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New pill shows promise in controlling blood sugar for type 2 diabetes

NCT ID NCT05731544

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new daily pill, BMF-219, in healthy adults and people with type 2 diabetes. The goal was to see if it is safe and helps lower blood sugar levels over 26 weeks. About 443 participants took either the drug or a placebo to compare results.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

443 people

The number who actually took part.

Started

Aug 2022

Finished

Jul 2025

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 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Inclusion Criteria: Healthy Subject Inclusion Criteria: 1. Males or females, age ≥18 and ≤65 years. 2. BMI ≥18 and ≤35 kg/m2. 3. Subjects are healthy on the basis of their medical history, physical examination, ECG, and routine laboratory data. 4. All subjects must be willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests. Subjects with T2D: (MAD Cohorts) Inclusion Criteria: 1. Males or females, age ≥18 and ≤65 years. 2. Diagnosed with T2D within the last 15 years. 3. Treated with lifestyle management with or without at the most 3 anti-diabetic medications with a stable dose for at least 2 months prior to screening. If on metformin, the stable dose should be at least 500mg/day. 4. HbA1c ≥7.0% and ≤10.5%. 5. BMI ≥25 and ≤40 kg/m2. 6. Females are to be not pregnant, non-lactating. 7. All Subjects must be willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests. Subjects with T2D: (Expansion Cohort) Inclusion Criteria: 1. Males or females, age ≥18 and ≤65 years. 2. Diagnosed with T2D within the last 7 years. 3. Treated with lifestyle management with or without at the most 3 anti-diabetic medications with a stable dose for at least 2 months prior to screening. If on metformin, the stable dose should be at least 500mg/day. 4. HbA1c ≥7.0% and ≤10.5%. 5. BMI ≥25 and ≤40 kg/m2. 6. Females are to be not pregnant, non-lactating. 7. All Subjects must be willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests. Exclusion Criteria: Healthy Subject Exclusion Criteria: 1. Evidence or history of any clinically significant disease or malignancy. 2. Mean QTcF ≥ 440 msec on triplicate ECGs. Use of medications known to significantly prolong the QT or QTcF interval. 3. History of hypertension or untreated hypertension (sitting systolic blood pressure (BP) ≥140 and diastolic BP ≥90 mm Hg). 4. Known self or family history (first-degree relative) of multiple endocrine neoplasia Type 1. 5. History of stomach or intestinal surgery or resection (except appendectomy, hernia repair, and/or cholecystectomy). 6. A history or evidence of HIV, HCV, or HBV infection at screening or active COVID-19 infection on screening. 7. Receiving an investigational intervention or having participated in another clinical trial within 30 days. 8. Currently dieting (formal weight loss program) and/or are currently using or have used within 2 months of screening any drugs for weight management. 9. Received prior menin inhibitor treatment. Subjects with T2D (MAD Cohorts) Exclusion Criteria: 1. Type 1 Diabetes Mellitus or a secondary form of diabetes or any prior history of diabetic ketoacidosis. 2. Have had recurrence (≥2 episodes) of severe hypoglycemia (defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery) within the last 6 months prior to screening or, has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms as judged by the Investigator. 3. Known self or family history (first-degree relative) of multiple endocrine neoplasia Type 1. 4. Use of anti-diabetes medications (sulfonylureas, insulin, dipeptidyl peptidase-IV inhibitor \[DPP-4I\] \[linagliptin and saxagliptin only\] thiazolidinediones) within last 2 months prior to screening. 5. Fasting plasma glucose ≥255 mg/dL, fasting C-peptide \<0.8 ng/mL, fasting insulin \>55 μIU/mL. 6. Mean QTcF ≥450 ms. Use of medications known to significantly prolong the QT or QTc interval. 7. Fasting triglyceride ≥500 mg/dL. 8. Have an eGFR \<60 mL/min/1.73 Equation at screening. 9. AST or ALT \> 1.5 × ULN, bilirubin \> 1.5 × ULN. Isolated GGT elevation \>2.5 ULN without \> 1.5 x ULN AST, ALT and/or total bilirubin but with a history of abnormal LFTs in the last 6 months or a medical history of a liver disorder should be excluded. 10. History of acute or chronic pancreatitis and serum lipase and/or amylase above 1.5 x ULN. 11. Active HBV or active HCV at screening. Known positive test, if any, prior to screening or history of HIV. An active COVID-19 infection at screening. 12. TSH \>6 mIU/L or \<0.4 mIU/L (on stable thyroid replacement dose for 3 months prior to screening). 13. Severe uncontrolled treated or untreated hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg). 14. History of stomach or intestinal surgery or resection and/or gastroparesis (except that appendectomy, hernia repair, and/or cholecystectomy will be allowed). 15. History of cirrhosis. 16. Currently dieting (formal weight loss program) and/or are currently using or have used within 2 months of screening any drugs for weight management. Subjects with T2D (Expansion Cohort) Exclusion Criteria: 1. Type 1 Diabetes Mellitus or a secondary form of diabetes. 2. Prior history of diabetic ketoacidosis or hyperosmolar coma. 3. History of severe hypoglycemia (defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery) within the last 6 months prior to screening or, has a history of hypoglycemia unawareness. 4. Known self or family history (first-degree relative) of multiple endocrine neoplasia Type 1 (MEN1). 5. Use of any of the following anti-diabetes medications within 2 months prior to screening: sulfonylureas, insulin, and the dipeptidyl peptidase-4 inhibitors (DPP4i) linagliptin and saxagliptin (sitagliptin and other DPP4i allowed) thiazolidinones \[TZD\]) within last 2 months prior to screening. 6. Fasting plasma glucose ≥255 mg/dL, fasting C-peptide \<0.8 ng/mL, fasting insulin \>55 μIU/mL. 7. Mean QTcF interval \>450 ms on triplicate ECGs. Use of prescription or over-the-counter medications known to significantly prolong the QT or QTc interval is excluded. 8. Fasting triglyceride ≥500 mg/dL. 9. eGFR\<60 mL/min/1.73. 10. AST or ALT \>1.5 × ULN, Total bilirubin \>1.5 × ULN at screening. 11. History of acute or chronic pancreatitis and serum lipase and/or amylase above 1.5 x ULN. 12. Active HBV or active HCV at screening. Known positive test or history of HIV. An active COVID-19 infection at screening. 13. TSH \>6 mIU/L or \<0.4 mIU/L (on stable thyroid replacement dose for 3 months prior to screening). 14. Severe uncontrolled treated or untreated hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg). 15. History of stomach or intestinal surgery or resection and/or gastroparesis. 16. History of cirrhosis. 17. Currently dieting (formal weight loss program) and/or are currently using or have used within 2 months of screening any drugs for weight management.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

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

Type 2 diabetes mellitus

Contacts and locations

Locations

  • Ark Clinical Research

    Long Beach, California, 90815, United States

  • Ark Clinical Research, LLC

    Fountain Valley, California, 92708, United States

  • Avantis Clinical Research

    Miami, Florida, 33155, United States

  • BC Diabetes

    Vancouver, British Columbia, V5Y 3W2, Canada

  • BioPharma Services Inc.

    Toronto, M9L 3A2, Canada

  • Carolina Research Center

    Shelby, North Carolina, 28150, United States

  • Catalina Research Institute, LLC

    Montclair, California, 91763, United States

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607, United States

  • Centricity Research LMC

    Toronto, Ontario, M4G 3E8, Canada

  • Century Research LLC

    Miami, Florida, 33173, United States

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229, United States

  • David Kavtaradze MD, Inc

    Cordele, Georgia, 31015, United States

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas, 78229, United States

  • Diabetes and Endocrinology Associates of Stark County

    Canton, Ohio, 44718, United States

  • Entrust Clinical Research

    Miami, Florida, 33176, United States

  • G+C Research Group

    Hialeah, Florida, 33010, United States

  • Hope Clinical Research

    Canoga Park, California, 91303, United States

  • IMA Clinical Research

    Austin, Texas, 78745, United States

  • IMA Clinical Research Manhattan

    New York, New York, 10036, United States

  • IMA Clinical Research St. Louis

    St Louis, Missouri, 63117, United States

  • Manassas Clinical Research

    Manassas, Virginia, 20110, United States

  • Medical Care, LLC

    Elizabethton, Tennessee, 37643, United States

  • Metro Clinical Trials

    San Bernardino, California, 92404, United States

  • Omera Health

    Brooklyn, New York, 11220, United States

  • Panax Clinical Research

    Miami Lakes, Florida, 33014, United States

  • Privia Medical Group

    Savannah, Georgia, 31406, United States

  • Santa Rosa Medical Centers of Nevada

    Las Vegas, Nevada, 89119, United States

  • Simcare Medical Research

    Sugar Land, Texas, 77478, United States

  • Southwest General Healthcare Center

    Fort Myers, Florida, 33907, United States

  • Sunbright Health Research Centers

    Homestead, Florida, 33032, United States

  • Synergy Group Medical

    Houston, Texas, 77061, United States

  • Synergy Group Medical

    Missouri City, Texas, 77459, United States

  • Synergy Groups Medical LLC

    Houston, Texas, 77036, United States

  • Velocity Clinical Research

    La Mesa, California, 91942, United States

  • Velocity Clinical Research

    Dallas, Texas, 75230, United States

  • Velocity Clinical Research

    Waco, Texas, 76710, United States

  • Velocity Clinical Research

    Jordan, Utah, 84088, United States

  • Wake Forest Health Network, LLC, Medical Plaza

    Winston-Salem, North Carolina, 27104, United States

  • Zenos Clinical Research

    Dallas, Texas, 75230, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.