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Trial · Interventional

Not yet recruitingPhase 3Registry data

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

NCTNCT07417306 (opens ClinicalTrials.gov in a new tab)Other idHDM1005-303
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 3
Enrollment
912 participants (estimated)
Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
27 Mar 2026 (estimated)
Primary completion
30 Aug 2027 (estimated)
Completion
31 Dec 2027 (estimated)
First posted
18 Feb 2026
Last update posted
18 Feb 2026
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 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

    est. 27 Mar 2026 to est. 31 Dec 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • HDM1005 1Drug
  • HDM1005 2Drug
  • MazdutideDrug

Arms3

  • Experimental

    Experimental group: HDM1005 1

    HDM1005 administered subcutaneously (SC)

  • Experimental

    Experimental group: HDM1005 2

    HDM1005 administered SC

  • Active comparator

    Active Comparator: Mazdutide

    Mazdutide administered SC

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from baseline in Hemoglobin A1c (HbA1c)

    Time frame · Baseline, Week 40

    Registry description

    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(4)

  1. Change from baseline in HbA1c

    Time frame · Baseline, Week 52

    Registry description

    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 targets of <7.0%, ≤6.5%, and <5.7%

    Time frame · Week 40, Week 52

    Registry description

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

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

    Time frame · Baseline, Week 40, Week 52

    Registry description

    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 40, Week 52

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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