RecruitingPhase 3NCT07394114

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

Sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Enrollment

240 participants

Start Date

Feb 24, 2026

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called HDM1005 in people with type 2 diabetes whose blood sugar is not controlled by diet and exercise alone, and who have not been on any diabetes medication for at least 12 weeks. The goal is to see if HDM1005 safely lowers blood sugar levels. **You may be eligible if...** - You have had type 2 diabetes for at least 12 weeks - You have not taken any diabetes medications in the past 12 weeks - Your HbA1c (a 3-month blood sugar average) is between 7.5% and 10.5% at screening - Your BMI is 22.5 or higher **You may NOT be eligible if...** - You have type 1 diabetes or another form of diabetes - You have had a serious low blood sugar episode in the past 6 months - You or a family member has had medullary thyroid cancer or MEN2 syndrome - You have had a heart attack, stroke, or severe heart failure recently - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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