Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Subjects With Type 2 Diabetes Mellitus

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.

Key Inclusion Criteria

1. Participant's age at the time of signing the informed consent:

   • United States: 18 to 75 years (inclusive)

2. Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening

3. Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for at least 3 months prior to screening

4. BMI ≥25 kg/m² and ≤50 kg/m²

5. Body weight change <5% over the past 3 months prior to screening

6. Capable of giving signed informed consent and willing to comply with all protocol procedures

Key Exclusion Criteria

1. Type 1 diabetes mellitus or use of glucose-lowering medications other than metformin within 3 months prior to screening
2. Poor glycemic control (fasting plasma glucose >270 mg/dL)
3. History of diabetic ketoacidosis or severe hypoglycemia within 6 months
4. Clinically significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction, stroke, or revascularization within 3 months)
5. History of pancreatitis or factors increasing the risk of pancreatitis
6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2
7. Clinically significant liver disease, renal impairment (eGFR <60 mL/min/1.73 m²), or abnormal laboratory findings at screening
8. 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