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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Study to Evaluate HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus

A Phase 3, 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 With Diet and Exercise Only

Study to Evaluate HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus (NCT07193459) is a Phase 3 interventional studying Type 2 Diabetes, sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets in adults with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise only

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Type 2 Diabetes, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 360 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 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 10 weeks based on the World Health Organization, and meet the following conditions:a) had been treated with diet and exercise for at least 10 weeks prior to signing ICF; b) Not been treated with any hypoglycemic drugs within 10 weeks prior to signing ICF. 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 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 willing to sign a consent form. Who Should NOT Join This Trial: 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 prior to signing ICF. 3. Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2) 4. History of acute or chronic pancreatitis or pancreatic injury, or any high-risk factor which may lead to pancreatitis; or have symptomatic gallbladder disease that requires treatment during the trial (subjects with prior cholecystectomy can be enrolled if deemed eligible by the investigator) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 10 weeks based on the World Health Organization, and meet the following conditions:a) had been treated with diet and exercise for at least 10 weeks prior to signing ICF; b) Not been treated with any hypoglycemic drugs within 10 weeks prior to signing ICF. 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 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 prior to signing ICF. 3. Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2) 4. History of acute or chronic pancreatitis or pancreatic injury, or any high-risk factor which may lead to pancreatitis; or have symptomatic gallbladder disease that requires treatment during the trial (subjects with prior cholecystectomy can be enrolled if deemed eligible by the investigator) 5. Have had dysphagia, or any condition or disease possibly affecting gastric emptying or nutrients absorption in the opinion of the investigator, such as history of surgery affecting gastric emptying, gastroesophageal reflux disease, pyloric obstruction, irritable bowel syndrome, etc. 6. Have had any of the following within 3 months prior to screening: * 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 7. Have a history of proliferative diabetic retinopathy and/or diabetic maculopathy that requires treatment, or evidence of other severe retinopathy that requires treatment during the study. 8. 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. 9. Those who have used the following drugs within 14 days before randomization or within 5 half-lives (whichever is longer), or who need to use the following drugs for a long time during the trial, are excluded: strong or moderate inhibitors of cytochrome P450 enzyme (CYP) 3A4, strong inducers of CYP3A4, strong inhibitors of P-gp, strong inducers of P-gp, inhibitors of OATP1B1 or OATP1B3, or narrow therapeutic index drugs that are CYP2C8, CYP3A4, UGT1A1, P-gp, OATP1B1 or OATP1B3 substrates. 10. Use of any glucose-lowering medication within 10 weeks prior to signing ICF, including but not limited to: α-glucosidase inhibitors (e.g., acarbose), thiazolidinediones, and dipeptidyl peptidase-4 inhibitors (DPP-4i) inhibitors, glucose kinase activators, sodium-glucose cotransporter-2 inhibitors (SGLT-2i) ,with the exception of short-term insulin therapy due to a concomitant illness, stress, or perioperative period (cumulative duration ≤ 14 days). 11. Having used a Glucagon-like peptide-1 (GLP-1) analogue within 3 months prior to signing the ICF; or previous discontinuation of a GLP-1 analogue due to safety/tolerability or lack of efficacy. 12. Pregnancy or lactation. 13. Subjects with a known hypersensitivity to GLP-1 receptor agonists (GLP-1RA), or a history of severe drug allergies. 14. Enrolled in or participated in any other clinical study of drugs or medical devices within 3 months (or within 5 half-lives, whichever is longer) prior to signing the ICF (except for subjects who signed written informed consent without any intervention of investigational product or medical devices). 15. Any other condition considered by the investigator which is not suitable for participating in this study.

Treatments Being Tested

DRUG

HDM1002 200 mg

HDM1002 tablets, 200 mg once daily

DRUG

HDM1002 400 mg

HDM1002 tablets, 400 mg once daily

DRUG

Placebo

Placebo tablets, once daily

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking University People's Hospital
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07193459), the sponsor (Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07193459 clinical trial studying?

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets in adults with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise only The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07193459?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07193459?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07193459. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07193459. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.