Non-Alcoholic SteatohepatitisPhase 2NCT03884075
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
A Phase 2 study testing Semaglutide in people with Non-Alcoholic Steatohepatitis and Non-Alcoholic Fatty Liver Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: In non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication can help. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2019to 2 Oct 2028
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female Aged >= 18 years of age.
- Histological evidence of hepatic steatosis on a liver biopsy within 12 months OR evidence of fatty liver disease, as documented by imaging (ultrasound, CT, MRI, MRI-PDFF, MR spectroscopy, or Fibroscan CAP >= 285 db/M25) within 12 months.
- Estimated average alcohol consumption < 30 g/d for men or < 20 g/d for women in the 6 months prior to enrollment and no binge-drinking behavior.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Additional Inclusion Criteria for Treatment Phase
- Presence of NAFLD (steatosis grade greater than or equal to 1 on NASH-CRN scoring scale) on baseline admission liver biopsy.
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- Liver fat content greater than or equal to 10% by 1H-MRS on initial admission.
- Male or female Aged greater than or equal to 18 years of age.
- No evidence of hepatic steatosis by imaging or histology.
- No history of known liver disease.
- Individuals on regular systemic medications may be considered eligible, and their eligibility will be determined by the principal investigator.
- BMI less than or equal to 25 kg/m2
- Non-diabetic.
- Normal transaminases (ALT less than or equal to 31 U/L for men or less than or equal to 19 U/L for women, and AST less than or equal to 30 U/L).
- Fasting glucose less than or equal to 95 mg/dL.
- Ability of subject to understand and the willingness to sign a written informed consent document.
Who cannot join
- Pregnant or breast-feeding
- Chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who were treated successfully for HCV and achieved sustained virological response can be eligible for enrollment > 18 months after treatment cessation. Patients receiving antiviral therapy are ineligible.
- HIV infection.
- Concomitant liver disease such as autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson s disease, alpha-1 antitrypsin deficiency, hereditary hemochromatosis.
- Presence of definite or probable drug-induced liver injury. In the case of lipid-lowering, anti-hypertensive or anti-diabetic medications that are suspected to cause aminotransferase elevation, patients will be eligible if treatment is associated with stable enzyme levels for at least 6 months.
- Decompensated advanced liver disease, defined as direct bilirubin > 0.5 g/dL, PT > 18 , albumin < 3 g/dL, MELD score > 12 (applicable only in patients without Gilbert s syndrome), or history of ascites, encephalopathy, variceal bleeding, spontaneous bacterial peritonitis or liver transplant
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- Treatment with medications known to cause fatty liver disease such as atypical neuroleptics, tetracycline, methotrexate or tamoxifen
- Uncontrolled hypo- or hyperthyroidism.
- Thyroid nodules with ultrasonographic features suggestive of an increased risk of thyroid cancer per radiologist reporting (hypoechoic, microcalcifications, twinkling on B flow imaging, central vascularity, irregular margins, incomplete halo, nodule taller than wide and documented enlargement of a nodule), or nodules associated with an abnormal TSH (0.4 to 5 mU/L).
- Active coronary artery disease, defined as persistent angina pectoris, reversible ischemia on cardiac stress test or imaging, or the presence of significant coronary artery disease on imaging or catheterization. Patients with coronary artery disease that was treated by angioplasty or bypass surgery may be eligible if they have no evidence of active disease >= 1 year after intervention, can safely stop antiplatelet and anticoagulant medications before the performance of invasive procedures, and have adequate ventricular function as assessed by echocardiography or cardiology consultation. These patients will require cardiology consultation and clearance prior to enrollment.
- Congestive heart failure.
- Chronic kidney disease, with creatinine clearance < 60 ml/min or eGFR < 60/ml/min/m(2).
- Uncontrolled diabetes mellitus with HbA1c > 9% will exclude subjects. Patients with diabetes may be enrolled only if they have HbA1c <=9%, have been on stable therapy with lifestyle and/or metformin for at least 3 months prior to enrollment, and are not foreseen to require change of antidiabetic medication or dose during the trial.
- Use of insulin, sulfonylurea agents, thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists or DPP-4 inhibitors unless discontinued greater than or equal to 3 months before enrollment.
- Contraindication or inability to perform a liver biopsy.
- Patients with coagulopathy (PT/PTT values that are prolonged greater than or equal to 3 seconds from the upper limit of the normal, including treatment with oral and parenteral anticoagulants), thrombocytopenia (< 70,000), abnormal bleeding time or platelet dysfunction. Antiplatelet agents taken for cardiovascular prevention will not exclude patients, unless they cannot be stopped safely for the performance of a liver biopsy.
- Hemoglobin level < 11 g/dL
- Contraindications to MRI (heart pacemakers, unless MRI safe, insulin pumps, implanted hearing aids, neurostimulators, intracranial metal clips, metallic bodies in the eye, metal hip replacements, sutures, extreme anxiety or fear of small spaces.)
- History of gastric bypass or other bariatric surgery, partial or complete gastrectomy and known maldigestion or malabsorption.
- Treatment with orlistat.
- Patients with uncontrolled eating disorders including anorexia and bulimia nervosa.
- Patients with proliferative diabetic retinopathy.
- Use of medications or supplements to treat NAFLD (approved or unapproved) unless withdrawn greater than or equal to 3 months prior to enrollment or taken at a stable dose for greater than or equal to 6 months.
- Patients who had a liver biopsy performed less than or equal to 2 years before enrollment, unless they are willing to undergo all of the trial biopsies, knowing that these biopsies are purely for research and are not clinically indicated. This will be clearly documented in the patients charts prior to enrollment.
- Inability or unwillingness to receive subcutaneous injections.
- Known or suspected allergy to trial medication(s), excipients, or related products.
- Alcohol or substance abuse within the past 12 months.
- For women of childbearing potential, breast-feeding, pregnancy or inability or unwillingness to practice contraception for the duration of the study.
- Personal or first-degree family member with history of medullary thyroid carcinoma or subjects with known multiple endocrine neoplasia syndrome type 2 (MEN-2).
- Actively pursuing an intensive weight loss regiment, aimed at losing > 10% of current body weight, by following a different diet or exercise regimen over the study time period or recent (<3 months) significant weight loss (>10%).
- The receipt of any investigational drug within 3 months prior to enrollment in this trial.
- Assessment by the principal investigator that the subject will be unlikely to complete the study procedures, or that enrollment puts the subject at a significant risk unspecified by the criteria above.
- Pregnant or breastfeeding
- Excessive alcohol consumption, defined as an average alcohol consumption over > 1 drink per day over the past month
- Assessment by the principal investigator that the subject is unsuitable for participation in the study or that enrollment puts the subject at significant risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
Official title: Non-Alcoholic Fatty Liver Disease, the Hepatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
Background:
In non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication can help.
Read more
Objective:
To find out how the liver in people with NAFLD responds to feeding, and how this relates to their response to the drug semaglutide.
Eligibility:
People with NAFLD and healthy volunteers ages 18 and older
Design:
Participants will be screened with:
Medical history
Physical exam
Blood tests
Imaging: A machine will take pictures of the participant s body.
Within 2-8 weeks of enrollment, participants will stay in the clinic for several days. This includes:
Blood, urine, heart, and imaging tests
For NAFLD participants only: A needle-like device will remove a small biopsy of the liver and fatty tissue.
Participants will be alone in a special room for 5 hours. They will breathe through a tube under the nostrils. They will have blood drawn several times.
The baseline visit concludes participation for healthy volunteers but NAFLD participants will contine.
About 6 weeks after discharge, participants will stay in the clinic again and repeat the tests. They will get their first semaglutide dose by injection.
Participants will have visits weeks 1, 2, 4, 8, 12, 16, 20, and 24 of treatment. Visits include blood tests.
Participants will inject semaglutide once a week at home.
At week 30, participants will stay in the clinic again and repeat the tests.
Participants will have a final visit 12 weeks after stopping treatment. This includes blood and urine tests.
...
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) and its progressive form, non-alcoholic steatohepatitis (NASH), are leading causes of liver injury and are tightly associated with obesity, diabetes and the metabolic syndrome. Despite recent advances, there is still a considerable knowledge gap regarding the fundamental pathogenic mechanisms, and especially regarding the transition from benign steatosis to steatohepatitis. Although NAFLD reflects disordered energy metabolism in the liver, little information exists on the response of the human liver to the acute caloric load of a meal. We hypothesize, based on preliminary non-invasive results, that in patients with NAFLD, an oral carbohydrate load results in preferential de novo lipogenesis (due to selective insulin resistance) and generation of fatty acids (FA). We further hypothesize a spillover effect, wherein NASH patients have an impairment of the hepatic ability to esterify the load of FA to triglycerides (TG) compared to patients with steatosis, resulting in accumulation of lipotoxic intermediary metabolites.
GLP-1 receptor agonists (GLP-1RA) have demonstrated significant benefit in the treatment of diabetes and obesity. Liraglutide was shown in a prospective trial to improve NASH histology and other GLP-1RA have shown benefit in secondary analyses, consistent with a class effect. However, response rates to GLP-1RA, as well as to other pharmacological interventions in NAFLD, have not exceeded 50%, and there are no adequate baseline predictors of response that could allow for selection of subjects for personalized treatment. Given that GLP-1RAs exert their main activity in the post-prandial state, it is plausible that post-prandial parameters may be more effective in predicting treatment response and can shed light on its mechanism.
Our aims in this study are (1) to assess the hepatic response to an acute oral carbohydrate load; (2) to identify which baseline parameters can predict the clinical response of NAFLD patients to a course of semaglutide, a novel GLP-1RA.
We propose a non-randomized, single-center, pilot exploratory study in which 32 subjects with steatosis (12-20) or NASH (12-20) will initially undergo two liver biopsies, one in the fasting state and one performed 2 hours after an oral 75g glucose load (OGTT biopsy). Tissue samples obtained will be subjected to a comparative, paired analysis of gene expression, protein phosphorylation in key signaling pathways, composition of tissue lipid species and oxidative stress. Subjects will be treated with semaglutide (escalated to 1 mg/week) for 30 weeks in all subjects, and their clinical response will be assessed by ALT and 1H-Magnetic resonance spectroscopy and a final (3rd) liver biopsy. Clinical responders will be compared to non-responders with regards to their baseline fasting and post-prandial parameters, to identify predictors of response.
The human hepatic response to a meal has never been studied at the tissue level and the findings of this study are likely to generate important data and clarify some of the fundamental questions regarding mechanisms of injury and insulin resistance. Furthermore, our study aims at identifying predictors of response to GLP-1RA and allow for appropriate selection of subjects for this class of medications, as well as to shed light on mechanism of response.
- Being tested
- Semaglutide
- Keywords
- Non-Alcoholic Steatohepatitis (NASH), Steatosis, Caloric Load
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Semaglutide injection once weekly
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Steatosis | Experimental | Participants with steatosis on baseline biopsy Receives: Drug: Semaglutide |
| Arm B: NASH | Experimental | Participants with NASH on baseline biopsy Receives: Drug: Semaglutide |
| Arm C: Healthy | No intervention | Healthy Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Improvement
>= point decrease in NAFLD activity score (range 0-8, high scores indicate more activity)
Measured: 30 weeks
Clinical Improvement
Reduction of liver fat content (measure with 1H-magnetic resonance spectroscopy) by >= 25% and reduction of ALT by >=25% or normalization of ALT
Measured: 30 weeks
Change in hepatic gene expression
Change in hepatic gene expression for biopsies performed at baseline and 2 hours after an oral 75g glucose load
Measured: 2 hours after an oral 75g glucose load
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start24 Jul 2019
- Primary completion31 Aug 2028 (estimated)
- Study completion2 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yaron Rotman, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884075
- Sponsor's protocol ID
- 190072
- Other IDs
- 19-DK-0072
- Status last verified
- 23 Oct 2026
- First submitted
- 20 Mar 2019
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I will share human data generated in this research for future research as follows (check all that apply): @@@@@@@@@@@@\_X\_ De-identified data in an NIH-funded or approved public repository
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
- Non-Alcoholic Fatty Liver Disease, the Hepatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
- ClinicalTrials.gov ID
- NCT03884075
- Acronym / sponsor ID
- 190072
- Keywords
- Non-Alcoholic Steatohepatitis (NASH), Steatosis, Caloric Load
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 2 Oct 2028 (estimated)
- First posted
- 21 Mar 2019 (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.
Background:
In non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication can help.
Objective:
To find out how the liver in people with NAFLD responds to feeding, and how this relates to their response to the drug semaglutide.
Eligibility:
People with NAFLD and healthy volunteers ages 18 and older
Design:
Participants will be screened with:
Medical history
Physical exam
Blood tests
Imaging: A machine will take pictures of the participant s body.
Within 2-8 weeks of enrollment, participants will stay in the clinic for several days. This includes:
Blood, urine, heart, and imaging tests
For NAFLD participants only: A needle-like device will remove a small biopsy of the liver and fatty tissue.
Participants will be alone in a special room for 5 hours. They will breathe through a tube under the nostrils. They will have blood drawn several times.
The baseline visit concludes participation for healthy volunteers but NAFLD participants will contine.
About 6 weeks after discharge, participants will stay in the clinic again and repeat the tests. They will get their first semaglutide dose by injection.
Participants will have visits weeks 1, 2, 4, 8, 12, 16, 20, and 24 of treatment. Visits include blood tests.
Participants will inject semaglutide once a week at home.
At week 30, participants will stay in the clinic again and repeat the tests.
Participants will have a final visit 12 weeks after stopping treatment. This includes blood and urine tests.
...
Detailed description
Non-alcoholic fatty liver disease (NAFLD) and its progressive form, non-alcoholic steatohepatitis (NASH), are leading causes of liver injury and are tightly associated with obesity, diabetes and the metabolic syndrome. Despite recent advances, there is still a considerable knowledge gap regarding the fundamental pathogenic mechanisms, and especially regarding the transition from benign steatosis to steatohepatitis. Although NAFLD reflects disordered energy metabolism in the liver, little information exists on the response of the human liver to the acute caloric load of a meal. We hypothesize, based on preliminary non-invasive results, that in patients with NAFLD, an oral carbohydrate load results in preferential de novo lipogenesis (due to selective insulin resistance) and generation of fatty acids (FA). We further hypothesize a spillover effect, wherein NASH patients have an impairment of the hepatic ability to esterify the load of FA to triglycerides (TG) compared to patients with steatosis, resulting in accumulation of lipotoxic intermediary metabolites.
GLP-1 receptor agonists (GLP-1RA) have demonstrated significant benefit in the treatment of diabetes and obesity. Liraglutide was shown in a prospective trial to improve NASH histology and other GLP-1RA have shown benefit in secondary analyses, consistent with a class effect. However, response rates to GLP-1RA, as well as to other pharmacological interventions in NAFLD, have not exceeded 50%, and there are no adequate baseline predictors of response that could allow for selection of subjects for personalized treatment. Given that GLP-1RAs exert their main activity in the post-prandial state, it is plausible that post-prandial parameters may be more effective in predicting treatment response and can shed light on its mechanism.
Our aims in this study are (1) to assess the hepatic response to an acute oral carbohydrate load; (2) to identify which baseline parameters can predict the clinical response of NAFLD patients to a course of semaglutide, a novel GLP-1RA.
We propose a non-randomized, single-center, pilot exploratory study in which 32 subjects with steatosis (12-20) or NASH (12-20) will initially undergo two liver biopsies, one in the fasting state and one performed 2 hours after an oral 75g glucose load (OGTT biopsy). Tissue samples obtained will be subjected to a comparative, paired analysis of gene expression, protein phosphorylation in key signaling pathways, composition of tissue lipid species and oxidative stress. Subjects will be treated with semaglutide (escalated to 1 mg/week) for 30 weeks in all subjects, and their clinical response will be assessed by ALT and 1H-Magnetic resonance spectroscopy and a final (3rd) liver biopsy. Clinical responders will be compared to non-responders with regards to their baseline fasting and post-prandial parameters, to identify predictors of response.
The human hepatic response to a meal has never been studied at the tissue level and the findings of this study are likely to generate important data and clarify some of the fundamental questions regarding mechanisms of injury and insulin resistance. Furthermore, our study aims at identifying predictors of response to GLP-1RA and allow for appropriate selection of subjects for this class of medications, as well as to shed light on mechanism of response.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Steatosis | Experimental | Drug: SemaglutideParticipants with steatosis on baseline biopsy |
| Arm B: NASH | Experimental | Drug: SemaglutideParticipants with NASH on baseline biopsy |
| Arm C: Healthy | No intervention | –Healthy Volunteers |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Additional Inclusion Criteria for Treatment Phase
- Presence of NAFLD (steatosis grade greater than or equal to 1 on NASH-CRN scoring scale) on baseline admission liver biopsy.
- Liver fat content greater than or equal to 10% by 1H-MRS on initial admission.
- Male or female Aged greater than or equal to 18 years of age.
- No evidence of hepatic steatosis by imaging or histology.
Key exclusion criteria (35 listed)
- Pregnant or breast-feeding
- Chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who were treated successfully for HCV and achieved sustained virological response can be eligible for enrollment > 18 months after treatment cessation. Patients receiving antiviral therapy are ineligible.
- HIV infection.
- Concomitant liver disease such as autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson s disease, alpha-1 antitrypsin deficiency, hereditary hemochromatosis.
- Presence of definite or probable drug-induced liver injury. In the case of lipid-lowering, anti-hypertensive or anti-diabetic medications that are suspected to cause aminotransferase elevation, patients will be eligible if treatment is associated with stable enzyme levels for at least 6 months.
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 |
|---|---|---|
| SemaglutideSemaglutide injection once weekly | Drug | Arm A: Steatosis, Arm B: NASH |
Primary outcome
Histological Improvement
Time frame: 30 weeks
>= point decrease in NAFLD activity score (range 0-8, high scores indicate more activity)
Clinical Improvement
Time frame: 30 weeks
Reduction of liver fat content (measure with 1H-magnetic resonance spectroscopy) by >= 25% and reduction of ALT by >=25% or normalization of ALT
Change in hepatic gene expression
Time frame: 2 hours after an oral 75g glucose load
Change in hepatic gene expression for biopsies performed at baseline and 2 hours after an oral 75g glucose load
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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. I will share human data generated in this research for future research as follows (check all that apply): @@@@@@@@@@@@_X_ De-identified data in an NIH-funded or approved public repository
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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.
Yaron Rotman, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide in people with Non-Alcoholic Steatohepatitis and Non-Alcoholic Fatty Liver Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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 16 inclusion and 35 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: looking for participants now, 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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yaron Rotman, M.D. ((301) 451-6553, rotmanyaron@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological Improvement (time frame: 30 weeks). The study lists 3 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; AzTrials last refreshed its copy on 8 Nov 2026.