NCT07394114

A Study of HDM1005 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

A Multicenter, Randomized, Double-blind, Placebo-Controlled , Phase 3 Study Comparing the Efficacy and Safety of HDM1005 Versus Placebo in Subjects With T2DM Inadequate Glycemic Control With Diet and Exercise Alone

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled , phase 3 clinical trial aimed at evaluating the efficacy and safety of HDM1005 versus placebo in subjects with T2DM inadequate glycemic control with diet and exercise alone. A total of 240 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \>8.5%) , then randomized 1:1:1 to: Group 1 (HDM1005), Group 2 (HDM1005), and Group 3 (placebo), with 80 subjects in each treatment group. At week 36, subjects in placebo group will receive HDM1005 injection until week 52. All treatment groups will implement dose titration to achieve the target dose. The study consists of: up to 2-week screening, 2-week run-in, 36-week core treatment, 16-week extension treatment, and 4-week follow-up, totaling 60 weeks. The end-of-study visit will be conducted 28 days after the last administration cycle.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	HDM1005 1	administered SC, QW, 52 weeks.
DRUG	HDM1005 2	administered SC, QW, 52 weeks.
DRUG	HDM1005 injection or placebo	administered SC, QW, 52 weeks.

Timeline

• Start date: 2026-02-24
• Primary completion: 2027-08-28
• Completion: 2027-12-17
• First posted: 2026-02-06
• Last updated: 2026-02-09

Locations

1 site across 1 country: China