Phase 2: testing Semaglutide for Non-Alcoholic Steatohepatitis
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.
Official registry: https://clinicaltrials.gov/study/NCT03884075 · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · enrollment listed as 104
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Semaglutide. The registry lists allocation as randomized. Background: In non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage.
They plan to enroll about 104 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Non-Alcoholic Fatty Liver Disease, the Hepatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
Interventions: Semaglutide
Primary outcome (registry wording): Histological Improvement
Who it is for (from inclusion criteria)
- Ages 18 Years to 100 Years
- 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
- Additional who can join 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
Who the registry excludes
- Pregnant or breast-feeding
- Concomitant liver disease such as autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson s disease, alpha-1 antitrypsin deficiency, hereditary hemochromatosis
- Treatment with medications known to cause fatty liver disease such as atypical neuroleptics, tetracycline, methotrexate or tamoxifen
- Uncontrolled hypo- or hyperthyroidism
- Congestive heart failure
- Chronic kidney disease, with creatinine clearance \< 60 ml/min or eGFR \< 60/ml/min/m(2)
- 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
Public study contact (from the registry)
Yaron Rotman, M.D.
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)
FAQ about this NCT record
Is NCT03884075 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT03884075?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT03884075?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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