Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
180 (estimated)
Sponsor
Hanmi Pharmaceutical Company Limited · Industry
Who this trial is looking for
This trial is looking for adults with type 2 diabetes to test a new treatment called HM15275. Participants will be monitored for 36 weeks to see how well the treatment works and if it is safe.
I have been on a stable dose of metformin or only diet and exercise for at least 3 months.
I have a BMI of 25 to 50.
My body weight has not changed more than 5% in the last 3 months.
I can provide my consent and follow the study rules.
You may not be able to join if
I have type 1 diabetes.
I have poor blood sugar control.
I have had diabetic ketoacidosis or severe low blood sugar in the last 6 months.
I have serious heart disease.
I have had pancreatitis or have risk factors for it.
I have a family history of certain types of thyroid cancer.
I have significant liver disease or kidney problems.
I have taken part in another study in the last 30 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
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Eligibility Criteria
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 metformi…
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
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