Status and phase
Conditions
Treatments
About
This study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes mellitus over 36 weeks.
Full description
HM-OBCT-202 is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, parallel-group study designed to evaluate the efficacy, safety, and tolerability of HM15275 treatment over 36 weeks in adults with type 2 diabetes mellitus (T2DM).
The study will enroll adult participants with T2DM (aged 18 to 75 years) who have inadequate glycemic control. Eligible participants must have a body mass index (BMI) ≥25 kg/m² and ≤50 kg/m² and HbA1c between 7.0% and 10.0% at screening.
Participants in this study will be randomly assigned in a 1:1:1:1 ratio to 1 of the 4 treatment arms. Randomization will be stratified by screening HbA1c (≤8.0% versus >8.0%) and use of metformin (yes versus no).
All participants will undergo a 4-week screening period, a 36-week treatment period (including weekly subcutaneous [SC] injection of study drug), and a 4-week safety follow-up period.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria
Participant's age at the time of signing the informed consent:
Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening
Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for at least 3 months prior to screening
BMI ≥25 kg/m² and ≤50 kg/m²
Body weight change <5% over the past 3 months prior to screening
Capable of giving signed informed consent and willing to comply with all protocol procedures
Key Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
180 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
Hyeonho Choi; Pureun Nam
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal