Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingNot a traditional drug phaseobservationalRules rewrite
Evaluation of Non-Invasive Tests for Metabolic Liver Disease
The Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) study is a comprehensive, multi-year collaborative effort to standardize, validate and advance the regulatory qualification of blood- and imaging-based biomarkers to diagnose and stage Metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). MASH is characterized by liver inflammation accompanied by simultaneous fat accumulation in the liver.
This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.
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
This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.
They plan to enroll about 400 people at 4 sites. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) Study 2.0 - An FNIH Biomarkers Consortium Study
Primary outcome (registry wording): Detection of At-Risk MASH
Who it is for (from inclusion criteria)
Ages 18 Years to 75 Years
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged \> 18 years and \< 75 years
Participants must exhibit some manifestations of metabolic dysregulation. Either:
A. Physician-diagnosed T2DM for at least 90 days with HbA1c \> 6.5 and antidiabetic therapy, if any, stable for at least 90 days prior to screening or B. At least any one of the following six metabolic syndrome criteria \[6\]
Who the registry excludes
Current or past evidence of decompensated liver disease defined by overt ascites that is clinically obvious and requires diuretic therapy, overt encephalopathy requiring therapy or history of variceal hemorrhage
Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity. The more advanced form of this disease is known as nonalcoholic steatohepatitis (NASH).
Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is projected to be the leading cause of cirrhosis in the United States (U.S.) within the next few years. Women are at disproportionate risk for NASH, with approximately 15 million U.S.
This is a multi-center evaluation of efruxifermin (EFX) in a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
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 NCT07122700?
Not a traditional drug phase. 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 NCT07122700?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.