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

NCT07394114 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-02-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-24
Primary Completion
2027-08-28
Completion
2027-12-17

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07394114 on ClinicalTrials.gov