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A Study of HDM1005 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
A Multicenter, Randomized, Double-blind, Placebo-Controlled , Phase 3 Study Comparing the Efficacy and Safety of HDM1005 Versus Placebo in Subjects With T2DM Inadequate Glycemic Control With Diet and Exercise Alone
Asset
HDM1005
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
1
Enrollment
240
estimated
Study population
Type 2 diabetes
Key I/E criteria
•BMI ≥22.5•HbA1c 7.5-10.5%
Primary endpoint
•Hemoglobin A1c (HbA1c)
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 have not used any antihyperglycemic medications during for at least 12 weeks prior to screening.
2. Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5% at screening; and ≥7.0% and ≤10.5% 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-ketoticcoma) 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 hypoglycemic 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 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.
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 36, Week 52
change from baseline, improvement
Glycemic / diabetes
4 endpointsChange from baseline in Hemoglobin A1c (HbA1c)
Time frame:Baseline, Week 36
change from baseline, improvement
Change from baseline in HbA1c
Time frame:Baseline, Week 52
change from baseline, improvement
The percentage of patients reaching the HbA1c targets of <7.0%, ≤6.5%, and <5.7%
Time frame:Week 36, Week 52
threshold achievement, improvement
Change from baseline in fasting plasma glucose (FPG)
Time frame:Baseline, Week 36, Week 52
change from baseline, improvement
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.