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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.
A sterile, matching solution supplied in pre-filled syringes.
Desert Clinical Research
Mesa, Arizona, United States
RECRUITINGAccel Research Sites - DeLand
DeLand, Florida, United States
Change in Glycated Hemoglobin (HbA1c)
Change in HbA1c (%) from randomization to Week 37.
Time frame: Up to 41 weeks
Percentage of participants reaching specified HbA1c (%)
Percentage of participants reaching specified high, medium, and low HbA1c (%) after multiple subcutaneous (SC) doses.
Time frame: Up to 41 weeks
Number of participants with adverse events (AEs)
Number of participants with adverse events (AEs) after multiple subcutaneous (SC) doses.
Time frame: Up to 41 weeks
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Charter Research
Orlando, Florida, United States
RECRUITINGAdventHealth Translational Research Institute
Orlando, Florida, United States
NOT_YET_RECRUITINGK2 Medical Research The Villages LLC
The Villages, Florida, United States
RECRUITINGCentricity Research IRT - DBA IACT Health Columbus Piedmont
Columbus, Georgia, United States
RECRUITINGThe South Bend Clinic
South Bend, Indiana, United States
RECRUITINGJefferson City Medical Center
Jefferson City, Missouri, United States
RECRUITINGClay Platte Family Medicine
Kansas City, Missouri, United States
RECRUITINGMethodist Physicians Clinic
Fremont, Nebraska, United States
RECRUITING...and 5 more locations