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

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study ID
NCT07394114
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Feb 6, 2026
Start date
Feb 24, 2026
Status verified
Feb 2026
Primary completion
Aug 28, 2027
Completion
Dec 17, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HDM1005 1
    HDM1005 administered subcutaneously (SC).
  • Experimental: HDM1005 2
    HDM1005 administered SC.
  • Placebo Comparator: Placebo
    administered SC.

Primary Outcome Measure

Change from baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 36 ]

Central Contacts

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