Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus
Purpose
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.
Conditions
- Type 2 Diabetes Mellitus
- T2DM
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental HM15275 |
Participants will receive HM15275 via subcutaneous (SC) injection. |
|
|
Placebo Comparator Placebo of HM15275 |
Participants will receive placebo of HM15275 via subcutaneous (SC) injection. |
|
Recruiting Locations
Glendale, Arizona 85308
Mesa, Arizona 85123
South Bend, Indiana 46617
Jefferson City, Missouri 65109
Kansas City, Missouri 64151
Las Vegas, Nevada 89119
Salt Lake City, Utah 84117
More Details
- Status
- Recruiting
- Sponsor
- Hanmi Pharmaceutical Company Limited
Detailed Description
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.