NCT07205900

Study to Evaluate HM15275 in Obese or Overweight Subjects Without 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 Obese or Overweight Subjects Without Diabetes Mellitus

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This Study is a Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Obese or Overweight Subjects Without Diabetes Mellitus.

Detailed description

HM-OBCT-201 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 obese or overweight adults without Type 2 diabetes mellitus (T2DM). The study will enroll adult participants with obesity (body mass index \[BMI\] ≥30 kg/m2 and ≤50 kg/m2) or with overweight (BMI ≥27 kg/m2 and \<30 kg/m2) with at least 1 weight-related comorbidity. Patients with T2DM will be excluded. Participants in this study will be randomly assigned in a 1:1:1:1:1 ratio to 1 of the 5 treatment arms. Randomization will be stratified by sex (female vs male) and BMI (\<35 vs ≥35 kg/m2). All participants will undergo a 6-week screening period, a 36-week treatment period (including the dose-titration phase with weekly subcutaneous \[SC\] injection), and a 4-week safety follow-up period.

Conditions

• Obese
• Obesity

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: 2025-12-02
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-10-03
• Last updated: 2026-04-08

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study