Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HM15275, Placebo of HM15275.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus, T2DM. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug HM15275
HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes. - Drug Placebo of HM15275
A sterile, matching solution supplied in pre-filled syringes.
Primary outcome measures
- Change in Glycated Hemoglobin (HbA1c) [Time frame: Up to 41 weeks]
Secondary outcome measures (2)
- Percentage of participants reaching specified HbA1c (%) [Time frame: Up to 41 weeks]
- Number of participants with adverse events (AEs) [Time frame: Up to 41 weeks]
Eligibility criteria
Inclusion criteria
- Participant's age at the time of signing the informed consent:
- United States: 18 to 75 years (inclusive)
- 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
Exclusion criteria
- Type 1 diabetes mellitus or use of glucose-lowering medications other than metformin within 3 months prior to screening
- Poor glycemic control (fasting plasma glucose >270 mg/dL)
- History of diabetic ketoacidosis or severe hypoglycemia within 6 months
- Clinically significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction, stroke, or revascularization within 3 months)
- History of pancreatitis or factors increasing the risk of pancreatitis
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2
- Clinically significant liver disease, renal impairment (eGFR <60 mL/min/1.73 m²), or abnormal laboratory findings at screening
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 14 centers
- Desert Clinical Research — Mesa
- Accel Research Sites - DeLand — DeLand
- Charter Research — Orlando
- AdventHealth Translational Research Institute — Orlando
- Centricity Research IRT - DBA IACT Health Columbus Piedmont — Columbus
- The South Bend Clinic — South Bend
- Jefferson City Medical Center — Jefferson City
- Clay Platte Family Medicine — Kansas City
- … and 6 more centers
Identifiers
NCT: NCT07527650 · HM-OBCT-202