Overview
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.
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.
Eligibility
Key Inclusion Criteria
- Participant's age at the time of signing the informed consent:
- United States: 18 to 75 years (inclusive)
- 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
- Type 1 diabetes mellitus or use of glucose-lowering medications other than metformin within 3 months prior to screening
- Poor glycemic control (fasting plasma glucose \>270 mg/dL)
- History of diabetic ketoacidosis or severe hypoglycemia within 6 months
- Clinically significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction, stroke, or revascularization within 3 months)
- History of pancreatitis or factors increasing the risk of pancreatitis
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2
- Clinically significant liver disease, renal impairment (eGFR \<60 mL/min/1.73 m²), or abnormal laboratory findings at screening
- Participation in another investigational study within 30 days or within 5 half-lives of the investigational product, whichever is longer; for GLP-1 receptor agonist-related or weight loss studies, participation within 3 months prior to screening
