Primary Sclerosing Cholangitis (PSC)Phase 2FEASTNCT07898839
FEAST and HOPE: Redox PSC Pilot Study
A Phase 2 study testing N-Acetyl Cysteine (NAC), Alpha-Lipoic Acid (ALA) and Nicotinamide Riboside (NR) in people with Primary Sclerosing Cholangitis (PSC), run by Brigham and Women's Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Sclerosing Cholangitis (PSC)
- What is being tested?
- N-Acetyl Cysteine (NAC), Alpha-Lipoic Acid (ALA) and Nicotinamide Riboside (NR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18 to 70 years
- Ulcerative colitis (UC) duration of at least 6 months, with diagnosis confirmed by typical endoscopic and histologic findings
- Primary sclerosing cholangitis (PSC) duration of at least 6 months, with diagnosis confirmed by typical cholangiogram findings and no evidence of a secondary cause of sclerosing cholangitis
- Simple Clinical Colitis Activity Index (SCCAI) of 5 or less
- Serum alkaline phosphatase (ALP) greater than 1.33 times the upper limit of normal (ULN)
- Platelet count greater than 150,000/mm³
Show all 14Show fewer
- Albumin greater than 3.3 g/dL
- Serum creatinine below ULN
- For participants on ursodeoxycholic acid (UDCA): stable dose for at least 3 months before screening. For participants not on UDCA: no UDCA use for at least 3 months before screening
- For participants on mesalamine or sulfasalazine: stable dose for at least 4 weeks before enrollment
- For participants on immunomodulators or biologic agents: stable dose for at least 8 weeks, and must remain on the same dose throughout the study
- For participants on oral corticosteroids: dose no greater than 20 mg prednisone or 6 mg budesonide daily at enrollment
- Willing and able to give informed consent before any study-specific procedures
- Willing and able to comply with scheduled visits, laboratory tests, stool collection, and other study procedures
Who cannot join
- Pregnant, or positive pregnancy test at screening
- Women of childbearing potential who intend to become pregnant during the study or within 1 month after the last dose of study medication
- Currently breastfeeding, or intending to breastfeed during the study or within 1 month after the last dose of study medication
- Women of childbearing potential unwilling to use protocol-specified contraception
- Alanine aminotransferase (ALT) greater than 5 times ULN
- Total bilirubin greater than 2 times ULN (unless history of Gilbert's syndrome)
Show all 28Show fewer
- International normalized ratio (INR) greater than 1.2
- Decompensated cirrhosis, defined by ascites, hepatic encephalopathy, or variceal bleeding
- Small duct PSC
- Secondary sclerosing cholangitis (e.g., due to chronic biliary obstruction, infection, ischemic injury, IgG4-related disease, drug- or toxin-induced cholangiopathy, or malignancy)
- Other causes of liver disease, including viral, metabolic, alcohol-related, and other autoimmune liver diseases. Participants with non-alcoholic fatty liver disease may be included if there is no evidence of non-alcoholic steatohepatitis (NASH)
- Positive antimitochondrial antibody (AMA)
- History of liver transplantation
- History of hepatocellular carcinoma or cholangiocarcinoma
- Ascending cholangitis within 90 days of enrollment
- Severe UC flare requiring intravenous corticosteroids within 3 weeks of enrollment or during the study, or anticipated new IBD medication within 3 months
- History of colectomy, ileal pouch, or ostomy, or anticipated colectomy within the next few months
- Positive stool culture, ova and parasites, or C. difficile toxin within 2 months of enrollment
- Use of antibiotics and/or probiotics within 6 weeks of enrollment, or planned use during the study
- Use of total parenteral nutrition or exclusive enteral nutrition at enrollment or during the study
- Current vegetarian or vegan diet
- Inability to complete a dietary log
- Participation in another therapeutic clinical trial within 30 days or 5 half-lives of the other study drug (whichever is longer) before screening, or concurrent participation in another therapeutic trial
- Any laboratory abnormality or condition that, in the investigator's opinion, could affect participant safety or the assessment of study results
- Current use of metformin, use within 8 weeks before enrollment, or anticipated start of metformin outside the study
- Estimated glomerular filtration rate (eGFR) below 50 mL/min/1.73 m² at screening
- Confirmed diagnosis of diabetes mellitus
- Known hypersensitivity to alpha-lipoic acid, N-acetylcysteine, nicotinamide riboside, metformin, or any excipient or capsule component of the study products
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: FEAST and HOPE: Redox PSC Pilot Study in PSC
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.
Read more
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:
- Does blocking disulfidptosis with the study diet and agents lower alkaline phosphatase (ALP)? ALP is a liver blood test that is often high in people with PSC.
- Does it change other blood markers of liver health and inflammation?
- What medical problems do participants have while on the study diet and agents?
There is no comparison group in this study. All participants will receive the study diet and all four agents.
Participants will:
- Have a screening visit to check if they can join the study
- Follow a study diet for the length of the study, with guidance from study dietitians
- Receive help from the study to buy groceries that fit the study diet
- Take photos of their meals and snacks using a phone app, so dietitians can review what they eat and give advice
- Take the four study agents by mouth each day, starting at lower doses that are raised step by step over the first weeks
- Visit the clinic in Boston about 11 times over about 18 weeks
- Give blood samples at study visits to check liver tests, safety tests, and other markers
- Answer questions about their health, symptoms, and any side effects
Researchers will watch closely for side effects throughout the study. If liver tests rise too much, researchers will follow set safety steps, which may include stopping one or more study agents. About 15 people will take part.
- Conditions
- Primary Sclerosing Cholangitis (PSC)
- Being tested
- N-Acetyl Cysteine (NAC), Alpha-Lipoic Acid (ALA), Nicotinamide Riboside (NR), Metformin Hydrochloride Extended-Release Tablets, Study Diet
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetyl Cysteine (NAC)Dietary supplement
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)Dietary supplement
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.
Nicotinamide Riboside (NR)Dietary supplement
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 TabletsDrug
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.
Study DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Diet Plus ALA, NAC, NR, and Metformin | Experimental | 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. Receives: Dietary Supplement: N-Acetyl Cysteine (NAC); Dietary Supplement: Alpha-Lipoic Acid (ALA); Dietary Supplement: Nicotinamide Riboside (NR); Drug: Metformin Hydrochloride Extended-Release Tablets; Other: Study Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline (Week 0) and Week 16
Secondary outcomes (4)
Change in Liver Biochemistry From Baseline to Week 16
Change in serum gamma-glutamyl transferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin from Baseline to Week 16.
Measured: Baseline (Week 0) and Week 16
Change in Pro-peptide of Type III Collagen (PRO-C3) From Baseline to Week 16
Serum PRO-C3 (ng/mL), a biomarker of liver fibrogenesis. Change from baseline to Week 16 is reported as absolute and percent change from baseline.
Measured: Baseline (Week 0) and Week 16
Change in Enhanced Liver Fibrosis (ELF) Score From Baseline to Week 16
The ELF score is a composite serum fibrosis score calculated from hyaluronic acid, amino-terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloproteinase 1 (TIMP-1). Change from baseline to Week 16 is reported as absolute and percent change from baseline.
Measured: Baseline (Week 0) and Week 16
Change in LMR Inflammatory Panel Markers From Baseline to Weeks 8 and 16
Serum inflammatory and metabolic markers measured using the LMR Inflammatory Panel. Change from baseline to Week 8 and to Week 16 is reported.
Measured: Baseline (Week 0), Week 8, and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing Cholangitis (PSC)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Korzenik, Brigham and Women's Hospital
- Investigators
- Joshua R Korzenik, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898839
- Sponsor's protocol ID
- 2026P002772
- Acronym
- FEAST
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FEAST and HOPE: Redox PSC Pilot Study in PSC
- ClinicalTrials.gov ID
- NCT07898839
- Acronym / sponsor ID
- FEAST / 2026P002772
- Conditions
- Primary Sclerosing Cholangitis (PSC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does blocking disulfidptosis with the study diet and agents lower alkaline phosphatase (ALP)? ALP is a liver blood test that is often high in people with PSC.
- Does it change other blood markers of liver health and inflammation?
- What medical problems do participants have while on the study diet and agents?
There is no comparison group in this study. All participants will receive the study diet and all four agents.
Participants will:
- Have a screening visit to check if they can join the study
- Follow a study diet for the length of the study, with guidance from study dietitians
- Receive help from the study to buy groceries that fit the study diet
- Take photos of their meals and snacks using a phone app, so dietitians can review what they eat and give advice
- Take the four study agents by mouth each day, starting at lower doses that are raised step by step over the first weeks
- Visit the clinic in Boston about 11 times over about 18 weeks
- Give blood samples at study visits to check liver tests, safety tests, and other markers
- Answer questions about their health, symptoms, and any side effects
Researchers will watch closely for side effects throughout the study. If liver tests rise too much, researchers will follow set safety steps, which may include stopping one or more study agents. About 15 people will take part.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Diet Plus ALA, NAC, NR, and Metformin | Experimental | Dietary Supplement: N-Acetyl Cysteine (NAC), Dietary Supplement: Alpha-Lipoic Acid (ALA), Dietary Supplement: Nicotinamide Riboside (NR), Drug: Metformin Hydrochloride Extended-Release Tablets, Other: Study DietSingle-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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Males and females aged 18 to 70 years
- Ulcerative colitis (UC) duration of at least 6 months, with diagnosis confirmed by typical endoscopic and histologic findings
- Primary sclerosing cholangitis (PSC) duration of at least 6 months, with diagnosis confirmed by typical cholangiogram findings and no evidence of a secondary cause of sclerosing cholangitis
- Simple Clinical Colitis Activity Index (SCCAI) of 5 or less
- Serum alkaline phosphatase (ALP) greater than 1.33 times the upper limit of normal (ULN)
Key exclusion criteria (28 listed)
- Pregnant, or positive pregnancy test at screening
- Women of childbearing potential who intend to become pregnant during the study or within 1 month after the last dose of study medication
- Currently breastfeeding, or intending to breastfeed during the study or within 1 month after the last dose of study medication
- Women of childbearing potential unwilling to use protocol-specified contraception
- Alanine aminotransferase (ALT) greater than 5 times ULN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Acetyl Cysteine (NAC)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. | Dietary supplement | Study Diet Plus ALA, NAC, NR, and Metformin |
| Alpha-Lipoic Acid (ALA)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. | Dietary supplement | Study Diet Plus ALA, NAC, NR, and Metformin |
| Nicotinamide Riboside (NR)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. | Dietary supplement | Study Diet Plus ALA, NAC, NR, and Metformin |
| Metformin Hydrochloride Extended-Release TabletsMetformin 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. | Drug | Study Diet Plus ALA, NAC, NR, and Metformin |
| Study DietParticipants 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. | Other | Study Diet Plus ALA, NAC, NR, and Metformin |
Primary outcome
Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 16
Time frame: Baseline (Week 0) and 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).
Percentage of Participants With ≥50% Reduction in Serum ALP at Week 16
Time frame: Baseline (Week 0) and 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.
4 secondary outcomes
Change in Liver Biochemistry From Baseline to Week 16
Time frame: Baseline (Week 0) and Week 16
Change in Pro-peptide of Type III Collagen (PRO-C3) From Baseline to Week 16
Time frame: Baseline (Week 0) and Week 16
Change in Enhanced Liver Fibrosis (ELF) Score From Baseline to Week 16
Time frame: Baseline (Week 0) and Week 16
Change in LMR Inflammatory Panel Markers From Baseline to Weeks 8 and 16
Time frame: Baseline (Week 0), Week 8, and Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua R Korzenik, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-Acetyl Cysteine (NAC), Alpha-Lipoic Acid (ALA) and Nicotinamide Riboside (NR) in people with Primary Sclerosing Cholangitis (PSC), run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua R Korzenik, MD (6177102351, jkorzenik@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 16 (time frame: Baseline (Week 0) and Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.