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New diabetes pill icovamenib enters Mid-Stage trial

NCT ID NCT07502495

Disease control Sponsor: Biomea Fusion Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This Phase 2 trial tests whether a new drug called icovamenib can help people with type 2 diabetes who still have high blood sugar despite taking other medications. About 60 adults aged 18 to 70 will receive either icovamenib or a placebo daily for 12 weeks. The main goal is to see if icovamenib lowers HbA1c, a key blood sugar measure, better than placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
icovamenib
What this could lead to
If it works, this could offer a new daily pill option for people with type 2 diabetes to better control their blood sugar.
What could go wrong
This is an early Phase 2 trial with only 60 participants, so results may not apply to everyone. The drug may not work better than placebo or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

64 people

The number who actually took part.

Started

Mar 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes

Contacts and locations

Locations

  • Ark Clinical Research

    Fountain Valley, California, 92708, United States

  • Ark Clinical Research

    Long Beach, California, 90815, United States

  • Catalina Research Institute, LLC

    Montclair, California, 91763, United States

  • Central Research Associates, LLC dba Flourish Research

    Birmingham, Alabama, 35205, United States

  • Clinical Site Partners, LLC dba Flourish Research

    Winter Park, Florida, 32789, United States

  • David Kavtaradze MD, Inc

    Cordele, Georgia, 31015, United States

  • Diabetes and Endocrinology Associates of Stark County

    Canton, Ohio, 44718, United States

  • Elligo Health Research, Inc.

    Austin, Texas, 78704, United States

  • Epic Clinical Research

    Lewisville, Texas, 75057, United States

  • Excel Clinical Research

    Las Vegas, Nevada, 89109, United States

  • Hope Clinical Research

    Canoga Park, California, 91303, United States

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • Panax Clinical Research

    Miami Lakes, Florida, 33014, United States

  • Paradigm Clinical Research Centers, LLC

    San Diego, California, 92108, United States

  • Southwest General Healthcare Center

    Fort Myers, Florida, 33907, United States

  • Synergy Group Medical LLC

    Missouri City, Texas, 77459, United States

  • Synergy Groups Medical

    Houston, Texas, 77061, United States

  • Zenos Clinical Research

    Dallas, Texas, 75230, United States

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