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

NCT05731544 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: COVALENT-111
• Study Type: interventional
• Target: 443
• Locations: 2 countries
• Sites: 39

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; Type 2 Diabetes Mellitus; Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Safety Assessments

  Assessed by treatment emergent adverse events. (TEAEs), drug discontinuation due to TEAEs, serious adverse events, clinically significant laboratory, vital, and ECG evaluations.

  52 weeks

• Pharmacokinetics Assessments

  Assessed by effect of fed conditions on serial and sparse pharmacokinetic data.

  12 weeks

• Change in HbA1c

  Assess the change in HbA1c from baseline to week 26.

  26 weeks

Secondary Outcomes (1)

• To assess the effect on HbA1c

  26 Weeks

Other Outcomes (2)

• Exploratory: To determine the effects of BMF-219 on glycemic parameters in subjects with T2D.

  Week 26

• Exploratory: To determine the impact of multiple ascending doses of BMF-219 on beta-cell function in subjects with T2D.

  Week 26

Study Arms (5)

Phase 1 SAD Cohorts

EXPERIMENTAL

Phase 1 SAD Cohorts with healthy adults randomized 3:1 receiving BMF-219 or placebo. A pair of sentinel subjects (randomly assigned 1 active drug and 1 placebo) will be dosed 48 hours prior to dosing of the remainder of subjects in each cohort.

Drug: BMF-219

Phase 1 single dose food effect sub-study

EXPERIMENTAL

Phase 1 single dose food effect sub-study with healthy adults randomized 1:1:1:1:1:1 receiving BMF-219 or placebo fasted, with a low-fat meal, and with a high fat meal.

Drug: BMF-219

Phase 1 single dose tablet PK sub-study

EXPERIMENTAL

Phase 1 single dose x3 PK tablet open-label sub-study with healthy adults randomized 1:1 receiving BMF-219 or placebo fasted, with a low-fat meal, and with a high-fat meal).

Drug: BMF-219

Phase 2 MAD Cohorts

EXPERIMENTAL

Phase 2 MAD Cohorts with healthy adults (MAD 1, randomized 3:1) or adults with T2D (MAD 2-4 \& 6-8, randomized 5:1) receiving BMF-219 or placebo. MAD 5 is BMF-219 only.

Drug: BMF-219

Phase 2 Expansion Cohort

EXPERIMENTAL

Phase 2 Expansion Cohort adults with T2D randomized 3:1 ratio receiving BMF-219 or placebo.

Drug: BMF-219

Interventions

BMF-219 DRUG

Investigational Product

Phase 1 SAD Cohorts; Phase 1 single dose food effect sub-study; Phase 1 single dose tablet PK sub-study; Phase 2 Expansion Cohort; Phase 2 MAD Cohorts

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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%.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Biomea Fusion Inc.: lead

Study Sites (39)

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

Ark Clinical Research, LLC

Fountain Valley, California, 92708, United States

Location

Velocity Clinical Research

La Mesa, California, 91942, United States

Location

Ark Clinical Research

Long Beach, California, 90815, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Metro Clinical Trials

San Bernardino, California, 92404, United States

Location

Southwest General Healthcare Center

Fort Myers, Florida, 33907, United States

Location

G+C Research Group

Hialeah, Florida, 33010, United States

Location

Sunbright Health Research Centers

Homestead, Florida, 33032, United States

Location

Avantis Clinical Research

Miami, Florida, 33155, United States

Location

Century Research LLC

Miami, Florida, 33173, United States

Location

Entrust Clinical Research

Miami, Florida, 33176, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

David Kavtaradze MD, Inc

Cordele, Georgia, 31015, United States

Location

Privia Medical Group

Savannah, Georgia, 31406, United States

Location

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

Location

IMA Clinical Research St. Louis

St Louis, Missouri, 63117, United States

Location

Santa Rosa Medical Centers of Nevada

Las Vegas, Nevada, 89119, United States

Location

Omera Health

Brooklyn, New York, 11220, United States

Location

IMA Clinical Research Manhattan

New York, New York, 10036, United States

Location

Carolina Research Center

Shelby, North Carolina, 28150, United States

Location

Wake Forest Health Network, LLC, Medical Plaza

Winston-Salem, North Carolina, 27104, United States

Location

Diabetes and Endocrinology Associates of Stark County

Canton, Ohio, 44718, United States

Location

Medical Care, LLC

Elizabethton, Tennessee, 37643, United States

Location

IMA Clinical Research

Austin, Texas, 78745, United States

Location

Velocity Clinical Research

Dallas, Texas, 75230, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

Synergy Groups Medical LLC

Houston, Texas, 77036, United States

Location

Synergy Group Medical

Houston, Texas, 77061, United States

Location

Synergy Group Medical

Missouri City, Texas, 77459, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, 78229, United States

Location

Simcare Medical Research

Sugar Land, Texas, 77478, United States

Location

Velocity Clinical Research

Waco, Texas, 76710, United States

Location

Velocity Clinical Research

Jordan, Utah, 84088, United States

Location

Manassas Clinical Research

Manassas, Virginia, 20110, United States

Location

BC Diabetes

Vancouver, British Columbia, V5Y 3W2, Canada

Location

Centricity Research LMC

Toronto, Ontario, M4G 3E8, Canada

Location

BioPharma Services Inc.

Toronto, M9L 3A2, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Biomea Fusion Inc.

  Biomea Fusion Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The subject and the investigator involved in the treatment or clinical evaluation of the subjects will be unaware of the group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: February 16, 2023
• Study Start: August 17, 2022
• Primary Completion: November 18, 2024
• Study Completion: July 8, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (36)