Recruiting
Phase 2

HM15275

Sponsor:

Hanmi Pharmaceutical Company Limited

Code:

NCT07527650

Conditions

Type 2 Diabetes Mellitus

T2DM

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

HM15275

Placebo of HM15275

Study Details

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.

Conditions

Type 2 Diabetes Mellitus

T2DM

Study ID

NCT07527650

Start date

May 18, 2026

Status verified date

Jun, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HM15275

Participants will receive HM15275 via subcutaneous (SC) injection.

placebo comparator: Placebo of HM15275

Participants will receive placebo of HM15275 via subcutaneous (SC) injection.

Interventions

HM15275

HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.

Placebo of HM15275

A sterile, matching solution supplied in pre-filled syringes.

Primary outcome measure

  • Change in Glycated Hemoglobin (HbA1c) [ Time Frame: Up to 41 weeks ]

Central Contacts and Locations

Locations

Desert Clinical Research

Recruiting

Mesa, Arizona, United States, 85123

Principal Investigator:

Gerald Shockey

Accel Research Sites - DeLand

Recruiting

DeLand, Florida, United States, 32720

Principal Investigator:

Bruce Rankin

Charter Research

Recruiting

Orlando, Florida, United States, 32803

Principal Investigator:

Mary Hilal Quarterman

K2 Medical Research The Villages LLC

Recruiting

The Villages, Florida, United States, 32159

Principal Investigator:

Craig T Curtis

Centricity Research IRT - DBA IACT Health Columbus Piedmont

Recruiting

Columbus, Georgia, United States, 31904

Principal Investigator:

Steven Leichter

The South Bend Clinic

Recruiting

South Bend, Indiana, United States, 46617

Principal Investigator:

Rita Schmid

Jefferson City Medical Center

Recruiting

Jefferson City, Missouri, United States, 65109

Principal Investigator:

Benjamin Cook

Clay Platte Family Medicine

Recruiting

Kansas City, Missouri, United States, 64151

Principal Investigator:

Scott Kuennen

Methodist Physicians Clinic

Recruiting

Fremont, Nebraska, United States, 68025

Principal Investigator:

Thomas Wolf

Santa Rosa Medical Centers of Nevada

Recruiting

Las Vegas, Nevada, United States, 89119

Principal Investigator:

Syed Pervaiz

Lucas Research, Inc.

Recruiting

Morehead City, North Carolina, United States, 28557

Principal Investigator:

Kathryn Jean Lucas

Centricity Research Columbus

Recruiting

Columbus, Ohio, United States, 43213

Principal Investigator:

Sridhar Guduri

Olympus Family Medicine

Recruiting

Salt Lake City, Utah, United States, 84117

Principal Investigator:

Jared Probst

Manassas Clinical Research Center

Recruiting

Manassas, Virginia, United States, 20110

Principal Investigator:

Nabil Saleh Andrawis

More Information

Sponsor

Hanmi Pharmaceutical Company Limited

Last update posted

Aug 17, 2026

Last verified

Jun, 2026

Keywords

  • Type 2 Diabetes Mellitus
  • T2DM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hanmi Pharmaceutical Company Limited on 2026-08-17.