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CompletedPhase 2

To Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus

A Phase 2, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of HDM1002 Tablets in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin or Diet and Exercise

Asset

HDM1002

Oral · GLP-1 agonist

Listed sites

31

Recruiting sites

Enrollment

324

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI 22.5-40HbA1c 7.5-10.5%

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

NCT IDNCT06481085
Org study IDHDM1002-202

Timeline

Milestones

Study start2024-06-27actual
Study first posted2024-07-01actual
Primary completion2025-05-30actual
Study completion2025-06-30actual
Last update posted2025-07-28actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male or female subjects between 18 and 75 years of age (inclusive).

2. Have been diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months based on the World Health Organization (WHO 1999) and meets one of the following conditions:

Participants treated with a stable dose of metformin (with maintenance dose of at least 1500 mg/day or a maximally tolerated dose not less than 1000 mg) for at least 6 weeks prior to screening; and must be stable for at least 12 weeks prior to randomization.
Participants on diet and exercise alone for at least 12 weeks prior to screening will be limited to ≤20% of total participant population.

3. HbA1c ≥7.5% and ≤10.5% at screening as assessed by the local laboratory, and HbA1c ≥7.5% and ≤10.5% prior to randomization as assessed by the specified central laboratory.

4. Having a body mass index (BMI) of 22.5 to 40.0 kg/m2, inclusive.

5. Female participants of childbearing potential and male participants must agree to use highly effective contraception method from the day of signing the informed consent form (ICF) and until 30 days (female) or 90 days (male) after the final dose administration.

6. Able to understand and comply with protocol requirements, agree to maintain the same dietary and exercise habits throughout the trial, be willing to complete the trial in strict compliance with the clinical trial protocol and provide written informed consent.

Exclusion criteria

1. Diagnosed with type 1 diabetes mellitus (including latent autoimmune diabetes in adults), special types of diabetes or gestational diabetes mellitus.

2. Evidence of acute complications of diabetes (e.g., diabetic ketoacidosis, diabetic lactosidosis, or hyperosmolar nonketotic coma) within 6 months before signing the ICF.

3. History of level 3 hypoglycemia (as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery) , or history of asymptomatic hypoglycaemic episodes within 6 months prior to signing the ICF.

4. Severe infection within 4 weeks prior to screening and may affect glucose control in the opinion of the investigator.

5. Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2).

6. Evidence of uncontrolled hypothyroidism or hyperthyroidism as judged by the investigator at the time of signing the ICF, or on a stable dose of medication therapy less than 3 months, or having been expected to require dose adjustments throughout the trial.

7. History of acute or chronic pancreatitis, or any high-risk factor which may lead to pancreatitis; or have symptomatic gallbladder disease within 6 months before signing the ICF.

8. Any condition or disease possibly affecting gastric emptying or nutrients absorption in the opinion of the investigator, such as history of bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.

9. Uncontrolled hypertension, defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg under stable treatments of antihypertensive drugs at screening; or previous evidence of renal artery stenosis or unstable blood pressure (including postural hypotension).

10. Have had any of the following within 6 months before signing the ICF:

unstable angina;
heart failure (New York Heart Association, class III or IV);
myocardial infarction (MI);
coronary artery bypass grafting or percutaneous coronary intervention;
Uncontrolled severe arrhythmias (including: ventricular tachycardia, ventricular fibrillation, atrial fibrillation, second to third degree atrioventricular block, sick sinus node syndrome, pre-excitation syndrome, etc.);
cerebrovascular accident (including stroke or transient ischemic attack).

11. Have a history of proliferative diabetic retinopathy and/or diabetic maculopathy, or evidence of other severe retinopathy that requires immediate treatment intervention.

12. Have a known history of liver disease, including: acute or chronic active liver disease (except non-alcoholic steatohepatitis) such as active hepatitis B, hepatitis C; or primary biliary cholangitis.

13. Have evidence of a significant, active autoimmune abnormality (for example, lupus or rheumatoid arthritis) that, in the opinion of the investigator, requires concurrent treatment with systemic glucocorticoids during the trial.

14. Evidence of any malignancy with 5 years before signing the ICF (except for basal cell carcinoma that has received curative treatment and is considered cured).

15. Self-reported or documented change in body weight of ≥5% within 3 months before signing the ICF.

16. Having used a Glucagon-like peptide-1 (GLP-1) analogue within 6 months prior to signing the ICF; or previous discontinuation of a GLP-1 analogue due to safety/tolerability or lack of efficacy.

17. Estimated glomerular filtration rate (eGFR) < 45 mL/min.

18. Positive result on HBsAg, anti-hepatitis C virus (HCV) antibodies, anti-immunodeficiency virus (HIV) antibodies, or a positive test result for antibodies to syphilis spirochetes.

19. History of alcohol abuse (i.e., drinking more than 14 standard units of alcohol per week for men and 7 standard units of alcohol per week for women, with 1 standard unit containing 14 g of alcohol, such as 360 mL of beer or 45 mL of spirits with alcohol content of 40% or 150 mL of wine) or drug addiction within one year before signing the ICF; or presence of a psychiatric disorder that, in the opinion of the investigator, could interfere with participation in the study (e.g., depression).

20. Pregnancy or lactation.

21. Known allergy to any components of the investigational drug, metformin or its excipients.

22. Have any of the following conditions: an investigator or sub-investigator, or a research assistant, or a pharmacist, or a study coordinator, or other staff member directly involved in the study, or any person who is dependent on the study site, the investigator, or the sponsor (such as employees or their immediate family member).

23. Enrolled in or participated in any other clinical study within 3 months (or within 5 times the elimination half-life, whichever is longer) prior to signing the ICF (except for subjects who signed written informed consent without any intervention of investigational product).

24. Any other condition considered by the investigator which is not suitable for participating in this study.

Endpoints (16)

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

Glycemic / diabetes
8
Weight & body composition
3
Safety / tolerability / PK
3
Cardiometabolic biomarkers
2

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Weight Loss ≥ 5% and ≥ 10%

Time frame:Baseline, Week 12

≥10% weight-loss responders

threshold achievement, improvement

components≥5% weight-loss responders, ≥10% weight-loss responders

Other/protocol endpoint

Change From Baseline in Body Weight According to Treatment Background ( Metformin or Diet and Exercise Alone)

Time frame:Baseline, Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

8 endpoints
Primary/protocol endpoint

Change From Baseline in HbA1c at Week 12

Time frame:Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in HbA1c at Week 4, Week 8

Time frame:Baseline, Week 4, Week 8

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants With an HbA1c target value of < 7.0% or ≤ 6.5%

Time frame:Baseline, Week 12

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting plasma Glucose

Time frame:Baseline, Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Postprandial 2-hour Glucose (PPG2h), Area Under the Curve of Plasma Glucose (AUC0-4h, Glucose), C-Peptide (AUC0-4h, C-peptide), Insulin (AUC0-4h, Insulin), and Glucagon (AUC0-4h, Glucagon)

Time frame:Baseline, Week 12

change from baseline, improvement

componentsPostprandial glucose, C-peptide AUC

Secondary/protocol endpoint/low confidence

Change From Baseline in Fasting C-Peptide, Fasting Insulin, and Fasting Glucagon

Time frame:Baseline, Week 12

change from baseline, improvement

componentsC-peptide AUC, HOMA-IR (insulin sensitivity), Postprandial glucose

Secondary/protocol endpoint

Change From Baseline in Homeostasis Model Assessment of β-Cell Function (HOMA-β) and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

Time frame:Baseline, Week 12

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Glycaemic Indicators According to Treatment Background ( Metformin or Diet and Exercise Alone)

Time frame:Baseline, Week 12

change from baseline, improvement

componentsHbA1c, change, Fasting glucose, change, Postprandial glucose

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profiles, including: Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Total Cholesterol (TC), Non-HDL-C and Lipoprotein (a) [Lp(a)]

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Systolic and Diastolic Blood Pressure

Time frame:Baseline, Week 12

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]), Adverse Events of Special Interest (AESI), Incidence and Severity of Hypoglycaemic Events, etc.

Time frame:Baseline Through Week 16

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any), Documented hypoglycemia

Secondary/protocol endpoint

Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examination and Electrocardiogram

Time frame:Baseline Through Week 16

descriptive

Other/protocol endpoint

Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)

Time frame:Baseline, Day 71

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.