Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Anti-Obesity Pharmacotherapy (Class Effect) for Liver Cirrhoses

Cirrhosis is a form of advanced liver disease that can lead to serious complications, especially when combined with severe obesity. Many patients with cirrhosis also develop a condition called clinically significant portal hypertension (CSPH), which is increased pressure in the veins of the liver.

Official registry: https://clinicaltrials.gov/study/NCT07058155 · The Cleveland Clinic · enrollment listed as 70

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Transjugular Intrahepatic Portosystemic Shunt (TIPS), Sleeve Gastrectomy, or Anti-Obesity Pharmacotherapy (Class Effect). The registry lists allocation as randomized. Cirrhosis is a form of advanced liver disease that can lead to serious complications, especially when combined with severe obesity.

They plan to enroll about 70 people at Cleveland. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app), a procedure as part of the study plus check-ins.

Official title (unrewritten)

OPTIMAL Trial: Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease

Interventions: Transjugular Intrahepatic Portosystemic Shunt (TIPS), Sleeve Gastrectomy, Anti-Obesity Pharmacotherapy (Class Effect), Lifestyle Counseling - Diet & Physical-Activity Program

Primary outcome (registry wording): Change in SF-36 Physical Component Summary (PCS) Score From Baseline to 6 Months

Who it is for (from inclusion criteria)

  • Ages 18 Years to 70 Years
  • Is a candidate for general anesthesia
  • Has a body-mass index (BMI) ≥35 and ≤85 kg/m2 at the time of first study visit
  • Is eligible for metabolic surgery (SG) based on the ASMBS/IFSO 2022 guidelines \[39\]
  • Has insurance coverage for metabolic surgery
  • Patients who are currently receiving or have previously received anti-obesity medicines will be considered for participation
  • Liver cirrhosis as determined via liver biopsy or noninvasive liver disease assessment
  • Has a negative urine pregnancy test at the first visit and at the randomization visits for women of childbearing potential

Public study contact (from the registry)

Ghazal F Daftari, MD

857-498-0045

daftarg@ccf.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07058155 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07058155?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07058155?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary