A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor

NCT07417306 | Not Yet Recruiting Phase 3

• 1 other identifier: HDM1005-303
• Study Type: interventional
• Target: 912
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, randomized, open-label, parallel-group, phase 3 clinical trial aimed at evaluating the efficacy and safety of HDM1005 versus active comparator in subjects with Type 2 Diabetes Mellitus (T2DM) Inadequate Glycemic Control by Metformin Monotherapy or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor. A total of 912 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \>8.5%) and metformin monotherapy (yes or no), then randomized 1:1:1 to: Group 1 (HDM1005), Group 2 (HDM1005), and Group 3 (active comparator), with 304 subjects in each treatment group. 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, 40-week core treatment, 12-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 40

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 40, Week 52

• Change from baseline in fasting plasma glucose (FPG)

  Baseline, Week 40, Week 52

• Change from baseline in body weight

  Baseline, Week 40, Week 52

Study Arms (3)

Experimental group: HDM1005 1

EXPERIMENTAL

HDM1005 administered subcutaneously (SC)

Drug: HDM1005 1

Experimental group: HDM1005 2

EXPERIMENTAL

HDM1005 administered SC

Drug: HDM1005 2

Active Comparator: Mazdutide

ACTIVE COMPARATOR

Mazdutide administered SC

Drug: Mazdutide

Interventions

HDM1005 1 DRUG

administered SC, QW, 52 week

Experimental group: HDM1005 1

HDM1005 2 DRUG

administered SC, QW, 52 week

Experimental group: HDM1005 2

Mazdutide DRUG

administered SC, QW, 52 week

Active Comparator: Mazdutide

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 on a stable dosage of metformin alone or in combination with an SGLT2 inhibitor for at least 12 weeks prior to screening.
• Hemoglobin A1c (HbA1c) ≥7.5% and ≤11.0% (local laboratory) at screening; and ≥7.0% and ≤11.0% (central laboratory) 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-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 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 antidiabetic medications within 12 weeks prior to signing the ICF, with the exception of metformin monotherapy or combination therapy with an SGLT2 inhibitor; 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)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

mazdutide

Condition Hierarchy (Ancestors)

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

Study Officials

• Linong Ji

  Peking University People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiaying Li

CONTACT

+86 19157709998; lijiaying@eastchinapharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)