NCT07109700

A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin

A Randomized, Double-blind, Placebo and Active Comparator-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HDM1005 in Subjects With T2DM With Inadequate Glycemic Control After Diet/Exercise or Metformin Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind (with open-label dose levels and active comparator), parallel-group, placebo- and active-controlled Phase 2 clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic (PK) characteristics of HDM1005 in subjects with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control after diet/exercise or metformin therapy. A total of 216 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \>8.5%) and prior metformin use, then randomized 1:1:1:1:1:1 to: Group 1 (HDM1005 0.5 mg), Group 2 (HDM1005 1.0 mg), Group 3 (HDM1005 2.0 mg), Group 4 (HDM1005 3.0 mg), Group 5 (Placebo), and Group 6 (open-lable dulaglutide 1.5 mg, active comparator), with 36 subjects in each treatment group. Within each dose cohort (0.5/1.0/2.0/3.0mg), there will be \~45 total subjects (36 HDM1005 + 9 placebo). The 1.0mg, 2.0mg, and 3.0mg cohorts will implement dose titration. The study consists of: 2-week screening, 20-week treatment, and 4-week safety follow-up. 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, 20 weeks
DRUG	HDM1005 2	administered SC, QW, 20 weeks
DRUG	HDM1005 3	administered SC, QW, 20 weeks
DRUG	HDM1005 4	administered SC, QW, 20 weeks
DRUG	Placebo	administered SC, QW, 20 weeks
DRUG	Dulaglutide 1.5 MG	administered SC, QW, 20 weeks

Timeline

• Start date: 2025-04-30
• Primary completion: 2026-01-31
• Completion: 2026-02-28
• First posted: 2025-08-07
• Last updated: 2025-08-17

Locations

1 site across 1 country: China