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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06005012
Phase
PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
40 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    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).
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
Jul 25, 2023
Status verified
Sep 2023
Primary completion
Mar 31, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
    2.4 mg weekly for 52 weekly in a 3 ml PDS290 pen-injector containing Semaglutide 3.0 mg/ml for subcutaneous use
  • Placebo Comparator: Placebo
    2.4 mg weekly for 52 weekly in a 3 ml PDS290 pen-injector containing 3.0 mg/ml of a placebo solution for subcutaneous use

Primary Outcome Measure

Change in fibrosis due to NAFLD [ Time Frame: 52 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093
Egbert Madamba
[email protected]
858-246-2227

Find similar trials in La Jolla, CA

By research site
University of California, San Diego· La Jolla, CA

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