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

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study ID
NCT07109700
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • HDM1005 1 — DRUG
    administered SC, QW, 20 weeks
  • HDM1005 2 — DRUG
    administered SC, QW, 20 weeks
  • HDM1005 3 — DRUG
    administered SC, QW, 20 weeks
  • HDM1005 4 — DRUG
    administered SC, QW, 20 weeks
  • Placebo — DRUG
    administered SC, QW, 20 weeks
  • Dulaglutide 1.5 MG — DRUG
    administered SC, QW, 20 weeks

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
Mar 2025
Primary completion
Jan 31, 2026
Completion
Feb 28, 2026

Study Design

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

Arms

  • Experimental: Experimental group: HDM1005 1
    HDM1005 administered subcutaneously (SC)
  • Experimental: Experimental group: HDM1005 2
    HDM1005 administered SC
  • Experimental: Experimental group: HDM1005 3
    HDM1005 administered SC
  • Experimental: Experimental group: HDM1005 4
    HDM1005 administered SC
  • Placebo Comparator: Placebo group
    Placebo administered SC
  • Active Comparator: Active Comparator: Dulaglutide
    Dulagutide administered SC

Primary Outcome Measure

Change from baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 20 ]

Central Contacts

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