Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus
About this study
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.
- Condition
- Type 2 Diabetes Mellitus, T2DM
- Tested
- HM15275, Placebo of HM15275
- Sponsor
- Hanmi Pharmaceutical Company Limited
Who can join
- Age
- 18 to 75 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 10
- Minimum age: 18 years
- Maximum age: 75 years
- Study condition: Type 2 Diabetes Mellitus, T2DM
- 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 8
- 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
Where
15 sites, 15 recruiting
Centricity Research IRT - DBA IACT Health Columbus Piedmont
Columbus, Georgia, United States
Centricity Research Columbus
Columbus, Ohio, United States
Accel Research Sites - DeLand
DeLand, Florida, United States
Methodist Physicians Clinic
Fremont, Nebraska, United States
Jefferson City Medical Center
Jefferson City, Missouri, United States
Clay Platte Family Medicine
Kansas City, Missouri, United States
and 9 more sites on ClinicalTrials.gov
Contact
-
Pureun Nam
+82-2-410-9147 pureun.nam@hanmi.co.kr
-
Hyeonho Choi
+82-2-410-9834 hyeonho.choi@hanmi.co.kr
Potential match only. Final eligibility is determined by the study team.