Summary

Eligibility
for people ages 40-79 (full criteria)
Location
at La Jolla, California
Dates
study started
completion around
Principal Investigator
by Rohit Loomba
Headshot of Rohit Loomba
Rohit Loomba

Description

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.

Details

Nonalcoholic fatty liver disease (NAFLD) affects approximately 25-30% of the global population and is projected to become the leading cause of liver transplantation in the United States by 2030. Development of efficient screening strategies for the identification and treatment of individuals who are at greatest risk for advanced disease in this population is an urgent and unmet medical need. Type 2 diabetes mellitus (T2DM) and obesity are critical risk factors for advanced NAFLD. In a prospective cross-sectional study of patients with type 2 diabetes, we screened 524 participants (50-80 years old) with type 2 diabetes mellitus for the presence of NAFLD and observed relative prevalences of 70% for steatosis and 15% for advanced fibrosis. The presence of obesity in this population further increased the odds of advanced fibrosis. These findings suggest that screening populations of individuals with obesity or T2DM may be an effective strategy for identifying high-risk patients with NAFLD. Semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA) that is FDA-approved for the treatment of obesity (as Wegovy) or T2DM (as Ozempic), conditions that are considered major risk factors for advanced fibrosis in the NAFLD population. It is unclear, however, whether semaglutide is effective for treatment of fibrosis due to NAFLD in these populations. Here, the investigators propose to 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.

Keywords

Fibrosis, Liver, Type 2 Diabetes Mellitus in Obese, Non-Alcoholic Fatty Liver Disease, Liver Diseases, Fatty Liver, Liver Cirrhosis, Type 2 Diabetes Mellitus, Fibrosis, Semaglutide

Eligibility

Location

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States

Lead Scientist at UCSD

  • Rohit Loomba
    Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 285 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06005012
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated