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Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus

RecruitingPhase 2

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Subjects With Type 2 Diabetes Mellitus

Who can join

Ages 18 to 75 · All sexes

Full 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

About the 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.

What is being tested

Sponsor: Hanmi Pharmaceutical Company Limited · Participants: 180 · Started: May 18, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07527650

Locations in the U.S.

ArizonaDesert Clinical Research, Mesa
FloridaAccel Research Sites - DeLand, DeLand
AdventHealth Translational Research Institute, Orlando (Not yet recruiting)
Charter Research, Orlando
K2 Medical Research The Villages LLC, The Villages
GeorgiaCentricity Research IRT - DBA IACT Health Columbus Piedmont, Columbus
IndianaThe South Bend Clinic, South Bend
MissouriJefferson City Medical Center, Jefferson City
Clay Platte Family Medicine, Kansas City
NebraskaMethodist Physicians Clinic, Fremont
NevadaSanta Rosa Medical Centers of Nevada, Las Vegas
North CarolinaLucas Research, Inc., Morehead City
OhioCentricity Research Columbus, Columbus
UtahOlympus Family Medicine, Salt Lake City
VirginiaManassas Clinical Research Center, Manassas

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.