Phase 1 Type 1 Diabetes Trial, Recruiting NCT07675590 Sponsor: TIXiMED, Inc. Condition: Type 1 Diabetes
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Phase 1 Type 1 Diabetes Trial, Recruiting

NCT07675590
Recruiting Phase 1

Who may 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 might be able to join this trial:

  • People aged 18 to 70 years, of any gender, who are considered generally healthy by the trial doctor based on a medical check-up, blood tests, heart monitoring, and breathing assessment.
  • People with no significant recent illness or surgery in the past 12 weeks, and no significant history of serious conditions affecting the nervous system, heart, lungs, kidneys, liver, digestion, blood, immune system, hormones, or mental health.
  • Male participants with a female partner who could become pregnant must agree to use condoms for the whole duration of the study.
  • Female participants who could become pregnant must have a negative pregnancy test and agree to use two forms of contraception during the study — one primary method (such as the pill, a hormonal implant, or an intrauterine device) and one barrier method (such as a condom and/or spermicide).
  • Female participants who cannot become pregnant due to surgical procedures or being postmenopausal (no periods for 12 months without another medical reason) are also eligible.
  • People with a Body Mass Index (BMI) between 25 and 34.9 (a measure of weight relative to height, confirm with trial site if unsure).
  • People with an HbA1c blood sugar level below 6.5% (a measure of average blood sugar over recent months).
  • People who are willing and able to follow all study requirements.

Who may not be able to join:

  • People with a history of heavy alcohol use (more than 21 drinks per week for males or more than 14 drinks per week for females), recreational drug use in the past three months, or a positive result on a urine drug test.
  • People who are pregnant or have been breastfeeding within six months of the screening visit.
  • People who have made significant changes to their diet or exercise habits in the past three months.
  • People with a history of eating disorders.
  • People whose weight has changed by more than 5% in the past three months.
  • People who have had weight-loss (bariatric) surgery within the past five years.
  • People with significantly reduced kidney function (confirm with trial site).
  • People with elevated liver enzyme levels on repeated blood tests (confirm with trial site).
  • People with conditions that affect metabolism or eating behaviour, such as an underactive thyroid, Cushing's disease, schizophrenia, major psychosis, or unmanaged depression.
  • People currently taking any prescription medications during the screening period or planned trial duration.
  • People currently using any medication approved for treating obesity.
  • People with any clinically significant abnormal findings on physical examination or laboratory tests, as determined by the trial doctor.
  • People with a specific abnormality on their heart tracing (ECG) known as prolonged QT interval, or a personal or family history of certain unexplained heart conditions (confirm with trial site).
  • People who have participated in another clinical drug trial within the three months before this study begins.

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.
Last synced 20 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Anath Shalev, MD, TIXiMED, Inc.

Phone: 619-799-4818

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
Recruiting
Phase
Phase 1
Sponsor
TIXiMED, Inc.
Registry
ClinicalTrials.gov
Start date
22 June 2026
Est. completion
1 October 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and Tolerability

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

View original record on ClinicalTrials.gov