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NCT Number: NCT07109700

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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

Primary outcomes

  1. Change from baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 20

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

Secondary outcomes

  1. Change from baseline in HbA1c

    Time frame: Baseline, Week 12

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

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

    Time frame: Week 20

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

  3. Change frome baseline in fasting plasma glucose (FPG)

    Time frame: Baseline, Week 12 and Week 20

    FPG is a test to determine sugar levels in serum sample after an overnight fast.

  4. Change from baseline in body weight

    Time frame: Baseline, Week 12 and Week 20

    Change from baseline in body weight is calculated by subtracting the baseline weight measurement from the post-treatment weight measurement at a specified time point.

Study contacts

Contact information is provided by the study sponsor or research team.

Lepeng Li

CONTACT

[email protected]

+86 18301051549

Sponsors and collaborators

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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