Printed from Voxsanity (voxsanity.com.au) — NCT07575438 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Type 2 Diabetes Trial, Not Yet Recruiting
NCT07575438
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
- Men, or women who have gone through menopause (confirmed by a blood test showing FSH at or above 30 U/l), are the population this trial is looking for.
- People with a body mass index (BMI) between 25 and 40, which is a measure of body weight relative to height.
- People who do not currently smoke tobacco, or who stopped smoking more than one year ago.
- People who drink fewer than 7 alcoholic drinks per week.
- People with a specific blood protein level (plasma apoB) at or above 1.05 g/L, measured by a blood test.
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 high calculated risk of heart disease, specifically a Framingham Risk Score of 20% or more (confirm with trial site).
- People with a past history of heart or blood vessel events, such as stroke, mini-stroke, heart attack, angina, heart failure, or irregular heartbeat.
- People with high blood pressure readings above 140 mmHg (top number) or 90 mmHg (bottom number).
- People who have diabetes, or whose blood sugar control test (HbA1c) result is 6.5% or higher.
- People who experience episodes of low blood sugar after eating (reactive hypoglycaemia).
- People who have had a cancer diagnosis within the last 3 years, or who have had lymph nodes removed.
- People with a thyroid condition that is untreated or whose thyroid medication dose is not yet stable.
- People with severely reduced kidney function (eGFR below 30 mL/min/1.73 m²), confirmed by a blood test.
- People with liver problems, shown by liver enzyme levels (AST/ALT) more than three times the normal range.
- People with low red blood cell levels (anaemia), specifically haemoglobin below 120 g/L in women or below 130 g/L in men.
- People with a condition that causes problems with blood clotting or bleeding.
- People with a tendency to bleed more easily than normal.
- People who have a condition or have had a surgery that affects how the body absorbs nutrients, such as bariatric (weight loss) surgery.
- People with an autoimmune or long-term inflammatory condition, such as coeliac disease, inflammatory bowel disease, Graves' disease, multiple sclerosis, psoriasis, rheumatoid arthritis, or lupus.
- People who experience ongoing or frequent diarrhoea.
- People who have had their gallbladder removed.
- People who have sleep apnoea (a condition where breathing repeatedly stops during sleep).
- People who have a history of seizures.
- People with a known history of difficulty having blood taken from a vein.
- People with a known history of fainting or losing consciousness during blood draws.
- People currently taking certain medications, including steroids taken throughout the body, blood pressure medications, anti-psychotic or weight-promoting psychiatric medications, blood thinners or anti-clotting drugs (such as aspirin, NSAIDs, warfarin, or coumadin), adrenaline-like medications, weight-loss drugs (such as GLP-1 agonists), or cholesterol-lowering medications (such as statins or anti-PCSK9 treatments).
- People with an allergy to seafood, fish, or corn oil.
- People with an allergy to bovine (cow-derived) gelatine or glycerine, which are components of the softgel capsules used in this trial.
- People with an allergy to Xylocaine, a local anaesthetic used during a fat tissue sample procedure.
- People who have surgery or a blood transfusion planned during the study period.
- People with a known history of substance abuse.
- People who do more than 5 hours of aerobic exercise per week.
- People who are already taking more than 1 gram per day of EPA and/or DHA omega-3 supplements.
- People who are unable to follow the study requirements, such as arriving to appointments in a fasted state.
- People who have cancelled the same scheduled study visit more than once.
- People who do not have enough time to take part in the full study, which runs for 18 to 22 weeks.
- People who the study doctor considers unsuitable for other reasons, including difficulty communicating in French or English.
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: May Faraj, P.Dt., Ph.D., Institut de recherches cliniques de Montréal (IRCM)/ Université de Montréal
Phone: 514-987-5500
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 2
Sponsor
May Faraj, PDt, PhD
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
1 December 2029
Where this trial is recruiting
🇨🇦 Canada
Primary endpoints
Change from baseline to 12 weeks in the disposition index
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 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.