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Clinical Trials in China / NCT07417306
Starting soon Phase 3

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 · tracked via the Priya Life Science China tracker
Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Phase
Phase 3
Started
2026-03-27
Last updated
2026-02-18

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

HDM1005 1HDM1005 2Mazdutide

HDM1005 1: administered SC, QW, 52 week

HDM1005 2: administered SC, QW, 52 week

Mazdutide: administered SC, QW, 52 week

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Hemoglobin A1c (HbA1c) ≥7.5% and ≤11.0% (local laboratory) at screening; and ≥7.0% and ≤11.0% (central laboratory) at randomization. 3. Body Mass Index (BMI) ≥22.5 kg/m2. Exclusion Criteria: 1. Other types of diabetes besides T2DM. 2. 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). 3. History of a level 3 hypoglycemic episode or a history of asymptomatic hyp oglycemic episodes within 24 weeks prior to signing the ICF. 4. History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2). 5. 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. 6. 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. 7. 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. 8. Hemoglobin (Hb) \<100 g/L (female) or \<110 g/L (male). 9. FPG ≥13.9 mmol/L. 10. Aspartate aminotransferase (AST) \>3× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3× ULN. 11. Total bilirubin \>1.5× ULN. 12. Fasting triglyceride (TG) \>5.6 mmol/L (500 mg/dL).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing China

More Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07417306 on ClinicalTrials.gov ↗ ← All trials in China