Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (T2D)
NCT ID: NCT05731544
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
443 participants
INTERVENTIONAL
2022-08-17
2025-07-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Phase 1 SAD Cohorts
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.
BMF-219
Investigational Product
Phase 1 single dose food effect sub-study
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.
BMF-219
Investigational Product
Phase 1 single dose tablet PK sub-study
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).
BMF-219
Investigational Product
Phase 2 MAD Cohorts
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.
BMF-219
Investigational Product
Phase 2 Expansion Cohort
Phase 2 Expansion Cohort adults with T2D randomized 3:1 ratio receiving BMF-219 or placebo.
BMF-219
Investigational Product
Interventions
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BMF-219
Investigational Product
Eligibility Criteria
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Inclusion Criteria
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.
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.
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
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.
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.
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.
18 Years
65 Years
ALL
Yes
Sponsors
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Biomea Fusion Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Biomea Fusion Inc.
Role: STUDY_DIRECTOR
Biomea Fusion Inc.
Locations
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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
Velocity Clinical Research
Dallas, Texas, United States
Zenos Clinical Research
Dallas, Texas, United States
Synergy Groups Medical LLC
Houston, Texas, United States
Synergy Group Medical
Houston, Texas, United States
Synergy Group Medical
Missouri City, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, United States
Simcare Medical Research
Sugar Land, Texas, United States
Velocity Clinical Research
Waco, Texas, United States
Velocity Clinical Research
Jordan, Utah, United States
Manassas Clinical Research
Manassas, Virginia, United States
BC Diabetes
Vancouver, British Columbia, Canada
Centricity Research LMC
Toronto, Ontario, Canada
BioPharma Services Inc.
Toronto, , Canada
Countries
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Other Identifiers
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COVALENT-111
Identifier Type: -
Identifier Source: org_study_id