Printed from Voxsanity (voxsanity.com.au) — NCT07628985 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Type 2 Diabetes Trial, Not Yet Recruiting
NCT07628985
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 years and older who are willing to take part and sign a consent form agreeing to participate.
- People of any sex, whether male or female.
- People who have been diagnosed with type 2 diabetes for more than 6 months, based on recognised international diagnostic standards.
- People who have been taking metformin on its own (no other diabetes medicines) at a stable dose for at least 90 days before screening — at a dose of at least 1500 mg per day, or the highest dose they can tolerate (at least 1000 mg per day) — with no planned changes to that dose during the study.
- People whose HbA1c (a blood test measuring average blood sugar levels over time) is between 7.0% and 10.5%, as measured by the trial's central laboratory during screening.
- People whose fasting blood sugar level is below 270 mg/dL at screening.
- People with a Body Mass Index (BMI) of 27 kg/m² or higher.
- People whose body weight has been stable in the 3 months before screening, meaning it has changed by no more than 5%.
- Women who could become pregnant must have a negative pregnancy test at screening and at the start of the study, must not be breastfeeding, must have no plans to become pregnant from signing the consent form until 6 months after the last dose of study treatment, and must agree to use effective contraception during that period.
- Men must have no plans to donate sperm during the same period described above.
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 known or suspected allergy or sensitivity to GLP-1 type diabetes medicines, or who have a medical reason that rules out using this type of medication.
- People who have taken part in another clinical trial and received treatment within the 3 months before screening.
- People who have experienced major surgery or surgical procedures in the 3 months before screening that may have significantly affected body weight, eating, digestion, stomach emptying, movement, or recovery.
- People who are currently taking non-diabetes medicines that affect body weight.
- People who are participating in a weight loss program that is not in the maintenance (ongoing stability) phase.
- People who have started, stopped, or significantly changed medications within the 12 weeks before screening — or who plan to do so during the study — where the investigator believes those medications may significantly affect blood sugar or body weight (for example, long-term steroid medicines, antipsychotics, anti-epilepsy medicines, or other medicines with significant effects on metabolism).
- People with a history of alcohol or drug misuse (including substances such as amphetamines, benzodiazepines, marijuana, cocaine, methadone, or morphine-like drugs) within the 6 months before screening, based on medical history or a positive drug screening test.
- People who have used insulin for more than 14 days in a row within the year before screening (insulin used for diabetes during pregnancy does not count under this criterion).
- People who have taken GLP-1 receptor agonist medicines (a type of diabetes treatment) within the 6 months before screening.
- People who have taken DPP-4 inhibitor medicines (another type of diabetes treatment) within the 3 months before screening.
- People who have used growth hormone or other medicines that the investigator believes may affect insulin levels, within the 3 months before screening.
- People who have had diabetic ketoacidosis, diabetic lactic acidosis, or a hyperosmolar non-ketotic coma within the 6 months before screening.
- People who have had certain serious diabetes-related complications within the 6 months before screening, including unstable or treated eye disease affecting the retina or macula, severe nerve damage, poor circulation in the legs, or diabetic foot.
- People who have had a severe hypoglycaemic episode (very low blood sugar requiring help from another person) in the 6 months before screening; or 3 or more episodes of low blood sugar (blood glucose at or below 70 mg/dL) in the month before screening; or who regularly experience symptoms related to low blood sugar.
- People who have experienced severe injury, serious infection, or major surgery in the month before screening that the investigator believes may affect blood sugar control.
- People with a blood calcitonin level (a hormone measured by a blood test) of 50 pg/mL or higher at screening.
- People with a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a condition called multiple endocrine neoplasia type 2A or 2B; or people who have been diagnosed with any other cancer in the past 5 years.
- People with an uncontrolled overactive or underactive thyroid — though people who have been on stable thyroid replacement medicine for 3 or more months before screening, and whose thyroid levels are within normal ranges, may not be excluded (confirm with trial site).
- People with a history of acute or chronic hepatitis, acute or chronic pancreatitis, symptomatic gallbladder disease (such as multiple gallstones), pancreatic injury, or other conditions that may increase the risk of developing pancreatitis.
- People with uncontrolled high blood pressure, defined as a top number (systolic) of 160 mmHg or more and/or a bottom number (diastolic) of 100 mmHg or more at screening.
- People who have been hospitalised for a serious heart or blood vessel event (such as heart attack, unstable chest pain, stroke, or peripheral vascular disease) in the 6 months before screening; people with a cardiac pacemaker, certain heart rhythm problems, long QT syndrome, or a specific heart electrical reading (QTc of 450 ms or more) without a pacemaker; people with severe heart failure (NYHA class III or IV); or people with any other significant heart condition that the investigator considers makes participation unsuitable.
- People with significant blood disorders or any condition that may affect red blood cells and interfere with HbA1c test results — including conditions such as aplastic anaemia, thalassemia, sickle cell anaemia, or haemolytic anaemia — as well as people who have donated blood, lost more than 400 mL of blood, or received a blood transfusion in the 3 months before screening.
- People with significant problems affecting how the stomach empties (such as a gastric outlet obstruction), severe long-term digestive conditions (such as active stomach ulcers in the past 6 months), prolonged use of certain medicines that affect gut movement, or gastrointestinal surgery within the 6 months before screening, where the investigator considers these factors make participation unsuitable.
- People with significantly abnormal blood test results at screening, including: liver enzyme levels (ALT or AST) more than 2.5 times the upper limit of normal; fasting triglycerides above 500 mg/dL; amylase and/or lipase levels 1.5 times or more above the upper limit of normal; fasting blood glucose above 270 mg/dL; or estimated kidney filtration rate below 45 mL/min/1.73 m².
- People with an active Hepatitis B infection confirmed by specific blood markers and detectable virus in the blood.
- People with an active Hepatitis C infection confirmed by positive antibodies and detectable virus in the blood (people with a past infection that has fully resolved may not be excluded — confirm with trial site).
- People with an HIV infection that has clinical impact or is on an unstable treatment plan that the investigator believes may affect safety or study participation.
- People with an active syphilis infection (caused by Treponema pallidum) confirmed by specific tests.
- People with a history of organ transplantation, or who have an acquired or inherited immune system disorder.
- People with a history of psychiatric conditions such as schizophrenia, bipolar disorder, or previous suicidal behaviour; or people taking psychiatric medications that the investigator believes may interfere with participation or adherence to the study.
- People with any other medical condition or circumstance that the investigator believes may affect safety, the ability to follow the study protocol, or the reliability of the study results.
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.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Principal Investigator: Sergio César Hernández Jiménez, Dr., Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Centro de Atención Integral del Paciente con Diabetes (CAIPaDi)
Phone: +52 5543705748
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
Carnot Laboratories
Registry
ClinicalTrials.gov
Start date
1 September 2026
Est. completion
1 October 2027
Where this trial is recruiting
🇲🇽 Mexico
Primary endpoints
Change in Hemoglobin A1c (HbA1c) From Baseline at Week 30
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 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.