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Phase 3 Type 2 Diabetes Trial, Not Yet Recruiting
NCT06731075
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 50 years or older, of any gender.
- People who have been diagnosed with type 2 diabetes for at least 6 months before the screening visit, with a blood sugar control measure (HbA1c) between 7.2% and 10.0% at screening.
- People who have been taking a stable dose of one to three approved blood sugar-lowering medications (such as metformin, a sulfonylurea, a DPP-4 inhibitor, an SGLT-2 inhibitor, a thiazolidinedione, an insulin secretagogue, an oral or injected GLP-1 receptor agonist, a glucosidase inhibitor, or pramlintide) for at least 3 months before screening — injected insulin is not included in this list.
- People with a body mass index (BMI) of 28 or below at screening, with a stable weight (no more than 5 kg gained or lost in the 3 months before screening).
- People whose kidneys are functioning at an adequate level, measured by an eGFR of 30 ml/min or above.
- Women who could potentially become pregnant must have a negative pregnancy blood test at screening.
- Women who could potentially become pregnant must agree to avoid becoming pregnant from at least 30 days before the study treatment starts, throughout the entire study, and for 30 days after the last dose.
- Women who could potentially become pregnant must agree to use an accepted form of contraception during that same period — this means hormonal contraception (pill or injection) plus an additional barrier method (such as a diaphragm, condom, sponge, or spermicide).
- If hormonal contraception is not used, women must use two barrier methods together, chosen from: diaphragm, condom, copper intrauterine device, sponge, or spermicide, for the same period described above.
- Complete abstinence from heterosexual activity may be accepted as contraception if it is the person's consistent and usual lifestyle, and if accepted by the relevant local regulatory and ethics bodies (periodic abstinence methods and withdrawal are not accepted).
- Women who are not able to become pregnant are also eligible — this includes women aged 45 or older who have had no menstrual period for at least 12 months, women who have had a hysterectomy and/or removal or blocking of the ovaries or fallopian tubes at least 6 weeks before screening, or women with a medical condition that prevents pregnancy.
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 diagnosis of type 1 diabetes.
- People whose diabetes is caused by another condition, such as a genetic syndrome, pancreatic disease, a hormonal disorder, a medication or chemical, or an organ transplant.
- People who have used injected insulin within 3 months before the first visit.
- People who have had more than 2 episodes of severe low blood sugar in the 6 months before screening.
- People who have a history of not being able to feel the warning signs of low blood sugar (hypoglycemic unawareness).
- People with a history of unstable chest pain, heart attack, moderate-to-severe heart failure, heart valve disease, a heart rhythm problem requiring treatment, high blood pressure in the lungs, heart surgery, coronary artery procedure, stroke, or a mini-stroke (TIA) within 6 months before screening.
- People with uncontrolled or untreated severe high blood pressure, defined as a top reading of 160 mmHg or above and/or a bottom reading of 100 mmHg or above (one repeat measurement is allowed).
- People with poor kidney function, defined as an eGFR below 30 mL/min.
- People with a history of, or currently having, advanced eye disease related to diabetes (proliferative retinopathy) that requires treatment.
- People with a psychiatric condition that, in the trial doctor's judgment, could affect their safety or their ability to participate properly in the study.
- People with certain abnormal blood test results at screening, including: thyroid hormone levels that are too low or more than 1.5 times the upper normal limit; liver enzyme levels more than 3 times the upper normal limit; fasting triglyceride (blood fat) levels above 600 mg/dL; or any other significant abnormality that could affect the study results or safety assessments (one repeat test is allowed for each of these).
- People with a known active liver disease (other than fatty liver), primary biliary cirrhosis, or active symptomatic gallbladder disease.
- People who test positive for HIV, hepatitis B, or hepatitis C.
- People who have had, or currently have, a cancer diagnosis within the past 5 years — except for certain treated, non-invasive skin cancers or cervical carcinoma in situ that have been adequately managed.
- People who have used injectable insulin for more than 7 days at any point in the 6 months before screening.
- People who have used thyroid hormone medications (unless on a stable ongoing replacement dose) within 6 weeks before screening.
- People who have used oral, intravenous, or intramuscular steroids within one month before enrolment (steroid injections into joints or topical steroid creams are not considered a problem).
- People currently using medications known to affect blood sugar levels or to reduce the body's ability to recover from low blood sugar, such as immunosuppressive or immunomodulating drugs taken by mouth or injection (inhaled nasal steroids are permitted).
- People with a known allergy to soy.
- People currently in an active (non-maintenance) weight loss program, or who have started a weight loss medication (such as orlistat or liraglutide) within 3 months before screening.
- People who have previously had bariatric (weight loss) surgery.
- People who are pregnant or breastfeeding.
- People who use recreational or illegal drugs, or who have had a history of drug or alcohol misuse or dependence within 1 year before screening — alcohol misuse is defined as more than 3 drinks per day, more than 14 drinks per week, or binge drinking (occasional use of cannabis products is allowed provided none has been used in the week before each visit).
- People using any weight loss products, whether prescription, over-the-counter, or otherwise — except for GLP-1 medications being used specifically to treat their diabetes.
- People who have any other condition or factor that the trial investigator considers makes them unsuitable for the study (confirm with trial site).
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: Miriam Kidron, Ph.D., Oramed, Ltd.
Phone: 972-2-566-0001
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
Oramed, Ltd.
Registry
ClinicalTrials.gov
Start date
15 December 2025
Est. completion
25 April 2027
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Change from baseline in A1C at 26 weeks
Can't join this trial?
Data last synced from ClinicalTrials.gov: 24 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.