Phase 3 Type 2 Diabetes Trial, Recruiting NCT07193459 Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Condition: Type 2 Diabetes
Back to Type 2 Diabetes

Phase 3 Type 2 Diabetes Trial, Recruiting

NCT07193459
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 75 years old (inclusive)
  • You have been diagnosed with type 2 diabetes for at least 10 weeks, based on World Health Organization standards
  • For at least 10 weeks before joining, you have been managing your diabetes only through diet and exercise, with no diabetes medications during that time
  • Your HbA1c (a blood sugar control measurement) is between 7.5% and 10.5% at the time of screening and again before being assigned to a treatment group
  • Your body mass index (BMI) is between 22.5 and 40.0 kg/m²
  • If you are a woman who could become pregnant, or a man, you must agree to use highly effective birth control from the time you sign the consent form until 30 days after your last dose (for women) or 90 days after your last dose (for men)
  • You are able to understand the study requirements, keep your diet and exercise habits consistent throughout the trial, follow the study rules strictly, and give written consent to participate

Who may not be able to join:

  • You have been diagnosed with type 1 diabetes, a specific rare type of diabetes, or diabetes that occurred during pregnancy
  • You have had a serious diabetes-related emergency (such as diabetic ketoacidosis or diabetic coma) in the 6 months before joining
  • You or a close family member has a history of a specific type of thyroid cancer (medullary thyroid carcinoma), thyroid cell overgrowth, or a condition called Multiple Endocrine Neoplasia type II (MEN2)
  • You have a history of pancreatitis (inflammation of the pancreas), pancreatic injury, risk factors that could lead to pancreatitis, or gallbladder disease that would need treatment during the trial (confirm with trial site if you have had your gallbladder removed)
  • You have difficulty swallowing, or have a condition that affects how your stomach empties or absorbs nutrients — such as past stomach surgery, acid reflux disease, a blocked stomach outlet, or irritable bowel syndrome
  • In the 3 months before screening, you have experienced unstable chest pain (angina), severe heart failure, a heart attack, heart bypass surgery or a stent procedure, serious uncontrolled heart rhythm problems, or a stroke
  • You have advanced diabetic eye disease affecting the retina or the central part of the eye (macula) that requires treatment, or other severe eye conditions needing treatment during the study
  • You have a known history of liver disease, including active hepatitis B, hepatitis C, or a condition called primary biliary cholangitis (non-alcoholic fatty liver disease is not automatically excluded — confirm with trial site)
  • You have recently used, or need to continue using, certain medications that affect how the body processes drugs (specific enzyme and transport protein inhibitors or inducers) — (confirm specific medications with trial site)
  • You have used any blood sugar–lowering medication in the 10 weeks before joining, including tablets such as acarbose, thiazolidinediones, DPP-4 inhibitors, glucose kinase activators, or SGLT-2 inhibitors (short-term insulin use of 14 days or less due to illness or surgery may be an exception — confirm with trial site)
  • You have used a GLP-1 analogue (a type of diabetes injection medication) in the 3 months before joining, or you previously stopped using one because it did not work or caused problems
  • You are currently pregnant or breastfeeding
  • You have a known allergy to GLP-1 receptor agonist medications, or a history of severe drug allergies
  • You have taken part in another clinical drug or medical device trial within the past 3 months (or within 5 half-lives of that drug, whichever is longer)
  • The trial doctor believes there is any other reason you should not participate (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
12 August 2025
Est. completion
10 October 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Change From Baseline in HbA1c at Week 40

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov