Phase 1 Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT06694935 Sponsor: 1Globe Health Institute Condition: Non-Alcoholic Fatty Liver Disease
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Phase 1 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT06694935
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:

  • You are between 18 and 64 years old
  • Your body weight falls within a healthy to moderately obese range (BMI between 18 and 44.9)
  • You have been diagnosed with Type 2 diabetes according to 2021 American Diabetes Association guidelines
  • You have been diagnosed with a liver condition called NAFLD (a build-up of fat in the liver not caused by alcohol)
  • If you are able to have children, you must be willing to use contraception during the study
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before joining
  • Your kidney function is within an acceptable range based on blood test results (confirm with trial site)
  • You are able to follow all study requirements and attend appointments as needed
  • You have signed a consent form agreeing to take part

Who may not be able to join:

  • Your diabetes is not well controlled
  • You have a serious ongoing illness that affects your ability to carry out everyday activities
  • You currently drink significant amounts of alcohol, or have done so in the past
  • Your blood fat (triglyceride) levels are very high (above 500 mg/dL)
  • Your LDL ("bad") cholesterol levels are very high (above 190 mg/dL)
  • Certain liver-related blood test results are significantly above the normal range (confirm with trial site)
  • Your long-term blood sugar control measurement (HbA1c) is above 10.5%
  • Your fasting blood sugar level is above 240 mg/dL
  • Your platelet count (cells that help blood clot) is below a certain level
  • You take medications known to be linked to NAFLD or that can harm the liver
  • You take vitamin E supplements above 400 IU per day, or herbal supplements that may affect NAFLD

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 26 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: Andrew Keates, PhD, 1Globe Health Institute

Phone: 617-649-1157

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
1Globe Health Institute
Registry
ClinicalTrials.gov
Start date
6 January 2025
Est. completion
1 July 2025

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Recommended Phase 2 Dose (RP2D)

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: 26 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