Recruiting

Testing a protein supplement to reduce fat in teenage livers

Plain-English translation of NCT05935826 on ClinicalTrials.gov ↗ · Source last updated August 2025 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing whether an Essential Amino Acid Supplement can help reduce the amount of fat stored in the liver in teenagers with fatty liver disease. Half of the participants will take the medication for 2 months, while the other half will take a placebo (a fake pill that looks identical). After 2 months, everyone in the study will have the option to continue and receive the actual medication for an additional 10 months.

Fatty liver disease in teenagers is becoming more common and there aren't many proven treatments available yet. Researchers think this medication might help because amino acids (the building blocks of protein) could help the liver process fat more effectively, but this needs to be tested carefully in young people.

Do you qualify?

You likely qualify if…

you are between 13 and 18 years old and have reached late puberty
you have been diagnosed with fatty liver disease or have imaging showing fat in your liver (more than 5.5%)
you are overweight or obese (BMI at or above the 85th percentile for your age and gender)
you exercise less than 3 hours per week of moderate activity like jogging or swimming
you have not lost more than 5% of your body weight in the past 6 months

You likely don't qualify if…

you are currently taking medications that affect how your body processes sugar, such as metformin or certain psychiatric medications
you are pregnant, breastfeeding, or planning to become pregnant during the study
you have diabetes or pre-diabetes (hemoglobin A1C higher than 6.4%)
you have had severe illness requiring hospitalization within the past 60 days
you have metal implants in your body that are not compatible with MRI machines

What participation looks like

You'll visit the research center at the start and end of the study to have an MRI scan (to measure liver fat), a body X-ray (to measure body composition), and a blood draw. During the 2-month treatment phase, you'll take either the medication or a placebo twice daily at home — neither you nor the researchers will know which one you're taking. If you wish to continue, all participants then receive the actual medication for 10 additional months.

AI-generated summary from trial data · Jun 9, 2026 · Not medical advice

Trial locations(1 site)

United States

Univeristy of Colorado Anschutz Medical Campus, Aurora, Colorado