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

NCT07394114 | Recruiting Phase 3

• 1 other identifier: HDM1005-302
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

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 36

Secondary Outcomes (4)

• Change from baseline in HbA1c

  Baseline, Week 52

• The percentage of patients reaching the HbA1c targets of <7.0%, ≤6.5%, and <5.7%

  Week 36, Week 52

• Change from baseline in fasting plasma glucose (FPG)

  Baseline, Week 36, Week 52

• Change from baseline in body weight

  Baseline, Week 36, Week 52

Study Arms (3)

HDM1005 1

EXPERIMENTAL

HDM1005 administered subcutaneously (SC).

Drug: HDM1005 1

HDM1005 2

EXPERIMENTAL

HDM1005 administered SC.

Drug: HDM1005 2

Placebo

PLACEBO COMPARATOR

administered SC.

Drug: HDM1005 injection or placebo

Interventions

HDM1005 1 DRUG

administered SC, QW, 52 weeks.

HDM1005 1

HDM1005 2 DRUG

administered SC, QW, 52 weeks.

HDM1005 2

HDM1005 injection or placebo DRUG

administered SC, QW, 52 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 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 12 weeks and have not used any antihyperglycemic medications during for at least 12 weeks prior to screening.
• Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5% at screening; and ≥7.0% and ≤10.5% at randomization.
• Body Mass Index (BMI) ≥22.5 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-ketoticcoma) occurred within 24 weeks prior to signing the Informed Consent Form (ICF).
• History of a level 3 hypoglycemic episode or a history of asymptomatic hypoglycemic 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 requiring treatment per investigator's assessment 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 any antidiabetic medications within 12 weeks prior to signing the ICF; excluding short-term insulin use (cumulative duration ≤7 days) for concomitant illness, stress, or perioperative periods.
• Hemoglobin (Hb) \<100 g/L (female) or \<110 g/L (male).
• FPG ≥13.9 mmol/L.
• Aspartate aminotransferase (AST) \>3× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3× 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)

Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wenyan Cao

CONTACT

+86 18810614389; cxycaowenyan@eastchinapharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 6, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): August 28, 2027
• Study Completion (Estimated): December 17, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

CN (1)