Phase 2 Type 2 Diabetes Trial, Recruiting NCT07303803 Sponsor: Shanghai Jiao Tong University School of Medicine Condition: Type 2 Diabetes
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Phase 2 Type 2 Diabetes Trial, Recruiting

NCT07303803
Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • Adults aged 18 to 75 years old at the time of giving consent
  • People who have been diagnosed with type 2 diabetes and have a blood sugar control reading (HbA1c) of 9.5% or below at screening
  • People whose liver scan (Fibroscan) shows specific results indicating liver fat and liver stiffness above certain levels (confirm with trial site)
  • People who have been diagnosed with a liver condition called MASH (metabolic dysfunction-associated steatohepatitis) confirmed by a liver biopsy, with the biopsy showing a certain level of liver damage and scarring — the biopsy must have been done no more than 6 months before screening
  • People whose body weight has been stable (changed by no more than 10%) for at least 3 months before joining
  • People who are able to understand the trial requirements and take medication daily as directed
  • People who are willing to sign a consent form agreeing to take part

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who drink more than a moderate amount of alcohol daily (more than 20g per day for women, or more than 40g per day for men)
  • People who have another form of chronic liver disease, such as alcoholic liver disease, hepatitis B, hepatitis C, autoimmune liver disease, drug-induced liver disease, liver cancer, or any other liver condition besides MASH
  • People whose type 2 diabetes is not well controlled (HbA1c above 9.5% at screening), or people who have type 1 diabetes
  • People with type 2 diabetes who have a history of a serious diabetes complication, including diabetic ketoacidosis or certain eye conditions caused by diabetes
  • People who have had a heart attack, stroke, unstable chest pain, or a hospitalisation for heart failure within the 6 months before screening, or who have severe heart failure
  • People who have had a significant cancer diagnosis within the last 5 years, or whose cancer is not yet in remission (some minor skin cancers and early-stage cancers may be exceptions — confirm with trial site)
  • People with uncontrolled high blood pressure at or above certain levels (confirm with trial site)
  • People with significantly reduced kidney function below a certain level (confirm with trial site)
  • People with a known serious stomach-emptying disorder, such as severe diabetic gastroparesis, or who regularly take medications that affect how the digestive system moves food
  • People who have a personal or close family history of certain rare hormonal or thyroid conditions, including a type of thyroid cancer called medullary thyroid carcinoma
  • People with an untreated thyroid condition (either underactive or overactive thyroid)
  • People who have received an organ transplant (corneal eye transplants are allowed) or who are waiting for a transplant
  • Women who are pregnant, who test positive for pregnancy during screening, who are breastfeeding, or who are unwilling to use effective contraception during the trial
  • People who have taken certain medications known to cause fat build-up in the liver (such as amiodarone, methotrexate, or tamoxifen) for more than 2 weeks in the 3 months before screening
  • People currently taking medication known to cause weight gain, unless the dose has been stable for at least 3 months before screening and will remain stable during the trial
  • People who have been taking steroid medications (taken throughout the body, not just on the skin) for more than 2 weeks within the 3 months before screening
  • People who have recently used certain treatments specifically targeting MASH (including a class of diabetes/weight medications called GLP-1 receptor agonists) for more than 2 weeks in the 3 months before screening
  • People with any other condition that, in the opinion of the trial doctor, would make it difficult to complete the trial

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 31 July 2026

Contact this trial

Principal Investigator: Hai Li, professor, Shanghai Punan Hospital of Pudong New District (Punan Branch of Renji Hospital, Shanghai Jiaotong University School of Medicine)

Phone: +86 13818525494

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Shanghai Jiao Tong University School of Medicine
Registry
ClinicalTrials.gov
Start date
1 January 2026
Est. completion
1 December 2030

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Percentage of participants with resolution of steatohepatitis and no worsening of liver fibrosis

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: 31 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