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
Hanmi Pharmaceutical Company Limited
180 participants
Jun 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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
Exclusion Criteria8
- 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
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Interventions
HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.
A sterile, matching solution supplied in pre-filled syringes.
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07527650