NCT07527650

Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Type 2 Diabetes Mellitus
• T2DM

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-09-01
• Completion: 2027-10-01
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study