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NCT07527650PHASE2Recruiting

Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus

Hanmi Pharmaceutical Company Limited

Start Date

5/18/2026

Completion Date

10/1/2027

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.

Detailed Description

HM-OBCT-202 is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, parallel-group study designed to evaluate the efficacy, safety, and tolerability of HM15275 treatment over 36 weeks in adults with type 2 diabetes mellitus (T2DM). The study will enroll adult participants with T2DM (aged 18 to 75 years) who have inadequate glycemic control. Eligible participants must have a body mass index (BMI) ≥25 kg/m² and ≤50 kg/m² and HbA1c between 7.0% and 10.0% at screening. Participants in this study will be randomly assigned in a 1:1:1:1 ratio to 1 of the 4 treatment arms. Randomization will be stratified by screening HbA1c (≤8.0% versus \>8.0%) and use of metformin (yes versus no). All participants will undergo a 4-week screening period, a 36-week treatment period (including weekly subcutaneous \[SC\] injection of study drug), and a 4-week safety follow-up period.

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

DRUG

HM15275

DRUG

Placebo of HM15275

Interested in This Trial?

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Conditions

Type 2 Diabetes MellitusT2DM

Locations

Desert Clinical Research

Mesa, Arizona 85123

United States

Charter Research

Orlando, Florida 32803

United States

AdventHealth Translational Research Institute

Orlando, Florida 32804

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

Santa Rosa Medical Centers of Nevada

Las Vegas, Nevada 89119

United States

Lucas Research, Inc.

Morehead City, North Carolina 28557

United States

Centricity Research Columbus

Columbus, Ohio 43213

United States

Olympus Family Medicine

Salt Lake City, Utah 84117

United States

Manassas Clinical Research Center

Manassas, Virginia 20110

United States