Phase 2 Study of HM15275 Injections for 36 Weeks in Adults With Type 2 Diabetes Mellitus to Assess Effectiveness, Safety, and Tolerability

What this Trial Is About

Researchers are evaluating HM15275 in adults with type 2 diabetes mellitus who have inadequate blood sugar control. This Phase 2 clinical trial aims to assess the effectiveness, safety, and tolerability of HM15275 compared to a placebo over 36 weeks. Participants must be between 18 and 75 years old, have a body mass index between 25 and 50 kgm, and have specific blood sugar levels measured by HbA1c between 7.0% and 10.0%. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will be randomly assigned to one of four groups, receiving either HM15275 or a placebo via weekly subcutaneous injections. The study includes a 4-week screening period to confirm eligibility, followed by a 36-week treatment phase where participants receive the injections. After the treatment phase, there is a 4-week safety follow-up to monitor any effects after stopping the medication. Randomization considers factors like initial HbA1c levels and whether participants are using metformin. Throughout the study, participants will attend regular visits for assessments. Researchers will measure changes in HbA1c to determine blood sugar control, track the percentage of participants reaching target HbA1c levels, and monitor any adverse events. Safety and tolerability are closely observed during the treatment and follow-up periods. The total participation time is approximately 44 weeks, including screening, treatment, and safety follow-up.

Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus