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
Age:
18 – 65 years
18 – 65 years
Sex:
Female & Male
Female & Male
Conditions:
Type 2 Diabetes
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.
Trial locations
Contact us
Phone:
1 (844) 245-0490
1 (844) 245-0490
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.