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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Confirmed as Type 2 Diabetes Mellitus (T2DM) for at least 24 weeks;

• Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5%

• Body Mass Index (BMI within the range of 22.5 \

⁃ 0 kg/m2

Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
Lepeng Li
lilepeng@eastchinapharm.com
+86 18301051549
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 216
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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