HM15275 in adults with type 2 diabetes who have not yet reached goal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, double-blind, placebo-controlled study, adults with type 2 diabetes and overweight/obesity will receive HM15275 or placebo for 36 weeks across multiple centers. Participants are stratified by baseline HbA1c and metformin use and receive weekly subcutaneous injections. The trial includes a 4-week screening period, a 36-week treatment period, and a 4-week safety follow-up. Eligibility requires HbA1c 7.0–10.0%, BMI 25–50 kg/m², and prior stable diabetes management. Key exclusion criteria include type 1 diabetes, recent major cardiovascular events, and uncontrolled hyperglycemia.

Why it matters

Who can join: the full rules

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

Where it's running

• Desert Clinical Research
  Mesa, Arizona, United States Recruiting
• Care Access Research - Santa Clarita
  Santa Clarita, California, United States Recruiting
• Accel Research Sites - DeLand
  DeLand, Florida, United States Recruiting
• Charter Research
  Orlando, Florida, United States Recruiting
• AdventHealth Translational Research Institute
  Orlando, Florida, United States Recruiting
• K2 Medical Research The Villages LLC
  The Villages, Florida, United States Recruiting

Study contacts

• Study coordinator: Pureun Nam
• Email: pureun.nam@hanmi.co.kr
• Phone: +82-2-410-9147

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.