Type 2 Diabetes MellitusPhase 1/2NCT05731544
Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (T2D)
A Phase 1/2 study testing BMF-219 in people with Type 2 Diabetes Mellitus, run by Biomea Fusion Inc. at 39 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- BMF-219
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 443 participants
- Where
- 39 sitesin 2 countries
- Study dates
- 17 Aug 2022to 8 Jul 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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).
Show all 45Show fewer
- 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).
- History of cirrhosis.
- 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:
- Type 1 Diabetes Mellitus or a secondary form of diabetes.
- Prior history of diabetic ketoacidosis or hyperosmolar coma.
- 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.
- Known self or family history (first-degree relative) of multiple endocrine neoplasia Type 1 (MEN1).
- 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.
- Fasting plasma glucose ≥255 mg/dL, fasting C-peptide <0.8 ng/mL, fasting insulin >55 μIU/mL.
- 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.
- Fasting triglyceride ≥500 mg/dL.
- eGFR<60 mL/min/1.73.
- AST or ALT >1.5 × ULN, Total bilirubin >1.5 × ULN at screening.
- 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 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.
- History of cirrhosis.
- Currently dieting (formal weight loss program) and/or are currently using or have used within 2 months of screening any drugs for weight management.
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
United States36 sites
IMA Clinical Research
Austin, Texas, 78745
Omera Health
Brooklyn, New York, 11220
Hope Clinical Research
Canoga Park, California, 91303
Diabetes and Endocrinology Associates of Stark County
Canton, Ohio, 44718
Cedar Crosse Research Center
Chicago, Illinois, 60607
David Kavtaradze MD, Inc
Cordele, Georgia, 31015
Velocity Clinical Research
Dallas, Texas, 75230
Zenos Clinical Research
Dallas, Texas, 75230
Medical Care, LLC
Elizabethton, Tennessee, 37643
Southwest General Healthcare Center
Fort Myers, Florida, 33907
Ark Clinical Research, LLC
Fountain Valley, California, 92708
G+C Research Group
Hialeah, Florida, 33010
Sunbright Health Research Centers
Homestead, Florida, 33032
Synergy Groups Medical LLC
Houston, Texas, 77036
Synergy Group Medical
Houston, Texas, 77061
Velocity Clinical Research
Jordan, Utah, 84088
Velocity Clinical Research
La Mesa, California, 91942
Santa Rosa Medical Centers of Nevada
Las Vegas, Nevada, 89119
Ark Clinical Research
Long Beach, California, 90815
Manassas Clinical Research
Manassas, Virginia, 20110
Avantis Clinical Research
Miami, Florida, 33155
Century Research LLC
Miami, Florida, 33173
Entrust Clinical Research
Miami, Florida, 33176
Panax Clinical Research
Miami Lakes, Florida, 33014
Synergy Group Medical
Missouri City, Texas, 77459
Catalina Research Institute, LLC
Montclair, California, 91763
IMA Clinical Research Manhattan
New York, New York, 10036
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
Metro Clinical Trials
San Bernardino, California, 92404
Privia Medical Group
Savannah, Georgia, 31406
Carolina Research Center
Shelby, North Carolina, 28150
IMA Clinical Research St. Louis
St Louis, Missouri, 63117
Simcare Medical Research
Sugar Land, Texas, 77478
Velocity Clinical Research
Waco, Texas, 76710
Wake Forest Health Network, LLC, Medical Plaza
Winston-Salem, North Carolina, 27104
Canada3 sites
Centricity Research LMC
Toronto, Ontario, M4G 3E8
BioPharma Services Inc.
Toronto, M9L 3A2
BC Diabetes
Vancouver, British Columbia, V5Y 3W2
About this study
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
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.
Read the detailed description
This is a Phase 1/ 2 study that will examine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple dose levels of BMF-219, an orally bioavailable selective covalent inhibitor of menin, in healthy subjects and in subjects with T2D. This study will assess the effect of BMF-219 as single ascending dose (SAD) and multiple ascending dose (MAD), Expansion Cohort will explore 100mg and 200mg dose levels.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- BMF-219, Placebo
- Keywords
- Diabetes, Type 2 Diabetes Mellitus, Healthy Volunteers
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMF-219Drug
Investigational Product
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BMF-219; Drug: Placebo |
| 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 fasted, with a low-fat meal, and with a high fat meal. Receives: 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 fasted, with a low-fat meal, and with a high-fat meal). Receives: 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. Receives: Drug: BMF-219; Drug: Placebo |
| Phase 2 Expansion Cohort | Experimental | Phase 2 Expansion Cohort adults with T2D randomized 3:1 ratio receiving BMF-219 or placebo. Receives: Drug: BMF-219; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessments
Assessed by treatment emergent adverse events. (TEAEs), drug discontinuation due to TEAEs, serious adverse events, clinically significant laboratory, vital, and ECG evaluations.
Measured: 52 weeks
Pharmacokinetics Assessments
Assessed by effect of fed conditions on serial and sparse pharmacokinetic data.
Measured: 12 weeks
Change in HbA1c
Assess the change in HbA1c from baseline to week 26.
Measured: 26 weeks
Secondary outcomes (1)
To assess the effect on HbA1c
Proportion of subjects achieving an HbA1c < 7% at Week 26.
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start17 Aug 2022
- Primary completion18 Nov 2024
- Study completion8 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomea Fusion Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biomea Fusion Inc., Study director, Biomea Fusion Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731544
- Sponsor's protocol ID
- COVALENT-111
- Status last verified
- Oct 2026
- First submitted
- 26 Dec 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05731544
- Acronym / sponsor ID
- COVALENT-111
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes, Type 2 Diabetes Mellitus, Healthy Volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Biomea Fusion Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1/ 2 study that will examine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple dose levels of BMF-219, an orally bioavailable selective covalent inhibitor of menin, in healthy subjects and in subjects with T2D. This study will assess the effect of BMF-219 as single ascending dose (SAD) and multiple ascending dose (MAD), Expansion Cohort will explore 100mg and 200mg dose levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1 SAD Cohorts | Experimental | Drug: BMF-219, Drug: PlaceboPhase 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. |
| Phase 1 single dose food effect sub-study | Experimental | Drug: BMF-219Phase 1 single dose food effect sub-study with healthy adults randomized 1:1:1:1:1:1 receiving BMF-219 fasted, with a low-fat meal, and with a high fat meal. |
| Phase 1 single dose tablet PK sub-study | Experimental | Drug: BMF-219Phase 1 single dose x3 PK tablet open-label sub-study with healthy adults randomized 1:1 receiving BMF-219 fasted, with a low-fat meal, and with a high-fat meal). |
| Phase 2 MAD Cohorts | Experimental | Drug: BMF-219, Drug: PlaceboPhase 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. |
| Phase 2 Expansion Cohort | Experimental | Drug: BMF-219, Drug: PlaceboPhase 2 Expansion Cohort adults with T2D randomized 3:1 ratio receiving BMF-219 or placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (45 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMF-219Investigational Product | Drug | 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 |
| PlaceboPlacebo | Drug | Phase 1 SAD Cohorts, Phase 2 Expansion Cohort, Phase 2 MAD Cohorts |
Primary outcome
Safety Assessments
Time frame: 52 weeks
Assessed by treatment emergent adverse events. (TEAEs), drug discontinuation due to TEAEs, serious adverse events, clinically significant laboratory, vital, and ECG evaluations.
Pharmacokinetics Assessments
Time frame: 12 weeks
Assessed by effect of fed conditions on serial and sparse pharmacokinetic data.
Change in HbA1c
Time frame: 26 weeks
Assess the change in HbA1c from baseline to week 26.
1 secondary outcome
To assess the effect on HbA1c
Time frame: 26 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biomea Fusion Inc. study director
Biomea Fusion Inc.
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMF-219 in people with Type 2 Diabetes Mellitus, run by Biomea Fusion Inc. at 39 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessments (time frame: 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.