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Amino Acids

Amino Acids for Fatty Liver Disease (AMINOS Trial)

Phase 3

Recruiting

Led By Melanie Cree, MD, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 13-18, Tanner stage 4-5

BMI equal or greater than the 85th percentile for age and gender, this is overweight and obese categories

Must not have

Use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications

Diabetes, defined as Hemoglobin A1C > 6.4%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 8 weeks

Awards & highlights

Pivotal Trial

Summary

This trial will study teenagers with liver fat by giving them either a protein supplement or a fake supplement for 2 months to see if the protein supplement helps reduce liver fat. After this initial phase, all

Who is the study for?

Adolescents aged 13-18 with fatty liver disease, specifically non-alcoholic fatty liver disease (NAFLD), who are overweight and do not exercise much. They must have a confirmed diagnosis by biopsy and be in the later stages of puberty. Those who are very active or don't meet the specific medical criteria cannot join.

What is being tested?

The study is testing if an essential amino acid supplement can reduce liver fat in teens with NAFLD compared to a placebo over two months. After this period, all participants will receive the actual supplement for ten more months.

What are the potential side effects?

Potential side effects may include digestive discomfort or allergic reactions to the ingredients in the amino acid supplement; however, these supplements are generally considered safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 13 and 18 years old and have advanced in puberty.

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My BMI is in the overweight or obese range for my age and gender.

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I have been diagnosed with non-alcoholic fatty liver disease by a liver specialist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently taking medications that affect insulin sensitivity.

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My last A1C level was above 6.4%, indicating diabetes.

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My hemoglobin level is below 11 mg/dL.

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I do not have liver disease, except for NAFLD, and my liver enzymes are not above 150 IU/L.

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I have not been hospitalized for a severe illness in the last 60 days.

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My BMI is below the 85th percentile for my age and sex, and my waist is over 200 cm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Hepatic Fat Fraction

Secondary study objectives

Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

Change in alanine aminotransferase (ALT)

Change in aspartate aminotransferase (AST)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Amino Acid SupplementActive Control1 Intervention

Participants are blindly randomized and for this arm, participants will take the Essential Amino Acid Supplement for 2-months, followed by an open label extension period of 10-months of Essential Amino Acid for all participants

Group II: PlaceboPlacebo Group1 Intervention

Participants are blindly randomized and for this arm, participants will take the Placebo for 2-months, followed by an open label extension period of 10-months of Essential Amino Acid for all participants

0 / 9Eligibility criteria met