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NCT05731544 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Biomea Fusion.

Completed
Registry status
Phase 1
Development phase
443
Enrollment target

NCT05731544: Completed Phase 1 study, sponsored by Biomea Fusion.

NCT05731544 is a Phase 1 study that has completed, run by Biomea Fusion. The registered enrollment target is 443 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (638% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05731544, a Phase 1 study, has completed, sponsored by Biomea Fusion.

COMPLETED
Registry status
Phase 1
Development phase
443 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • DRUG BMF-219

Trial Details

FieldValue
Enrollment Target 443 participants
Start Date 2022-08-17
Est. Completion 2025-07-08
Phase Phase 1
Biomea Fusion

9 total trials

What the finished NCT05731544 record still lists

NCT05731544 is an interventional study that assigns participants to a tested intervention. The registered 443 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (638% higher).

The record links to 0 conditions, and to 1 intervention - of which BMF-219 is the first listed.

NCT05731544 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05731544 about?

NCT05731544 is a clinical study titled "Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (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.

What is the current status of trial NCT05731544?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 443 participants. The study started on 2022-08-17. Estimated completion is 2025-07-08.

What interventions are being tested in trial NCT05731544?

The interventions under investigation include: BMF-219 (DRUG).

Who is sponsoring clinical trial NCT05731544?

This trial is sponsored by Biomea Fusion, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05731544's enrollment target sits among peer trials

443 59th of 2000 higher than 1,942 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05731544, the US trial registry maintained by the National Library of Medicine. NCT05731544 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.