of GLP-1 RA, dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, \[linagliptin, saxagliptin (these 2 are drugs within DPP-4i class)\], bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening
• Have fasting triglyceride ≥500 mg/dL
• Have an eGFR \<60 mL/min/1.73 m2 by the CKD-EPI Creatinine Equation at screening
• Have impaired liver function, defined as screening AST or ALT \>1.2×ULN, and/or total bilirubin \>ULN

Sponsors & Collaborators

• Biomea Fusion Inc.: lead

Study Sites (18)

Central Research Associates, LLC dba Flourish Research

Birmingham, Alabama, 35205, United States

Location

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

Ark Clinical Research

Fountain Valley, California, 92708, United States

Location

Ark Clinical Research

Long Beach, California, 90815, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Paradigm Clinical Research Centers, LLC

San Diego, California, 92108, United States

Location

Southwest General Healthcare Center

Fort Myers, Florida, 33907, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, 32789, United States

Location

David Kavtaradze MD, Inc

Cordele, Georgia, 31015, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Diabetes and Endocrinology Associates of Stark County

Canton, Ohio, 44718, United States

Location

Elligo Health Research, Inc.

Austin, Texas, 78704, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

Synergy Groups Medical

Houston, Texas, 77061, United States

Location

Epic Clinical Research

Lewisville, Texas, 75057, United States

Location

Synergy Group Medical LLC

Missouri City, Texas, 77459, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

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 antihyperglycemic medication(s). Treatment with icovamenib or placebo will last for 12 weeks. At Week 12, participants in each treatment arm will continue on their currently prescribed antihyperglycemic medication(s). 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: March 27, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)