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A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor
A Multicenter, Randomized, Open-label, Parallel-controlled, Phase 3 Study to Compare the Efficacy and Safety of HDM1005 Versus Mazdutide in Subjects With T2DM Inadequate Glycemic Control by Metformin Monotherapy or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor
Assets
HDM1005 / Mazdutide
Listed sites
1
Recruiting sites
—
Enrollment
912
estimated
Study population
Type 2 diabetes
Key I/E criteria
•BMI ≥22.5•HbA1c 7.5-11%
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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).
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointChange from baseline in body weight
Time frame:Baseline, Week 40, Week 52
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
4 endpointsChange from baseline in Hemoglobin A1c (HbA1c)
Time frame:Baseline, Week 40
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change from baseline in HbA1c
Time frame:Baseline, Week 52
HbA1c, change
change from baseline, improvement
LOINC 4548-4
The percentage of patients reaching the HbA1c targets of <7.0%, ≤6.5%, and <5.7%
Time frame:Week 40, Week 52
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Change from baseline in fasting plasma glucose (FPG)
Time frame:Baseline, Week 40, Week 52
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.