Actively Recruiting
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
Led by Hanmi Pharmaceutical Company Limited · Updated on 2026-05-26
180
Participants Needed
10
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, safety, and tolerability of HM15275 in adults with type 2 diabetes mellitus (T2DM) who have inadequate blood sugar control. This Phase 2 study focuses on adults aged 18 to 75 years with a body mass index between 25 and 50 kg/m² and HbA1c levels between 7.0% and 10.0%. The study aims to assess whether HM15275 can improve blood sugar levels over 36 weeks compared to a placebo. Participants will be randomly assigned to one of four groups, receiving either HM15275 or a placebo via weekly subcutaneous injections during the 36-week treatment period. Before treatment, all participants will complete a 4-week screening phase to confirm eligibility. After the treatment period, there will be a 4-week safety follow-up to monitor any side effects or health changes. During the study, participants will have regular visits to monitor their blood sugar levels using glycated hemoglobin (HbA1c) tests, assess safety through reports of adverse events, and evaluate overall treatment effects. The total participation lasts 44 weeks, including screening, treatment, and follow-up. Researchers will carefully track changes in HbA1c and any side effects to understand the treatment’s impact.
CONDITIONS
Brief Title
Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at the time of informed consent
- Diagnosed with type 2 diabetes mellitus with HbA1c between 7.0% and 10.0% at screening
- Treated with diet and exercise alone or stable metformin dose (≥1000 mg/day) for at least 3 months before screening
- Body mass index (BMI) between 25 and 50 kg/m²
- Body weight change less than 5% in the 3 months prior to screening
- Able to give informed consent and willing to follow study procedures
You will not qualify if you...
- Diagnosis of type 1 diabetes or use of glucose-lowering drugs other than metformin within 3 months before screening
- Poor blood sugar control with fasting plasma glucose over 270 mg/dL
- History of diabetic ketoacidosis or severe hypoglycemia in the past 6 months
- Significant cardiovascular disease such as advanced heart failure, recent heart attack, stroke, or revascularization within 3 months
- History or risk factors for pancreatitis
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Significant liver disease, kidney impairment (eGFR less than 60 mL/min/1.73 m²), or abnormal lab results at screening
- Participation in another investigational study within 30 days or longer if related to GLP-1 receptor agonists or weight loss treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 36 weeks
Participants receive weekly subcutaneous injections of the study drug or placebo for 36 weeks to evaluate efficacy, safety, and tolerability.
Weekly visits for dosing and assessments
Duration - 4 weeks
Participants are monitored for safety after treatment ends.
1 follow-up visit
Trial Site Locations
Total: 10 locations
1
Lenzmeier Family Medicine
Glendale, Arizona, United States, 85308
Actively Recruiting
2
Desert Clinical Research
Mesa, Arizona, United States, 85123
Actively Recruiting
3
AdventHealth Translational Research Institute
Orlando, Florida, United States, 32804
Not Yet Recruiting
4
The South Bend Clinic
South Bend, Indiana, United States, 46617
Actively Recruiting
5
Jefferson City Medical Center
Jefferson City, Missouri, United States, 65109
Actively Recruiting
6
Clay Platte Family Medicine
Kansas City, Missouri, United States, 64151
Actively Recruiting
7
Methodist Physicians Clinic
Fremont, Nebraska, United States, 68025
Not Yet Recruiting
8
Santa Rosa Medical Centers of Nevada
Las Vegas, Nevada, United States, 89119
Actively Recruiting
9
Lucas Research, Inc.
Morehead City, North Carolina, United States, 28557
Not Yet Recruiting
10
Olympus Family Medicine
Salt Lake City, Utah, United States, 84117
Actively Recruiting
Research Team
P
Pureun Nam
H
Hyeonho Choi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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