Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM (NCT06005012) | Clinical Trial Compass
UnknownPhase 2
Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM
United States120 participantsStarted 2023-07-25
Plain-language summary
Conduct a community intervention study that will 1) validate a screening approach to identify patients at risk for advanced NAFLD in the obese or T2DM population, and 2) test whether semaglutide treatment is effective for the management of significant fibrosis due to NAFLD in high-risk patients.
Who can participate
Age range40 Years – 79 Years
SexALL
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Inclusion criteria
✓. Adult, age ≥ 40 and \< 80 years
✓. Participant must meet at least one of following sets of conditions:
✓. BMI ≥ 27 kg/m² OR
✓. BMI ≥ 25 kg/m² AND presence of i) pre-diabetes (HbA1C ≥ 5.7) or ii) type 2 diabetes mellitus (T2DM), as defined by the American Diabetes Association (ADA) clinical practice recommendations.
✓. FAST score ≥ 0.5 and VCTE ≥ 8.0 kPa; FAST score threshold based on data from MAESTRO-NASH trial⁴²; VCTE cutpoint based on AASLD guidelines for identification of patients with significant fibrosis risk.
✓. Participants without a VCTE assessment in their medical record may qualify for the study if they have a FIB-4 ≥ 1.0, which is a cutpoint based on observations of patients with T2DM in Ajmera et al³⁰, and VCTE ≥ 8.0 kPa.
✓. The subject is fully informed and willing and able to perform all the procedures specified in the protocol and has signed a written informed consent to participate
Exclusion criteria
✕. Presence of regular and/or excessive use of alcohol, defined as \> 30 g/day for males and \> 20 g/day for females, for a period longer than 2 years at any time in the last 10 years
✕. Evidence of cirrhosis or previously known cirrhosis, based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices