Recruiting
Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus
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.
ClinicalTrials.gov IDNCT07527650
PhasePHASE2
Enrollment180
SponsorHanmi Pharmaceutical Company Limited
Age18 Years
SexALL
Conditions studied
Type 2 Diabetes Mellitus, T2DM
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.
Interventions
- Drug: HM15275 — HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.
- Drug: Placebo of HM15275 — A sterile, matching solution supplied in pre-filled syringes.
Primary outcomes
- Change in Glycated Hemoglobin (HbA1c) (Up to 41 weeks)
Eligibility information
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 \<5% over the past 3 months prior to screening
6. Capable of giving signed informed consent and willing to comply with all protocol procedures
Key Exclusion Criteria
1. 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 locations
- Desert Clinical Research, Mesa, Arizona 85123 United States
- Accel Research Sites - DeLand, DeLand, Florida 32720 United States
- Charter Research, Orlando, Florida 32803 United States
- AdventHealth Translational Research Institute, Orlando, Florida 32804 United States
- K2 Medical Research The Villages LLC, The Villages, Florida 32159 United States
- Centricity Research IRT - DBA IACT Health Columbus Piedmont, Columbus, Georgia 31904 United States
- The South Bend Clinic, South Bend, Indiana 46617 United States
- Jefferson City Medical Center, Jefferson City, Missouri 65109 United States
- Clay Platte Family Medicine, Kansas City, Missouri 64151 United States
- Methodist Physicians Clinic, Fremont, Nebraska 68025 United States
Showing 10 of 15 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.