Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus; T2DM
• Intervention / Treatment: Drug: HM15275; Drug: Placebo of HM15275

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hyeonho Choi; Phone Number: +82-2-410-9834; Email: hyeonho.choi@hanmi.co.kr
• Study Contact Backup: Name: Pureun Nam; Phone Number: +82-2-410-9147; Email: pureun.nam@hanmi.co.kr

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Recruiting
      • Lenzmeier Family Medicine
      • Principal Investigator: Thomas Lenzmeier
    • Mesa, Arizona, United States, 85123
      • Recruiting
      • Desert Clinical Research
      • Principal Investigator: Gerald Shockey
  • Florida
    • Orlando, Florida, United States, 32804
      • Not yet recruiting
      • AdventHealth Translational Research Institute
      • Principal Investigator: Richard Edwin Pratley
  • Indiana
    • South Bend, Indiana, United States, 46617
      • Recruiting
      • The South Bend Clinic
      • Principal Investigator: Rita Schmid
  • Missouri
    • Jefferson City, Missouri, United States, 65109
      • Recruiting
      • Jefferson City Medical Center
      • Principal Investigator: Benjamin Cook
    • Kansas City, Missouri, United States, 64151
      • Recruiting
      • Clay Platte Family Medicine
      • Principal Investigator: Scott Kuennen
  • Nebraska
    • Fremont, Nebraska, United States, 68025
      • Not yet recruiting
      • Methodist Physicians Clinic
      • Principal Investigator: Thomas Wolf
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Recruiting
      • Santa Rosa Medical Centers of Nevada
      • Principal Investigator: Syed Pervaiz
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Not yet recruiting
      • Lucas Research, Inc.
      • Principal Investigator: Kathryn Jean Lucas
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Recruiting
      • Olympus Family Medicine
      • Principal Investigator: Jared Probst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HM15275; Participants will receive HM15275 via subcutaneous (SC) injection.	Drug: HM15275; HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.
Placebo Comparator: Placebo of HM15275; Participants will receive placebo of HM15275 via subcutaneous (SC) injection.	Drug: Placebo of HM15275; A sterile, matching solution supplied in pre-filled syringes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated Hemoglobin (HbA1c)	Change in HbA1c (%) from randomization to Week 37.	Up to 41 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs)	Number of participants with adverse events (AEs) after multiple subcutaneous (SC) doses.	Up to 41 weeks
Percentage of participants reaching specified HbA1c (%)	Percentage of participants reaching specified high, medium, and low HbA1c (%) after multiple subcutaneous (SC) doses.	Up to 41 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration profile	Plasma concentration profile of HM15275 after multiple subcutaneous (SC) doses.	Up to 41 weeks

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: T2DM; Type 2 Diabetes Mellitus
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HM-OBCT-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No