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A phase 1/2 clinical trial in healthy adults and adults with Type 2 diabetes.

About COVALENT-111

This is a multicenter, randomized, double-blind, placebo-controlled trial seeking to determine the safety, tolerability, and efficacy of BMF-219 in Type 2 diabetes. 

What does it mean to be randomized, double-blind, placebo-controlled study?

It means that 5 out of 6 patients will receive the BMF-219, the study drug, and 1 out of 6 patients will receive placebo for each dose level. This allocation will be based on chance and neither the treating physician nor the patient will know their assignment during the treatment period.

Will it cost me anything?

Study medication and study-related care will be provided at no cost.

Phase II Patient eligibility 

18 – 65 years
Female & Male
Type 2 Diabetes

Patients would qualify for the trial if they meet the following criteria:

  • Be 18 to 60 years of age
  • All sexes included
  • Diagnosed with Type 2 diabetes within the last 15 years

And also:

  • HbA1c ≥ 7.0% and ≤ 10%
  • BMI ≥ 25 and ≤ 40 kg/m2

The science behind COVALENT-111

Beta cells in the pancreas are responsible for producing, storing, and releasing insulin. The protein menin is a key regulator controlling beta cell growth, preventing excessive proliferation in healthy individuals. Loss of functional beta cell mass is a root cause of diabetes; without enough healthy, functional beta cells, people with type 2 diabetes are unable to produce sufficient amounts of insulin.

BMF-219 was specifically designed to inhibit menin and has shown the potential to restore functional beta cell mass in preclinical studies.

What is BMF-219?

BMF-219 is an investigational, orally bioavailable small molecule, which covalently binds to the scaffold protein menin, an important transcriptional regulator known to play a direct role in regulating beta cell growth.

Contact us

If you think this clinical trial might be a good fit and you’re interested in taking part, fill out the form below or call our hotline to contact our clinical trials team.

Our clinical trials team will contact you shortly after your form submission.