Phase 1 Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT07335198 Sponsor: GlaxoSmithKline Condition: Non-Alcoholic Fatty Liver Disease
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Phase 1 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT07335198
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 generally in good health, as confirmed by a medical check-up
  • You weigh at least 50 kg (about 110 lbs) if you are male, or at least 45 kg (about 99 lbs) if you are female
  • Your Body Mass Index (BMI — a measure of body weight relative to height) is between 18.0 and 28.0
  • Both men and women are welcome to apply
  • You are of Chinese ancestry, were born in mainland China, Hong Kong, or Taiwan, and have lived outside those places for less than 10 years at the time of screening
  • You are of Japanese ancestry, were born in Japan, have two Japanese parents and four Japanese grandparents, and have lived outside Japan for less than 10 years at the time of screening
  • You identify as being of White/European ancestry (from the original peoples of Europe), regardless of where you currently live, and have two parents and four grandparents of White/European ancestry

Who may not be able to join:

  • You have a history of conditions that could significantly affect how your body absorbs, processes, or removes medicines (confirm with trial site)
  • You have a current or long-term history of liver or bile duct disease — except for a condition called Gilbert's syndrome or gallstones that cause no symptoms
  • You have a history of pancreas injury, pancreatitis, or other pancreatic disease; Type 1 Diabetes; or serious complications from Type 2 Diabetes such as severe stomach-emptying problems or nerve damage
  • Your blood pressure is too high — specifically, the top number is 140 or above, or the bottom number is 90 or above
  • You have a history of bone conditions such as osteoporosis, low bone density (osteopenia), or softening of the bones (osteomalacia)
  • You have had any type of cancer in the past 5 years, except for a specific minor form of skin cancer (localised basal cell carcinoma)
  • Certain liver-related blood test results are above acceptable levels (confirm with trial site)
  • You have a known bleeding disorder
  • You have a history of immune system diseases, or you have tested positive for HIV
  • Your heart's electrical activity (measured by an ECG) shows a reading that is too high — 450 msec or above for men, or 470 msec or above for women
  • You are currently taking cholesterol-lowering (statin) medications or blood pressure medications, unless you have been on a stable dose for at least 3 months
  • You have taken part in another drug trial recently, or are currently taking an experimental drug (confirm with trial site for exact timeframes)
  • You have ever received a treatment involving a substance called FGF21 or a similar drug
  • You plan to take or are currently taking any over-the-counter, prescription, or herbal medicines within 7 days before your dose and throughout the study
  • You have received a live vaccine within 14 days before dosing, or a non-live vaccine within 7 days before dosing
  • You are currently enrolled in or have taken part in another clinical trial within the last 30 days
  • You have tested positive for Hepatitis B or Hepatitis C at screening or within 3 months before the study
  • You have tested positive for drugs or alcohol in a pre-study screening test

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 14 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: GSK Clinical Trials, GlaxoSmithKline

Phone: 877-379-3718

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
5 March 2026
Est. completion
17 August 2026

Where this trial is recruiting

🇳🇿 New Zealand

Primary endpoints

Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs); Number of participants with clinically significant changes in hematology, chemistry and urinalysis parameters; Number of participants with clinically significant changes in 12 Lead electrocardiogram (ECG); Number of participants with clinically significant changes in vital signs; Area under the serum drug concentration versus time curve from time zero to the time of the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa; Area under the serum drug concentration versus time cur...

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: 14 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