Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (T2D)

Completed · Phase 1/Phase 2

Conditions studied: Type 2 Diabetes Mellitus

In brief

A Phase 1/ 2 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMF-219, an Oral Covalent Menin Inhibitor, in Healthy Adult Subjects and in Adult Subjects with Type 2 Diabetes Mellitus.

Key facts

Study ID

NCT05731544

Run by

Biomea Fusion Inc.

People needed

443

Starts

2022-08-17

Expected to finish

2025-07-08

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy Subject Inclusion Criteria:
• Males or females, age ≥18 and ≤65 years.
• BMI ≥18 and ≤35 kg/m2.
• Subjects are healthy on the basis of their medical history, physical examination, ECG, and routine laboratory data.
• 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:
• Males or females, age ≥18 and ≤65 years.
• Diagnosed with T2D within the last 15 years.
• 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.
• HbA1c ≥7.0% and ≤10.5%.
• BMI ≥25 and ≤40 kg/m2.
• Females are to be not pregnant, non-lactating.
• 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:
• Males or females, age ≥18 and ≤65 years.
• Diagnosed with T2D within the last 7 years.
• 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.
• HbA1c ≥7.0% and ≤10.5%.
• BMI ≥25 and ≤40 kg/m2.
• Females are to be not pregnant, non-lactating.
• 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.

You may not qualify if…

• Healthy Subject Exclusion Criteria:
• Evidence or history of any clinically significant disease or malignancy.
• Mean QTcF ≥ 440 msec on triplicate ECGs. Use of medications known to significantly prolong the QT or QTcF interval.
• History of hypertension or untreated hypertension (sitting systolic blood pressure (BP) ≥140 and diastolic BP ≥90 mm Hg).
• Known self or family history (first-degree relative) of multiple endocrine neoplasia Type 1.
• History of stomach or intestinal surgery or resection (except appendectomy, hernia repair, and/or cholecystectomy).
• A history or evidence of HIV, HCV, or HBV infection at screening or active COVID-19 infection on screening.
• Receiving an investigational intervention or having participated in another clinical trial within 30 days.
• Currently dieting (formal weight loss program) and/or are currently using or have used within 2 months of screening any drugs for weight management.
• Received prior menin inhibitor treatment.
• Subjects with T2D (MAD Cohorts) Exclusion Criteria:
• Type 1 Diabetes Mellitus or a secondary form of diabetes or any prior history of diabetic ketoacidosis.
• 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.
• Known self or family history (first-degree relative) of multiple endocrine neoplasia Type 1.
• 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.
• Fasting plasma glucose ≥255 mg/dL, fasting C-peptide <0.8 ng/mL, fasting insulin >55 μIU/mL.
• Mean QTcF ≥450 ms. Use of medications known to significantly prolong the QT or QTc interval.
• Fasting triglyceride ≥500 mg/dL.
• Have an eGFR <60 mL/min/1.73 Equation at screening.
• 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.
• History of acute or chronic pancreatitis and serum lipase and/or amylase above 1.5 x ULN.
• 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.
• TSH >6 mIU/L or <0.4 mIU/L (on stable thyroid replacement dose for 3 months prior to screening).
• Severe uncontrolled treated or untreated hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg).
• History of stomach or intestinal surgery or resection and/or gastroparesis (except that appendectomy, hernia repair, and/or cholecystectomy will be allowed).

Where it is running

• Hope Clinical Research — Canoga Park, California, United States
• Ark Clinical Research, LLC — Fountain Valley, California, United States
• Velocity Clinical Research — La Mesa, California, United States
• Ark Clinical Research — Long Beach, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Metro Clinical Trials — San Bernardino, California, United States
• Southwest General Healthcare Center — Fort Myers, Florida, United States
• G+C Research Group — Hialeah, Florida, United States
• Sunbright Health Research Centers — Homestead, Florida, United States
• Avantis Clinical Research — Miami, Florida, United States
• Century Research LLC — Miami, Florida, United States
• Entrust Clinical Research — Miami, Florida, United States
• Panax Clinical Research — Miami Lakes, Florida, United States
• David Kavtaradze MD, Inc — Cordele, Georgia, United States
• Privia Medical Group — Savannah, Georgia, United States
• Cedar Crosse Research Center — Chicago, Illinois, United States
• IMA Clinical Research St. Louis — St Louis, Missouri, United States
• Santa Rosa Medical Centers of Nevada — Las Vegas, Nevada, United States
• Omera Health — Brooklyn, New York, United States
• IMA Clinical Research Manhattan — New York, New York, United States
• Carolina Research Center — Shelby, North Carolina, United States
• Wake Forest Health Network, LLC, Medical Plaza — Winston-Salem, North Carolina, United States
• Diabetes and Endocrinology Associates of Stark County — Canton, Ohio, United States
• Medical Care, LLC — Elizabethton, Tennessee, United States
• IMA Clinical Research — Austin, Texas, United States

Full record on ClinicalTrials.gov

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