Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus
Recruiting · NCT07527650 · Interventional (participants receive a specific treatment) · Lead sponsor: Hanmi Pharmaceutical Company Limited
View the official record on ClinicalTrials.gov →Interventions studied
HM15275Placebo of HM15275
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
15 locations listed across 11 US states.
- Desert Clinical Research - Mesa, Arizona, United States
- Accel Research Sites - DeLand - DeLand, Florida, United States
- Charter Research - Orlando, Florida, United States
- AdventHealth Translational Research Institute - Orlando, Florida, United States
- K2 Medical Research The Villages LLC - The Villages, Florida, United States
- Centricity Research IRT - DBA IACT Health Columbus Piedmont - Columbus, Georgia, United States
- The South Bend Clinic - South Bend, Indiana, United States
- Jefferson City Medical Center - Jefferson City, Missouri, United States
- Clay Platte Family Medicine - Kansas City, Missouri, United States
- Methodist Physicians Clinic - Fremont, Nebraska, United States
- Santa Rosa Medical Centers of Nevada - Las Vegas, Nevada, United States
- Lucas Research, Inc. - Morehead City, North Carolina, United States
- Centricity Research Columbus - Columbus, Ohio, United States
- Olympus Family Medicine - Salt Lake City, Utah, United States
- Manassas Clinical Research Center - Manassas, Virginia, United States