> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-bmf-219-in-healthy-adult-subjects-and-in-adult-49a7005b-488c-471a-be4a-271d899a4d13 > Record changed: 2026-10-13 # Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (T2D) NCT05731544 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) Participants 443 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) Lead sponsor Biomea Fusion Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) Start date 2022-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) Number of sites 39 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Short title** Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (T2D) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Official title** A Phase 1/2 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, PK, and PD of BMF-219, an Oral Covalent Menin Inhibitor, in Healthy Adults and Adults With T2D Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) ## Dates **Completion date** 2025-07-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **First posted** 2023-02-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Registry last updated** 2025-11-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Primary completion date** 2024-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Start date** 2022-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) ## Size and sites **Actual participants** 443 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Participants** 443 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Number of sites** 39 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Lead sponsor** Biomea Fusion Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) ## Identifiers **Registry ID** NCT05731544 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **ClinicalTrials.gov ID** NCT05731544 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masking description** The subject and the investigator involved in the treatment or clinical evaluation of the subjects will be unaware of the group assignments. **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) ## Outcomes ### Primary outcomes 1. Safety Assessments Timeframe: 52 weeks Assessed by treatment emergent adverse events. (TEAEs), drug discontinuation due to TEAEs, serious adverse events, clinically significant laboratory, vital, and ECG evaluations. 2. Pharmacokinetics Assessments Timeframe: 12 weeks Assessed by effect of fed conditions on serial and sparse pharmacokinetic data. 3. Change in HbA1c Timeframe: 26 weeks Assess the change in HbA1c from baseline to week 26. ### Secondary outcomes 1. To assess the effect on HbA1c Timeframe: 26 Weeks Proportion of subjects achieving an HbA1c \\< 7% at Week 26. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) ## Sites - Hope Clinical ResearchCanoga Park, United States - Ark Clinical Research, LLCFountain Valley, United States - Velocity Clinical ResearchLa Mesa, United States - Ark Clinical ResearchLong Beach, United States - Catalina Research Institute, LLCMontclair, United States - Metro Clinical TrialsSan Bernardino, United States - Southwest General Healthcare CenterFort Myers, United States - G+C Research GroupHialeah, United States - Sunbright Health Research CentersHomestead, United States - Avantis Clinical ResearchMiami, United States - Century Research LLCMiami, United States - Entrust Clinical ResearchMiami, United States - Panax Clinical ResearchMiami Lakes, United States - David Kavtaradze MD, IncCordele, United States - Privia Medical GroupSavannah, United States - Cedar Crosse Research CenterChicago, United States - IMA Clinical Research St. LouisSt Louis, United States - Santa Rosa Medical Centers of NevadaLas Vegas, United States - Omera HealthBrooklyn, United States - IMA Clinical Research ManhattanNew York, United States - Carolina Research CenterShelby, United States - Wake Forest Health Network, LLC, Medical PlazaWinston-Salem, United States - Diabetes and Endocrinology Associates of Stark CountyCanton, United States - Medical Care, LLCElizabethton, United States - IMA Clinical ResearchAustin, United States And 14 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05731544) ## Related records ### Drugs (1) - [Icovamenib](https://trialight.com/data/asset/icovamenib-e775ec52-9b3d-4f8d-a0f2-7c632a43d1ef.md) ### Lead sponsors (1) - [Biomea Fusion Inc.](https://trialight.com/data/company/biomea-fusion-inc-10d0aa0c-0027-4b56-bd2b-2a8fc907f683.md) ### Conditions (2) - [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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