Printed from Voxsanity (voxsanity.com.au) — NCT07697391 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 4 Type 2 Diabetes Trial, Not Yet Recruiting
NCT07697391
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 65 years (male or female).
- People with a recent type 2 diabetes diagnosis — meaning diagnosed within the last 3 years and not having taken any blood sugar-lowering medications in the past 3 months — with blood sugar levels confirmed by specific test results at the time of diagnosis.
- People with a body mass index (a measure of body weight relative to height) of 28 or above but below 40.
- People who are willing to use reliable birth control and have no plans to become pregnant in the 12 months after joining the trial; female participants must have a negative pregnancy test at the screening visit.
- People who are able to communicate with the research team, are willing to follow the study rules, and agree to sign a 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 who have type 1 diabetes, type 2 diabetes that requires insulin treatment, or any other specific form of diabetes.
- People whose body weight has changed by more than 5% in the 12 weeks before the screening visit.
- People who are pregnant or currently breastfeeding.
- People who have experienced a serious injury, severe infection, or surgery within the month before the screening visit that could affect blood sugar levels.
- People who have had a serious heart or stroke-related event in the 6 months before screening, such as a heart attack, angina (chest pain from reduced blood flow to the heart), irregular heartbeat, stroke, or brain bleed.
- People with a history of acute or chronic inflammation of the pancreas (pancreatitis), pancreatic injury, or abnormally high levels of a pancreatic enzyme (amylase) on their screening blood test.
- People with a current or past cancer diagnosis, except for certain very limited types (a specific type of skin cancer, or early-stage cervical or prostate cancer that has not spread); or any cancer diagnosis in the 5 years before screening.
- People with a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related inherited condition (multiple endocrine neoplasia type 2), or a history of thyroid nodules (growths on the thyroid gland).
- People with blood disorders that cause the breakdown of red blood cells or affect the stability of red blood cells, which could interfere with a key diabetes blood test (HbA1c).
- People who have had an organ transplant or who have a condition — whether present from birth or developed over time — that affects how the immune system works.
- People with schizophrenia or another psychiatric condition that may make it difficult to take part in the study.
- People with an unstable or actively treated hormonal condition that affects blood sugar, such as an overactive thyroid, abnormal growth hormone levels, or a condition causing excess cortisol (confirm with trial site).
- People with high blood pressure that remains above a certain level (systolic above 150 mmHg and/or diastolic above 90 mmHg) even while on stable blood pressure medication.
- People with significant problems affecting how the stomach empties, serious long-term gut conditions, diabetic stomach paralysis (gastroparesis), long-term use of medications that affect gut movement, or a history of stomach or bowel surgery.
- People with special dietary needs or allergies to foods such as soy products or dairy products.
- People who have used certain medications that affect blood sugar regulation in the 3 months before joining the trial, such as steroid medications, growth hormone, thyroid hormone, sex hormones, cyclosporine, or phenytoin.
- People with a history of allergic reactions to two or more different categories of substances.
- People whose fasting C-peptide level (a marker of insulin production) is below a certain threshold on blood testing.
- People whose calcitonin level (a hormone linked to thyroid function) is above a certain threshold on blood testing.
- People with certain abnormal blood test results, including elevated liver enzymes, high bilirubin, very high triglyceride (blood fat) levels, reduced kidney function, or significant anaemia.
- People who have had a serious eye complication related to diabetes requiring urgent treatment in the year before joining, or a history of diabetic ketoacidosis, a dangerous high blood sugar crisis, or a severe metabolic disturbance causing neurological or psychiatric symptoms.
- People with a history of, or risk factors for, epilepsy, fainting, cardiac arrest, irregular heartbeat, heart conduction problems, structural heart disease, or abnormal levels of certain minerals in the blood (such as potassium, magnesium, or calcium).
- People with an active bacterial, viral, or fungal infection that requires hospital admission or intravenous antibiotics.
- People who test positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis antibody.
- People who test positive for illicit drugs or who have a history of drug dependence.
- People who have taken part in another clinical trial in the 3 months before enrolling, or who are currently taking part in another drug or device trial.
- People who, in the opinion of the investigator, have any other condition that makes them unsuitable for this study.
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.
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.
Contact this trial
Phone: +8619966188536
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 4
Sponsor
The First Affiliated Hospital of Anhui Medical University
Registry
ClinicalTrials.gov
Start date
20 July 2026
Est. completion
31 October 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Percent Change in Body Weight From Baseline to Week 52
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 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.