T2DM, Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, T2DM
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.
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.
Interventions
DRUGHM15275
HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.
A sterile, matching solution supplied in pre-filled syringes.
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated Hemoglobin (HbA1c) | Up to 41 weeks | Change in HbA1c (%) from randomization to Week 37. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants reaching specified HbA1c (%) | Up to 41 weeks | Percentage of participants reaching specified high, medium, and low HbA1c (%) after multiple subcutaneous (SC) doses. |
| Number of participants with adverse events (AEs) | Up to 41 weeks | Number of participants with adverse events (AEs) after multiple subcutaneous (SC) doses. |
Countries
United States
Contacts
CONTACTPureun Nam
CONTACTHyeonho Choi
Outcome results
None listed