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New treatment option for Liver Cirrhoses
Official title Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
ClinicalTrials.gov ID: NCT07058155
What this study is testing
What is Anti-Obesity Pharmacotherapy (Class Effect)?
Anti-Obesity Pharmacotherapy (Class Effect) is an investigational medicine, being studied as a potential treatment for liver cirrhoses.
Also referred to as GLP-1 receptor agonist, Topiramate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Candidate for general anesthesia.
- Age 18-70 years at consent.
- BMI 35-70 kg/m² at first study visit.
- Eligible for sleeve gastrectomy per ASMBS/IFSO 2022 guidelines.
- Insurance coverage for metabolic surgery.
You likely can't join if
- Prior bariatric/metabolic surgery (except removed devices ≥ 3 months earlier).
- Prior complex foregut surgery.
- History of solid-organ transplant.
- Severe pulmonary disease (FEV1 \< 50 % predicted).
- Significant cardiac or atherosclerotic disease with planned re-vascularization within 12 months.
- ASA class IV or V uncompensated cardiopulmonary disease.
See the full eligibility criteria
- Candidate for general anesthesia.
- Age 18-70 years at consent.
- BMI 35-70 kg/m² at first study visit.
- Eligible for sleeve gastrectomy per ASMBS/IFSO 2022 guidelines.
- Insurance coverage for metabolic surgery.
- Current or prior anti-obesity medication use permitted.
- Liver cirrhosis confirmed by biopsy or non-invasive assessment.
- Clinically significant portal hypertension (HVPG ≥ 10 mm Hg, or esophagogastric varices / portal-hypertensive gastropathy, or imaging evidence of collaterals/dilated portal vein).
- Able and willing to provide informed consent and comply with study procedures.
- Women of child-bearing potential: negative urine pregnancy test at screening and randomization and agreement to reliable contraception for 2 years.
- Prior bariatric/metabolic surgery (except removed devices ≥ 3 months earlier).
- Prior complex foregut surgery.
- History of solid-organ transplant.
- Severe pulmonary disease (FEV1 \< 50 % predicted).
- Significant cardiac or atherosclerotic disease with planned re-vascularization within 12 months.
- ASA class IV or V uncompensated cardiopulmonary disease.
- Left-ventricular ejection fraction \< 25 % or MI/unstable angina/stroke/heart surgery/coronary stent within 6 months.
- Hiatal hernia \> 7 cm or LA grade C/D erosive esophagitis.
- Active Crohn's disease.
- Severe psychiatric illness, dementia, active psychosis, history of suicide attempt, or alcohol/substance abuse within 12 months.
- Pregnant, breastfeeding, planning pregnancy, or not using adequate contraception.
- Malignancy within the prior 12 months (except non-melanoma skin cancer).
- Life expectancy \< 2 years in investigator's judgment.
- Investigational therapy within 3 months.
- Acute pancreatitis ≤ 90 days.
- Portal vein thrombosis at screening.
- Decompensated cirrhosis (moderate/large ascites, hepatic encephalopathy, or listed for liver transplant); small ascites or prior variceal bleed allowed.
- Total bilirubin \> 3 mg/dL, INR \> 1.7, or platelets \< 50 000/µL (within 1 month).
- Significant alcohol intake (\> 14 units/week women, \> 21 units/week men) within the prior 12 months.
- eGFR \< 45 mL/min/1.73 m² or on dialysis (within 1 month).
- AIDS.
- Unable to understand study or give consent.
- Plans to move more than 3 hours from Cleveland within 6 months.
- Previous randomization in this trial.
- Any condition that, in the investigator's opinion, places the subject at undue risk.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.