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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM15275 | Experimental | Participants will receive HM15275 via subcutaneous (SC) injection. |
|
| Placebo of HM15275 | Placebo Comparator | Participants will receive placebo of HM15275 via subcutaneous (SC) injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM15275 | Drug | HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Hemoglobin (HbA1c) | Change in HbA1c (%) from randomization to Week 37. | Up to 41 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of participants with adverse events (AEs) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration profile | Plasma concentration profile of HM15275 after multiple subcutaneous (SC) doses. | Up to 41 weeks |
Key Inclusion Criteria
Participant's age at the time of signing the informed consent:
Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening
Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for at least 3 months prior to screening
BMI ≥25 kg/m² and ≤50 kg/m²
Body weight change <5% over the past 3 months prior to screening
Capable of giving signed informed consent and willing to comply with all protocol procedures
Key Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pureun Nam | Contact | +82-2-410-9147 | pureun.nam@hanmi.co.kr | |
| Hyeonho Choi | Contact | +82-2-410-9834 | hyeonho.choi@hanmi.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Clinical Research | Recruiting | Mesa | Arizona | 85123 | United States |
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| Placebo of HM15275 | Drug | A sterile, matching solution supplied in pre-filled syringes. |
|
Number of participants with adverse events (AEs) after multiple subcutaneous (SC) doses.
| Up to 41 weeks |
| Charter Research | Recruiting | Orlando | Florida | 32803 | United States |
|
| AdventHealth Translational Research Institute | Not yet recruiting | Orlando | Florida | 32804 | United States |
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| Centricity Research IRT - DBA IACT Health Columbus Piedmont | Recruiting | Columbus | Georgia | 31904 | United States |
|
| The South Bend Clinic | Recruiting | South Bend | Indiana | 46617 | United States |
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| Jefferson City Medical Center | Recruiting | Jefferson City | Missouri | 65109 | United States |
|
| Clay Platte Family Medicine | Recruiting | Kansas City | Missouri | 64151 | United States |
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| Methodist Physicians Clinic | Recruiting | Fremont | Nebraska | 68025 | United States |
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| Santa Rosa Medical Centers of Nevada | Recruiting | Las Vegas | Nevada | 89119 | United States |
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| Lucas Research, Inc. | Recruiting | Morehead City | North Carolina | 28557 | United States |
|
| Centricity Research Columbus | Recruiting | Columbus | Ohio | 43213 | United States |
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| Olympus Family Medicine | Recruiting | Salt Lake City | Utah | 84117 | United States |
|
| Manassas Clinical Research Center | Recruiting | Manassas | Virginia | 20110 | United States |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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