NCT07527650 Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus
| NCT ID | NCT07527650 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hanmi Pharmaceutical Company Limited |
| Condition | Type 2 Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2026-05-18 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 180 participants in total. It began in 2026-05-18 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07527650 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Type 2 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07527650 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07527650 currently recruiting?
Yes, NCT07527650 is actively recruiting participants. Contact the research team at pureun.nam@hanmi.co.kr for enrollment information.
Where is the NCT07527650 trial being conducted?
This trial is being conducted at Glendale, United States, Mesa, United States, Orlando, United States, South Bend, United States and 6 additional locations.
Who is sponsoring the NCT07527650 clinical trial?
NCT07527650 is sponsored by Hanmi Pharmaceutical Company Limited. The trial plans to enroll 180 participants.
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