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
Hanmi Pharmaceutical Company Limited
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.
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. Randomiza…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 me…
Interventions
- DrugHM15275
HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.
- DrugPlacebo of HM15275
A sterile, matching solution supplied in pre-filled syringes.
Locations (2)
- AdventHealth Translational Research InstituteOrlando, Florida
- Lucas Research, Inc.Morehead City, North Carolina