Plain-English translation of NCT07058155 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 4 — The treatment has already been approved. Researchers are tracking how it works in a large number of people over time.
The OPTIMAL Trial is testing a two-step treatment approach for people who have advanced liver disease, obesity, and high pressure in their liver blood vessels. Some participants will receive a procedure called a transjugular intrahepatic portosystemic shunt (TIPS) to reduce pressure in those vessels, then have weight loss surgery a few weeks later. Others will follow a medical weight loss program with counseling and medication instead.
Obesity makes liver disease worse and increases the risk of complications, but weight loss surgery can be dangerous for people with advanced liver disease because of the high pressure in their liver blood vessels. Small studies suggest that placing a shunt first to reduce this pressure might make surgery safer and more effective, but doctors need to test this idea in a proper research trial.
You likely qualify if…
You likely don't qualify if…
If you are randomly selected for the surgery group, you will first undergo a procedure to place the shunt in your liver blood vessels, then wait 4 to 6 weeks for your body to adjust. After that, you will have weight loss surgery (sleeve gastrectomy) and receive follow-up care and lifestyle counseling. If you are in the medical management group, you will work with doctors on a personalized weight loss plan using diet, exercise, behavior changes, and anti-obesity medications. The trial is based at Cleveland Clinic.
AI-generated summary from trial data · Jun 19, 2026 · Not medical advice
United States