Phase 2 Type 2 Diabetes Trial, Recruiting NCT07502495 Sponsor: Biomea Fusion Inc. Condition: Type 2 Diabetes
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Phase 2 Type 2 Diabetes Trial, Recruiting

NCT07502495
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 70 years (male or female)
  • People who have been diagnosed with type 2 diabetes
  • People who have been managing their diabetes with lifestyle changes and between 1 and 3 blood sugar-lowering medications — specifically metformin (at a dose of at least 500 mg per day), an SGLT2 inhibitor, alogliptin, or sitagliptin — at a stable dose for at least 3 months before the screening visit
  • People whose HbA1c blood sugar level (a measure of average blood sugar over roughly 3 months) is between 7.5% and 10.5%
  • People with a body mass index (BMI) of 32 or below
  • Women who could become pregnant must have a negative pregnancy test at the start, must not be breastfeeding, and must agree to additional pregnancy tests during the study
  • People who are willing and able to give written consent and follow all study procedures and tests

Who may not be able to join:

  • People who have type 1 diabetes or a form of diabetes caused by another condition
  • People who have had diabetic ketoacidosis or a dangerous high-blood-sugar crisis (hyperosmolar coma) in the 6 months before screening
  • People who test positive for GAD autoantibodies at screening (a blood test result linked to certain types of diabetes)
  • People who have had a severe low blood sugar episode requiring another person's help to recover, in the 6 months before screening, or who have difficulty recognising the warning signs of low blood sugar
  • People with a personal or family history (in a parent, sibling, or child) of a condition called MEN1 (multiple endocrine neoplasia type 1)
  • People who have used certain diabetes or blood sugar medications in the 3 months before screening, including GLP-1 receptor agonists, dual GIP/GLP-1 receptor agonists, sulfonylureas, meglitinides, thiazolidinediones, alpha-glucosidase inhibitors, linagliptin, saxagliptin, bile acid sequestrants, dopamine-2 agonists, amylin, or insulin (confirm with trial site if unsure which category a current medication falls into)
  • People whose fasting blood sugar level is 240 mg/dL or above
  • People whose fasting triglyceride level (a type of fat in the blood) is 500 mg/dL or above
  • People whose kidneys are not functioning well enough, based on a specific blood test measuring kidney filtration rate (eGFR below 75 mL/min/1.73 m²)
  • People with reduced liver function, based on blood test results showing elevated liver enzymes (AST or ALT) or raised bilirubin levels above certain thresholds

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 1-844-245-0490

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Biomea Fusion Inc.
Registry
ClinicalTrials.gov
Start date
27 March 2026
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov