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FEAST
Sponsor study identifier
interventional
15
0 countries
N/A
Study Start
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to test whether a type of cell death called disulfidptosis plays a role in primary sclerosing cholangitis (PSC) in adults aged 18 to 70. Researchers will do this by giving participants a study diet and four oral agents designed to block disulfidptosis, then checking whether liver blood tests change. This study is not designed to show that the combination treats PSC. PSC is a long-term liver disease. In PSC, the bile ducts become inflamed and scarred over time. Bile ducts are small tubes that carry bile from the liver to the gut. Researchers are testing a new idea about why bile duct cells are damaged in PSC. Cells need a balance of certain sulfur-containing building blocks and the energy to process them. When this balance breaks down, proteins inside the cell can stick together the wrong way. This can cause the cell's inner structure to collapse, and the cell dies. This type of cell death is called disulfidptosis. Researchers think disulfidptosis may contribute to bile duct damage in PSC. This is a proof-of-principle study. This means it is an early, small study to test whether this idea is correct and worth studying further. Participants will follow a study diet and take four oral agents. Each agent was chosen because it may help protect cells from disulfidptosis: Alpha-lipoic acid (ALA), a natural antioxidant that helps cells manage stress N-acetylcysteine (NAC), which helps the body make glutathione, a natural antioxidant Nicotinamide riboside (NR), a form of vitamin B3 that helps cells make energy Metformin, a common diabetes medicine that changes how cells use sugar and energy The main questions it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2026
Actual (reported)October 27, 2026
Actual (reported)January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 16
Serum ALP (U/L) will be measured at Baseline and Week 16. Change will be calculated as the Week 16 value minus the Baseline value. ALP is a marker of cholestatic liver injury commonly elevated in primary sclerosing cholangitis (PSC).
Baseline (Week 0) and Week 16
Percentage of Participants With ≥50% Reduction in Serum ALP at Week 16
ALP response is defined as a reduction of 50% or more from baseline at Week 16. Reported as the proportion of participants achieving response, with 95% confidence interval.
Baseline (Week 0) and Week 16
Change in Liver Biochemistry From Baseline to Week 16
Baseline (Week 0) and Week 16
Change in Pro-peptide of Type III Collagen (PRO-C3) From Baseline to Week 16
Baseline (Week 0) and Week 16
Change in Enhanced Liver Fibrosis (ELF) Score From Baseline to Week 16
Baseline (Week 0) and Week 16
Change in LMR Inflammatory Panel Markers From Baseline to Weeks 8 and 16
Baseline (Week 0), Week 8, and Week 16
Single-arm, open-label. All participants follow a study diet and take four oral agents targeting disulfidptosis for approximately 16 weeks (Baseline through Week 16). Study diet: guided by study dietitians, with grocery support and meal photo logging via the MetaBite app. Study agents: alpha-lipoic acid (ALA) 600 mg once daily in Week 0, then 600 mg twice daily from Week 1; N-acetylcysteine (NAC); nicotinamide riboside (NR) 500 mg twice daily; and metformin extended-release, with doses titrated over the initial weeks per protocol. Enrollment is stratified by inflammatory bowel disease (IBD) status. Study agents may be withdrawn sequentially per the protocol-defined ALP management plan.
N-acetylcysteine (NAC) capsules (Pure Encapsulations), taken orally. Dose: 1200 mg/day through Week 16. Selected as a precursor of glutathione to support cellular thiol and redox balance as part of a regimen targeting disulfidptosis.
Alpha-lipoic acid (ALA) capsules (Pure Encapsulations), taken orally. Dose: 600 mg once daily in Week 0, then 600 mg twice daily from Week 1 through Week 16. Selected to support cellular antioxidant capacity and redox balance as part of a regimen targeting disulfidptosis.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Metformin Hydrochloride Extended-Release Tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Metformin Hydrochloride Extended-Release Tablets
Named ingredient: Metformin hydrochloride
View registry recordJoshua R Korzenik, MD
Brigham and Women's Hospital
First Submitted
October 21, 2026
First Posted
October 27, 2026
Study Start
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 2028
Nicotinamide riboside (NR) chloride 250 mg capsules (Tru Niagen, ChromaDex), taken orally. Dose: 500 mg twice daily (1,000 mg/day) through Week 16. Selected as an NAD+ precursor to support cellular NADPH availability as part of a regimen targeting disulfidptosis.
Metformin hydrochloride extended-release 500 mg tablets (Granules Pharmaceuticals), taken orally. Dose titrated per protocol to 1000 mg through Week 16. Selected for its effects on cellular glucose and energy metabolism as part of a regimen targeting disulfidptosis.
Participants follow a protocol-specified study diet from Baseline through Week 16, guided by study dietitians. Dietary intake is recorded through meal photographs using the MetaBite for Research app, which dietitians review to provide individualized recommendations. Participants receive grocery support to facilitate adherence.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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