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

August 26, 2026 updated by: Biomea Fusion Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a 52-week, Phase 2 trial is designed to examine whether treatment with icovamenib in participants with T2D who are currently on standard-of-care antihyperglycemic medications (metformin, SGLT2 inhibitor, alogliptin, or sitagliptin) plus lifestyle management will result in a greater reduction in HbA1c than those therapies alone. The trial investigates participants who have been on a stable dose of their antihyperglycemic medication(s) for at least 3 months prior to screening whose HbA1c remains above the target established by the American Diabetes Association (ADA).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Central Research Associates, LLC dba Flourish Research
    • California
      • Canoga Park, California, United States, 91303
        • Hope Clinical Research
      • Fountain Valley, California, United States, 92708
        • Ark Clinical Research
      • Long Beach, California, United States, 90815
        • Ark Clinical Research
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
      • San Diego, California, United States, 92108
        • Paradigm Clinical Research Centers, LLC
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Southwest General Healthcare Center
      • Miami Lakes, Florida, United States, 33014
        • Panax Clinical Research
      • Winter Park, Florida, United States, 32789
        • Clinical Site Partners, LLC dba Flourish Research
    • Georgia
      • Cordele, Georgia, United States, 31015
        • David Kavtaradze MD, Inc
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research
    • Ohio
      • Canton, Ohio, United States, 44718
        • Diabetes and Endocrinology Associates of Stark County
    • Texas
      • Austin, Texas, United States, 78704
        • Elligo Health Research, Inc.
      • Dallas, Texas, United States, 75230
        • Zenos Clinical Research
      • Houston, Texas, United States, 77061
        • Synergy Groups Medical
      • Lewisville, Texas, United States, 75057
        • Epic Clinical Research
      • Missouri City, Texas, United States, 77459
        • Synergy Group Medical LLC
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Males or females, age ≥18 years and ≤75 years
  2. Diagnosed with T2D
  3. 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)
  4. Have HbA1c ≥7.5 and ≤10.5%
  5. Have a BMI ≤32 kg/m2
  6. 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.
  7. Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.

Key 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 positive GAD autoantibody result within 60 days prior to screening
  4. 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
  5. Have personal or family history (first-degree relative) of MEN1
  6. 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
  7. Have fasting triglyceride ≥500 mg/dL
  8. Have an eGFR <60 mL/min/1.73 m2 by the CKD-EPI Creatinine Equation at screening
  9. Have impaired liver function, defined as screening AST or ALT >1.2×ULN, and/or total bilirubin >ULN

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: icovamenib 100 mg

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
icovamenib 100mg
Placebo Comparator: Arm B: placebo matching 100 mg

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
Matching placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
Time Frame: 26 weeks
Mean change in HbA1c from baseline
26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
Time Frame: 12 weeks
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
Time Frame: 52 weeks
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
Time Frame: 26 weeks
Mean change in fasting plasma glucose from baseline
26 weeks
To compare the safety and tolerability of icovamenib versus placebo
Time Frame: 52 weeks
Incidence of AEs
52 weeks
To compare the safety and tolerability of icovamenib versus placebo
Time Frame: 52 weeks
Incidence of SAEs
52 weeks
To compare the safety and tolerability of icovamenib versus placebo
Time Frame: 12 weeks
Incidence of early discontinuation of trial intervention due to TEAEs
12 weeks
To compare the safety and tolerability of icovamenib versus placebo
Time Frame: 52 weeks
Incidence of TEAEs
52 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To characterize the pharmacokinetics of icovamenib
Time Frame: 10 weeks
Population pharmacokinetics modeling (AUC)
10 weeks
To characterize the pharmacokinetics of icovamenib
Time Frame: 10 weeks
Population pharmacokinetics modeling (Cmax)
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biomea Fusion Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COVALENT-211

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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