BridgeMD
New treatment option for Hepatic Steatosis
Official title Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
ClinicalTrials.gov ID: NCT05935826
What this study is testing
What is Essential Amino Acid Supplement by Amino Co?
Essential Amino Acid Supplement by Amino Co is an investigational medicine, given as an once-daily, being studied as a potential treatment for hepatic steatosis.
Also referred to as Essential Amino Acid Supplement (EAA), AMS22392.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Participants 13-18 years of age with extra fat stored in the liver will be randomly assigned to a protein supplement or placebo "fake supplement" for 2 months to see if the participants who get the protein supplement have less fat in the liver compared to participants who were in the placebo group. After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 18
You may be able to join if
- Ages 13-18, Tanner stage 4-5
- Suspected or diagnosed with NAFLD per fibroscan or liver biopsy within 6 months prior to enrollment as long as participants have not lost more than...
- Diagnosis of non-alcoholic fatty liver disease (NAFLD) per hepatologist
- Sedentary- less than 3 hours of moderate (jogging, swimming, etc.) exercise a week
- BMI equal or greater than the 85th percentile for age and gender, this is overweight and obese categories
You likely can't join if
- Use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant...
- Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study
- Severe illness requiring hospitalization within 60 days
- Diabetes, defined as Hemoglobin A1C \> 6.4%
- BMI percentile less than the 85th percentile for age and sex. Waist circumference \>200 cm
- Anemia, defined as Hemoglobin \< 11 mg/dL
See the full eligibility criteria
- Ages 13-18, Tanner stage 4-5
- Suspected or diagnosed with NAFLD per fibroscan or liver biopsy within 6 months prior to enrollment as long as participants have not lost more than 5% of total body weight. Their MRI liver fat \>5.5%
- Diagnosis of non-alcoholic fatty liver disease (NAFLD) per hepatologist
- Sedentary- less than 3 hours of moderate (jogging, swimming, etc.) exercise a week
- BMI equal or greater than the 85th percentile for age and gender, this is overweight and obese categories
- Use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications.
- Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study
- Severe illness requiring hospitalization within 60 days
- Diabetes, defined as Hemoglobin A1C \> 6.4%
- BMI percentile less than the 85th percentile for age and sex. Waist circumference \>200 cm
- Anemia, defined as Hemoglobin \< 11 mg/dL
- Diagnosed major psychiatric or developmental disorder limiting informed consent
- Implanted metal devices that are not compatible with MRI
- Use of blood pressure medications
- Known liver disease other than NAFLD or AST or ALT \>150 IU/L
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.