A Phase 2 interventional study of Standard Soy Milk and 2% Fat Cow's Milk in Non-Alcoholic Fatty Liver Disease, sponsored by Marialena Mouzaki. Recruiting at 1 site in United States. Open to participants aged 5 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Marialena Mouzaki · Phase 2, Interventional, and Treatment
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Among 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States — 60 open to participants now, 93 under way, 13 of them phase 3. Non-alcoholic Fatty Liver Disease · United States.
Among the 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States, this one is the 275th largest by planned enrollment of the 460 interventional ones that give a count, is one of 29 that started in 2024, is one of 192 in phase 2, reaches primary completion later than 56 of the 92 other live ones, and was the 495th registered.
1,618 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 323 are open to participants now.
Browse Non-alcoholic Fatty Liver Disease studies →60 of the 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Ages 18–75
Regeneron Pharmaceuticals · Sites in United States, Puerto Rico, United Kingdom
Ages 18–75
Columbia University · Sites in United States
Ages 18–65
Regeneron Pharmaceuticals · Sites in United States
Ages 18–75
GlaxoSmithKline · Sites in United States
Ages 18–70
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 220 Non-alcoholic Fatty Liver Disease studies recruiting now, 66 (30%) set no upper age limit and 125 (57%) stop at 75 or younger; 27 take children under 18; 55 take healthy volunteers.
This study: 5 Years to 16 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
547 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 93 · Phase 2 213 · Phase 3 36 · Phase 4 13
First in 2000; this study’s year is marked. 29 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 44 is below the median of 60 across 1,177 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Median enrollment 56 across the 460 interventional studies, 90 across the 85 observational. Of the 420 that completed or were terminated, 215 (51%) have results posted.
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246 of 547 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Marialena Mouzaki as lead sponsor.
Marialena Mouzaki has 1 study filed under Non-alcoholic Fatty Liver Disease — fewer than ten, so there is no comparison to draw.
22 of the studies in Non-alcoholic Fatty Liver Disease with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04951219Phase 3Madrigal Pharmaceuticals, Inc.A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE) | 2027-03 |
| NCT04833140Phase 3Massachusetts General HospitalEstrogen Administration for the Treatment of NASH in Postmenopausal Women | 2027-07-09 |
| NCT00983463Vanderbilt UniversityAbundance and Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease (NAFLD) | 2026-11 |
| NCT05165706Stanford UniversityLongitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance | 2026-11-30 |
| NCT05067621Yale UniversitySemaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease | 2026-12 |
Add all 22 to your calendar (.ics) → With an account.
Among the 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A randomized, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD). The investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing NAFLD and other obesity-related comorbidities. The investigators do not expect any adverse endocrine or metabolomic effects from the consumption of soy isoflavones.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks.
Drug: 2% Fat Cow's Milk
Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks.
Drug: Standard Soy Milk
Consumption of commercially available soy milk
Consumption of commercially available 2% cow's milk
Change in liver disease severity
Change in liver disease severity, measured using magnetic resonance imaging-proton density fat fraction (MRI-PDFF). A relative PDFF change of 30% correlates with histologic improvement in patients with NAFLD and is commonly used in clinical trials.
Time frame: 12 weeks
Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP])
Time frame: 12 weeks
Change in gamma glutamyl-transferase levels (GGT)
Time frame: 12 weeks
Change in alkaline phosphatase (ALP)
Time frame: 12 weeks
Change in fasting triglycerides
Time frame: 12 weeks
Change in total cholesterol (TC)
Time frame: 12 weeks
Change in high- and low-density lipoprotein (HDL-C, LCL-C) levels
Time frame: 12 weeks
Change in glucose
Time frame: 12 weeks
Change in insulin
Time frame: 12 weeks
Change in glycated hemoglobin (HbA1c)
Time frame: 12 weeks
Change in testosterone, estrogen and sex hormone binding globulin (SHBG) levels
Time frame: 12 weeks
Change in thyroid function (TSH and Free T4)
Time frame: 12 weeks
Change in estradiol
Time frame: 12 weeks
Change in serum metabolome and lipidome
Time frame: 12 weeks
Change in systolic and diastolic blood pressure
Time frame: 12 weeks
Change in equol production status
Time frame: 12 weeks
Started Jan 2024 (actual). Primary completion is estimated for Mar 2028, 50 months after the start.
Of 53 non-industry phase 2 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 56. This study's planned 50 months is above that.
Counting every sponsor, half of 185 studies reached it within 26 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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Non-alcoholic Fatty Liver Disease →