← Back to all trials
Recruiting
NCT07527650
Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus
Conditions: Type 2 Diabetes Mellitus, T2DM
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 180
Sponsor: Hanmi Pharmaceutical Company Limited
Location: Desert Clinical Research Mesa Arizona
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 Criteria
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 \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 \
Source: ClinicalTrials.gov (NCT07527650). StuddyBuddy aggregates publicly available trial information.