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Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus

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Hanmi Pharmaceutical

Status and phase

Not yet enrolling
Phase 2

Conditions

Type 2 Diabetes Mellitus
T2DM

Treatments

Drug: HM15275
Drug: Placebo of HM15275

Study type

Interventional

Funder types

Industry

Identifiers

NCT07527650
HM-OBCT-202

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

180 participants in 2 patient groups, including a placebo group

HM15275
Experimental group
Description:
Participants will receive HM15275 via subcutaneous (SC) injection.
Treatment:
Drug: HM15275
Placebo of HM15275
Placebo Comparator group
Description:
Participants will receive placebo of HM15275 via subcutaneous (SC) injection.
Treatment:
Drug: Placebo of HM15275

Trial contacts and locations

2

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Central trial contact

Hyeonho Choi; Pureun Nam

Data sourced from clinicaltrials.gov

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