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

NCT07109700 | Recruiting Phase 2

• 1 other identifier: HDM1005-201
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Hemoglobin A1c (HbA1c)

  HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.

  Baseline, Week 20

Secondary Outcomes (4)

• Change from baseline in HbA1c

  Baseline, Week 12

• The percentage of patients reaching the HbA1c target of ≤6.5% and of ≤7.0%

  Week 20

• Change frome baseline in fasting plasma glucose (FPG)

  Baseline, Week 12 and Week 20

• Change from baseline in body weight

  Baseline, Week 12 and Week 20

Study Arms (6)

Experimental group: HDM1005 1

EXPERIMENTAL

HDM1005 administered subcutaneously (SC)

Drug: HDM1005 1

Experimental group: HDM1005 2

EXPERIMENTAL

HDM1005 administered SC

Drug: HDM1005 2

Experimental group: HDM1005 3

EXPERIMENTAL

HDM1005 administered SC

Drug: HDM1005 3

Experimental group: HDM1005 4

EXPERIMENTAL

HDM1005 administered SC

Drug: HDM1005 4

Placebo group

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Active Comparator: Dulaglutide

ACTIVE COMPARATOR

Dulagutide administered SC

Drug: Dulaglutide 1.5 MG

Interventions

HDM1005 1 DRUG

administered SC, QW, 20 weeks

Experimental group: HDM1005 1

HDM1005 2 DRUG

administered SC, QW, 20 weeks

Experimental group: HDM1005 2

HDM1005 3 DRUG

administered SC, QW, 20 weeks

Experimental group: HDM1005 3

HDM1005 4 DRUG

administered SC, QW, 20 weeks

Experimental group: HDM1005 4

Placebo DRUG

administered SC, QW, 20 weeks

Placebo group

Dulaglutide 1.5 MG DRUG

administered SC, QW, 20 weeks

Active Comparator: Dulaglutide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \~ 40.0 kg/m2

You may not qualify if:

• Other types of diabetes besides T2DM
• Acute complications of diabetes (such as diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic coma) occurred within 24 weeks prior to signing the Informed Consent Form (ICF)
• History of a level 3 hypoglycemic episode or a history of asymptomatic hyp oglycemic episodes within 24 weeks prior to signing the ICF
• History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2)
• History of acute or chronic pancreatitis; or presence of risk factors for pancreatitis; or history of symptomatic gallbladder disease within 24 weeks prior to signing the ICF
• Investigator determines that the subject has a condition or disease affecting gastric emptying or gastrointestinal nutrient absorption, such as weight-loss surgery or other gastric resections, irritable bowel syndrome, dyspepsia, or gastroparesis
• Use of antidiabetic medications within 12 weeks prior to signing the ICF
• Hemoglobin (Hb) \<100 g/L (female) or \<110 g/L (male)
• FPG ≥13.9 mmol/L
• Aspartate aminotransferase (AST) \>2.5× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>2.5× ULN
• Total bilirubin \>1.5× ULN
• Fasting triglyceride (TG) \>5.6 mmol/L (500 mg/dL)

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Lepeng Li

CONTACT

+86 18301051549; lilepeng@eastchinapharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 7, 2025
• Study Start: April 30, 2025
• Primary Completion: January 31, 2026
• Study Completion: February 28, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)