Printed from Voxsanity (voxsanity.com.au) — NCT06558422 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Type 2 Diabetes Trial, Not Yet Recruiting
NCT06558422
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 between 18 and 65 years old, of any gender.
- People with a body mass index (a measure of body weight relative to height) between 27 and 50.
- People who are able to understand written and spoken English and/or Spanish.
- People with signs that their body is not responding well to insulin, shown by any of the following: a prediabetes blood test result (HbA1c of 5.7–6.4%) or a mildly elevated fasting blood sugar (100–125 mg/dL after not eating for 8 hours) within the past year and at screening; a specific insulin resistance score (HOMA-IR) of 2.73 or higher; or a fasting insulin level of 13 µU/mL or higher on screening blood tests.
- People with a mild-to-moderate form of fatty liver disease (called MASLD) confirmed by a special painless liver scan (VCTE), showing a fat level of S1–S3 and a scarring (fibrosis) level of F0–F2.
- People who have given written consent to take part in the trial (available in English or Spanish) before any study procedures begin.
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 are not able to provide informed consent in English or Spanish.
- People who are unwilling to use a bedpan or urinal for urination, or unwilling to avoid non-emergency mobile device use during a specific study procedure (the clamp).
- People who have lost 5% or more of their body weight in the 3 months before screening.
- People with blood pressure outside the acceptable range — this includes a top number below 90 or above 160, or a bottom number below 60 or above 100 (even if being treated for blood pressure).
- People with a resting heart rate below 60 or 110 beats per minute or higher (although certain heart rate conditions considered harmless by the person's own doctor may be allowed at the lead researcher's discretion).
- People with an abnormal heart tracing (ECG/electrocardiogram) at screening, or one on file from within the past 90 days.
- People whose blood tests show diabetes — an HbA1c of 6.5% or higher, and/or a fasting blood sugar of 126 mg/dL or higher.
- Women who could become pregnant and have a positive pregnancy test at screening.
- People with a positive drug screen, except for legally prescribed medications and/or marijuana (see further details below).
- People with notable liver enzyme abnormalities — liver enzymes (AST or ALT) more than 3 times the upper limit of normal, or a bilirubin level more than 1.25 times the upper limit of normal.
- People with fasting triglyceride (a type of blood fat) levels of 400 mg/dL or higher at screening.
- People with blood electrolyte (salt/mineral) levels that the lead researcher considers potentially significant.
- People with certain abnormal blood count results — haemoglobin below 10 g/dL or haematocrit below 30%, or a platelet count below 100,000/µL.
- Women who are currently pregnant (confirmed by blood or urine test) or who are trying to become pregnant.
- Women who are currently breastfeeding.
- People who have ever been diagnosed with diabetes, including based on any of these: an HbA1c of 6.5% or higher (or rapidly rising values causing clinical concern); a fasting blood sugar of 126 mg/dL or higher; a blood sugar of 200 mg/dL or higher two hours after a glucose drink; a random blood sugar of 200 mg/dL or higher along with typical symptoms of high blood sugar, diabetic ketoacidosis, or a related serious condition.
- People with a history of diabetes during pregnancy (gestational diabetes) within the past 5 years.
- People who have used most blood-sugar-lowering medications within the 30 days before screening — this includes thiazolidinediones, sulfonylureas, meglitinides, DPP4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, amylin mimetics, acarbose, and insulin. (Note: Metformin is allowed if all inclusion criteria are still met at screening.)
- People where there is clinical concern that the body produces little or no insulin on its own (for example, those with type 1 diabetes or pancreatic disease).
- People with a known diagnosis of familial combined hyperlipidemia or familial chylomicronemia syndrome (inherited conditions affecting blood fats).
- People who have used certain cholesterol/fat-lowering medications within 30 days before screening — including fibrates (such as fenofibrate, clofibrate, or gemfibrozil) or prescription-strength omega-3 fatty acid medications (such as Lovaza® or Vascepa®).
- People with a known, documented history of any of the following conditions: pancreatic problems; cardiovascular (heart or blood vessel) disease (note: uncomplicated high blood pressure alone does not exclude someone); chronic kidney disease at stage 3 or worse; advanced or severe liver disease, including a fibrosis score of F3–F4 on the screening liver scan; gallstone disease; a long-term viral illness; active conditions that affect the body's ability to absorb nutrients; an active seizure disorder (including those managed with anti-seizure medications); psychiatric conditions causing significant difficulty with daily functioning and/or requiring certain medications associated with weight gain or metabolic problems (such as clozapine or olanzapine), or requiring monoamine oxidase inhibitors, tricyclic antidepressants, or lithium; known adrenal gland disease; a history of blood clots in the veins (deep vein thrombosis or pulmonary embolism) or any need for blood-thinning treatment; bleeding disorders (including those caused by blood thinners) or significant anaemia; active cancer, or a hormone-producing non-cancerous growth.
- People where the treating doctor has clinical concern about a higher risk of fluid overload, including due to medications or heart, liver, or kidney problems as listed above.
- People where the treating doctor has clinical concern about a higher risk of low potassium, including a low potassium level on screening blood tests, use of certain medications, or any of the medical conditions listed above.
- People currently using, or who have used within 30 days before screening, certain medications — including those prescribed for any of the excluded conditions above (with some exceptions where a drug is used for a different, permitted reason, such as anti-seizure drugs used for non-seizure conditions, or ACE inhibitors/ARBs used for uncomplicated high blood pressure rather than heart failure); loop diuretics (such as furosemide, torsemide, or ethacrynic acid); oral or injected corticosteroids at doses higher than 5 mg prednisone per day (or equivalent) for more than 3 days in the past 30 days (topical and inhaled forms are permitted); fludrocortisone; beta blockers; or certain calcium channel blockers (verapamil or diltiazem).
- People with a history of certain weight-loss (bariatric) surgeries, including Roux-en-Y gastric bypass, biliopancreatic diversion, or restrictive procedures (such as lap band or sleeve gastrectomy) performed within the past 6 months.
- People where there is clinical concern about excess alcohol use, including a documented history during screening or a reported regular intake of more than 2 drinks per day for males or more than 1 drink per day for females.
- People with a positive drug screen, unless for legally prescribed medications or marijuana/THC — marijuana is allowed only if the person agrees not to use it during the same period they are asked to avoid alcohol.
- People who have had a severe infection or an illness with fever within 14 days before screening.
- People with any other disease, condition, or blood test result that, in the lead researcher's judgement, would pose an unacceptable risk or interfere with the study results.
- People with a known allergy or sensitivity to any ingredient in the study medications, certain foods (including soy, dairy, peanuts, tree nuts, or egg), IV drip equipment, plastics, adhesive or silicone materials, a history of reactions at IV sites with other medicines, or any ongoing significant allergy or sensitivity as judged by the lead researcher.
- People currently enrolled in another clinical trial of an experimental drug, or who have been enrolled in one within 30 days before screening or within 5 half-lives of the experimental drug used, whichever period is longer.
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: Joshua R Cook, MD, PhD, Columbia University
Phone: 2123056289
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 1
Sponsor
Registry
ClinicalTrials.gov
Start date
1 January 2027
Est. completion
31 December 2028
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Hepatic de novo lipogenesis (DNL) (absolute value); Hepatic de novo lipogenesis (DNL) (relative value); Endogenous glucose production (EGP) (absolute value); Endogenous glucose production (EGP) (relative value); Plasma glucose level; Serum insulin level
Can't join this trial?
Data last synced from ClinicalTrials.gov: 18 August 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.