Printed from Voxsanity (voxsanity.com.au) — NCT07308184 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Type 2 Diabetes
Phase 3 Type 2 Diabetes Trial, Not Yet Recruiting
NCT07308184
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 19 to 75 years old at the time of signing the consent form.
- People with a body mass index (BMI) between 20 and 35 at the screening visit (BMI is calculated by dividing weight in kilograms by height in metres squared).
- People who were diagnosed with type 2 diabetes at least 12 weeks before the screening visit and have been following a stable diet and exercise program for at least 8 weeks before the screening visit.
- People who have not taken any blood sugar-lowering medications in the 12 weeks before the screening visit, OR people who took blood sugar-lowering tablets within the past 12 weeks but stopped taking them at least 5 weeks before the screening visit.
- People whose HbA1c blood test result (a measure of average blood sugar over several months) is between 7.5% and 11.0% at the screening visit, and between 7.0% and 10.5% before being assigned to a treatment group.
- People whose fasting blood sugar level is 250 mg/dL (13.9 mmol/L) or lower at both the screening visit and the pre-treatment testing.
- People who are able to check their own blood sugar levels at home and keep a diary record during the study.
- People who agree to use medically acceptable methods of contraception during the study, including people who are medically unable to become pregnant.
- People who are able to understand and follow instructions and take part in the full study.
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 been diagnosed with type 1 diabetes, or diabetes caused by a genetic condition or a problem with the pancreas.
- People who have taken certain diabetes medications called GLP-1 analogues or DPP-4 inhibitors within 12 weeks before the screening visit.
- People who have used insulin within 24 weeks before the screening visit (except for short-term use of 14 days or fewer to treat high blood sugar symptoms).
- People who have had diabetic ketoacidosis, hyperosmolar hyperglycemia, or diabetic lactic acidosis (serious diabetes-related emergencies) within 24 weeks before the screening visit.
- People with a history of serious long-term diabetes complications — such as advanced eye disease affecting the retina or central vision, or severe nerve damage in the feet or legs — within 24 weeks before the screening visit.
- People who have had a severe hypoglycemic episode (very low blood sugar requiring help from another person) within the past 24 weeks, or two or more episodes of moderately low blood sugar (below 54 mg/dL) within the 4 weeks before the screening visit.
- People who have had a serious injury, infection, or surgery that could affect blood sugar control within 4 weeks before the screening visit.
- People with uncontrolled overactive or underactive thyroid, unless their thyroid levels fall within an acceptable range, they have been on a stable thyroid medication dose for at least 12 weeks, and their dose is not expected to change during the study.
- People who have a personal or family history of a specific type of thyroid cancer called medullary thyroid carcinoma (MTC), or a condition called multiple endocrine neoplasia type 2 (MEN2).
- People who have used weight-loss medications, products, or programs within 12 weeks before the screening visit, or whose body weight has changed by more than 5% (confirm with trial site).
- People who have had any of the following heart or blood vessel conditions within 24 weeks before the screening visit: severe heart failure (NYHA class III or IV), coronary artery bypass surgery or a stent procedure, a heart attack or unstable chest pain, or a serious stroke or mini-stroke (TIA).
- People with a history of uncontrolled lung disease — such as severe chronic obstructive pulmonary disease (COPD), asthma, or active tuberculosis — within 24 weeks before the screening visit.
- People who have had serious stomach or bowel disease (such as an active ulcer), stomach or bowel surgery, a significant problem with how the stomach empties, or who have regularly used medications that affect gut movement within 24 weeks before the screening visit. (Note: people who have had their appendix or gallbladder removed may still be eligible.)
- People with a history of acute or chronic inflammation of the pancreas (pancreatitis), gallbladder inflammation, or injury to the pancreas.
- People with a history of a malignant (cancerous) tumour within the past 5 years, except for people who have been confirmed to be in complete remission for 5 or more years with no recurrence, or people with a history of certain cancers — such as non-medullary thyroid cancer, cervical carcinoma in situ, or basal cell or squamous cell skin cancer.
- People with unstable major depression, anxiety disorder, or other serious mental health conditions such as schizophrenia or bipolar disorder.
- People who tested positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody at the screening visit. (Note: people who test positive for hepatitis C antibody but negative for hepatitis C virus RNA may still be eligible.)
- People whose test results at the screening visit or pre-treatment testing show any of the following: severely high blood pressure (systolic ≥160 mmHg or diastolic ≥100 mmHg); significantly elevated liver enzymes or bilirubin; elevated pancreas enzymes (amylase or lipase); reduced kidney function (eGFR ≤45); very high triglyceride (blood fat) levels; low C-peptide levels (a marker of insulin production); low haemoglobin (anaemia); or high calcitonin levels (a marker that may relate to thyroid concerns).
- People with blood conditions — such as certain types of anaemia — that could interfere with the accuracy of the HbA1c blood test.
- People with a history of alcohol dependency or substance misuse.
- People who have taken systemic steroids or growth hormones for 7 or more days within 8 weeks before the screening visit (including tablets or intravenous forms).
- People who have previously had a known resistance or allergic reaction to medications in the same class as the drug being studied.
- People who have taken part in another clinical trial or used an experimental medical device within 12 weeks before the screening visit.
- People who have donated blood, had significant blood loss (more than 400 mL), or received a blood transfusion or blood products within 12 weeks before the screening visit.
- People with a history of a specific eye condition called nonarteritic anterior ischemic optic neuropathy (NAION), which can cause sudden vision loss.
- People who are pregnant, have a positive pregnancy test, or are currently breastfeeding.
- People whom the trial investigator considers unsuitable to participate for any other reason.
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.
Contact this trial
Principal Investigator: Sung-Rae Kim, Bucheon St. Mary Hospital, The Catholic University of Korea
Phone: 031-5176-4663
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
HK inno.N Corporation
Registry
ClinicalTrials.gov
Start date
1 December 2025
Est. completion
1 August 2027
Primary endpoints
A change in HbA1c from baseline at Week 24
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 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.