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Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM

NCT06005012 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-09-07

No results posted yet for this study

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.

Conditions

  • Fibrosis, Liver
  • Type 2 Diabetes Mellitus in Obese
  • Non-Alcoholic Fatty Liver Disease

Interventions

DRUG

Semaglutide

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).

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Rohit Loomba · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-25
Primary Completion
2025-03-31
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06005012 on ClinicalTrials.gov