Phase 1 Type 1 Diabetes Trial, Recruiting NCT06562907 Sponsor: Gilead Sciences Condition: Type 1 Diabetes
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Phase 1 Type 1 Diabetes Trial, Recruiting

NCT06562907
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 who have never used a GLP-1 receptor agonist medication (a type of diabetes/weight loss drug), or whose last dose of one was at least 6 months before the screening visit.
  • For Parts A and B (single-dose and food/medication effect testing): People who are generally healthy, with a BMI between 19 and 30, no significant medical history, and who are considered in good health by the study doctor at a check-up within 28 days before the first dose.
  • For Part C (multiple-dose testing in people with obesity who do not have diabetes): People with a BMI between 30 and 45, a total body weight over 50 kg, no diabetes (based on a blood sugar marker called HbA1c being below 6.5%), and whose weight has been stable (less than 5% change) for at least 90 days before screening.
  • For Part D (multiple-dose testing in people with type 2 diabetes who are not obese): People with type 2 diabetes, an HbA1c blood sugar level between 7.0% and 10.5%, a BMI between 19 and 30, and who manage their diabetes through diet and/or exercise alone, or with metformin as their only medication.

Who may not be able to join:

  • People with a serious or active physical or mental health condition (including depression) that the study doctor believes could interfere with the study, including a history of pancreatitis, gallbladder disease, kidney, heart, blood, liver, lung (including chronic asthma), hormonal, nerve, digestive, vascular, immune, thyroid, adrenal, or metabolic conditions, active infection, or cancer that is clinically significant or needs treatment.
  • People who currently have symptoms of diabetic eye disease (diabetic retinopathy), or who had an eye examination showing this condition within the past year.
  • People found to have a significant imbalance in certain minerals in their blood (such as low potassium, calcium, or magnesium) at the screening visit.
  • People with a condition that the study doctor believes could cause mineral imbalances in the blood, such as an eating disorder.
  • People with a history of fainting, heart palpitations, or unexplained dizziness.
  • People with a current or past significant heart condition or abnormal heart rhythm.
  • People who have had a pacemaker or defibrillator implanted.
  • People who have used GLP-1 receptor agonist medications, systemic steroids, immunosuppressant therapies, or chemotherapy agents in the 6 months before screening, or who are expected to use these during the study.
  • People who previously stopped using a GLP-1 receptor agonist medication because of severe side effects such as nausea, constipation, diarrhoea, or vomiting.

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 23 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: Gilead Study Director, Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

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
Registry
ClinicalTrials.gov
Start date
28 August 2024
Est. completion
1 November 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Single-Dose PK Parameter AUCinf of GS-4571; Single-Dose PK Parameter Cmax of GS-4571; Multiple-Dose Plasma PK Parameter: AUCtau of GS-4571; Multiple-Dose Plasma PK Parameter: Cmax of GS-4571; Percentage of Participants of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths; Percentage of Participants of Treatment-Emergent Laboratory Abnormalities

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: 23 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