Printed from Voxsanity (voxsanity.com.au) — NCT07653477 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Type 2 Diabetes Trial, Not Yet Recruiting
NCT07653477
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
- People aged 18 to 75 years at the time of signing the consent form, of any gender.
- People who have been diagnosed with Type 2 Diabetes according to 2019 World Health Organization (WHO) standards, with a blood sugar control measure called HbA1c between 7.5% and 11.0%.
- People whose blood sugar has not been adequately controlled despite being on a stable diabetes medication regimen for at least 3 months before screening — specifically those taking: metformin alone; or metformin combined with a sulfonylurea; or metformin combined with an SGLT2 inhibitor — each at the required doses (confirm specific dose requirements with the trial site).
- People with a Body Mass Index (BMI) of 23.0 or above, whose body weight has been stable (changing less than 5%) for the 3 months before screening, based on self-report.
- People who have no plans for pregnancy from the time of screening until 6 months after the study ends, who are willing to use contraception, and who have no plans to donate sperm or eggs within 6 months of completing the study (this applies to participants and their partners).
- People who have been fully informed about the study and have voluntarily signed a written consent form.
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 with a known allergy or sensitivity to the study drug, its ingredients, or similar medications.
- People who have taken any of the following types of medication in the 3 months before screening: other diabetes medications beyond those listed in the background therapy (short-term insulin use of 14 days or less for an acute condition such as surgery or hospitalisation is allowed); medications that can affect blood sugar levels, such as steroid tablets or growth hormone (unless used for fewer than 7 days and stopped well before screening); or weight-loss medications, including orlistat, semaglutide, or similar prescription or over-the-counter products.
- People with a diagnosis of any other type of diabetes, such as Type 1 diabetes or certain rare forms of diabetes caused by genetic conditions or pancreatic disease.
- People with a history of acute or long-term pancreatitis (inflammation of the pancreas), or who have had surgery on the pancreas.
- People with a history of symptomatic gallbladder disease within the past year (those who had their gallbladder removed at least 3 months before screening and have had no lasting complications may not be excluded — confirm with trial site); or people whose ultrasound at screening shows large gallbladder stones (2 cm or larger), gallbladder polyps (1 cm or larger), or other gallbladder findings the doctor considers a safety concern.
- People with a personal or family history (parents, children, or siblings) of a type of thyroid cancer called medullary thyroid carcinoma (MTC), or a condition called multiple endocrine neoplasia type 2 (MEN2).
- People with a history of certain blood disorders that may affect the reliability of the HbA1c test or increase health risks, such as aplastic anaemia, myelodysplastic syndrome, sickle cell disease, or thalassaemia.
- People with a history of moderate to severe depression, or a history of serious psychiatric conditions such as suicidal thoughts or attempts, schizophrenia, or bipolar disorder.
- People who have had a significant heart or stroke-related event in the 6 months before screening, including: a heart attack or unstable chest pain (angina); heart-related surgery such as bypass or stenting; severe heart failure (NYHA Class III–IV); a stroke or mini-stroke (excluding certain old, minor stroke findings); or other heart or vascular conditions the doctor considers unsuitable for study participation.
- People found at screening to have severe eye problems affecting the retina or macula (such as proliferative retinopathy, macular oedema, or retinal detachment) that the doctor determines need urgent treatment.
- People who have had a severe hypoglycaemic episode (very low blood sugar causing serious confusion and needing help from another person to recover) or repeated episodes of low blood sugar (2 or more times) within 6 months before screening.
- People who have had a serious diabetes-related complication in the 6 months before screening, such as diabetic ketoacidosis, a hyperosmolar hyperglycaemic state requiring hospitalisation, or diabetic foot.
- People who currently have a condition affecting how the stomach or intestines move or empty (such as gastroparesis or bowel obstruction), gastrointestinal diseases the doctor considers a safety risk, or a history of major gastrointestinal surgery (minor procedures such as appendectomy or polyp removal that have fully healed may not be excluded — confirm with trial site).
- People who have had major surgery, serious injury, or severe infection within 1 month before screening that the doctor considers makes study participation unsuitable.
- People with a history of cancer, with some exceptions for certain treated and stable cancers such as cervical carcinoma in situ, basal or squamous cell skin cancer, localised prostate cancer after surgery, or ductal carcinoma in situ of the breast after surgery — the doctor must assess these as currently stable (confirm with trial site).
- People with other ongoing medical conditions affecting the lungs, kidneys, nervous system, blood, or immune system that the doctor considers may affect safety, the study's results, or the person's ability to follow the study requirements.
- People whose screening blood tests show liver or kidney problems, specifically: liver enzymes (ALT and/or AST) at 3 times or more above the normal upper limit; bilirubin at 1.5 times or more above the normal upper limit; or a kidney filtration rate (eGFR) below 45 mL/min/1.73m².
- People with a blood calcitonin level of 50 pg/mL or higher at screening (calcitonin is a marker sometimes associated with thyroid concerns).
- People with thyroid problems that are not well controlled on a stable medication dose, or who have thyroid test results at screening that the doctor considers need new treatment, or who have thyroid nodules on ultrasound rated at a level suggesting possible biopsy or surgery may be needed during the study (confirm classification details with trial site).
- People with fasting triglyceride (a type of blood fat) levels of 5.6 mmol/L or higher at screening.
- People with pancreatic enzyme levels (amylase and/or lipase) more than twice the normal upper limit at screening.
- People with an abnormal blood clotting result (INR above the normal upper limit) at screening.
- People with a haemoglobin (a measure of red blood cells) level below 100 g/L at screening.
- People with high blood pressure that is untreated or poorly controlled, defined as a systolic reading of 160 mmHg or higher and/or a diastolic reading of 100 mmHg or higher, based on the average of three measurements during the screening period.
- People with clinically significant heart rhythm abnormalities on an ECG (heart tracing) at screening, including: second- or third-degree heart block; long QT syndrome or a prolonged QT interval (above 470 ms for females or above 450 ms for males); Wolff-Parkinson-White syndrome; a resting heart rate below 50 or above 100 beats per minute; or other serious heart rhythm problems requiring treatment.
- People who test positive for hepatitis B with a detectable viral load, or positive for hepatitis C with a detectable viral load, or positive for HIV, or positive for syphilis.
- People with any other abnormal results from physical examination, vital signs, or laboratory tests that the doctor considers pose a significant risk or would interfere with the study's assessments.
- People who have participated in another interventional clinical trial within 3 months before screening (this does not apply to people who were only screened but not enrolled, or enrolled but did not receive any treatment).
- People who have had a blood loss of 400 mL or more (from injury, blood draws, or donation), or who have received a blood or blood product transfusion, within the 3 months before screening.
- Women who are currently pregnant or breastfeeding.
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.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Kids Helpline — 24/7, free and private for anyone aged 5 to 25: 1800 55 1800
- headspace — mental health support for 12 to 25 year olds: headspace.org.au
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Phone: +86 18998165570
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 3
Sponsor
The United Bio-Technology (Hengqin) Co., Ltd.
Registry
ClinicalTrials.gov
Start date
30 July 2026
Est. completion
29 February 2028
Primary endpoints
HbA1c
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 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.