TIRZEPATIDE for Obesity

Inclusion criteria

• {"criterion_text":"- Liver transplant candidate undergoing pre-transplant evaluation (inpatient or outpatient) at the Department of Hepatogastroenterology, aged ≥18 years."}
• {"criterion_text":"- BMI ≥ 30, or BMI ≥ 33 in case of significant fluid retention (edema of lower extremities, ascites, hydrothorax; for large ascites/hydrothorax, BMI will be evaluated after evacuation puncture)."}
• {"criterion_text":"- Clinically stable (patient is at home under outpatient follow-up or hospitalized on a standard ward without clinical or laboratory signs of significant deterioration or complications)."}
• {"criterion_text":"- Signed informed consent."}

Exclusion criteria

• {"criterion_text":"- Hepatic encephalopathy"}
• {"criterion_text":"- Refractory ascites/hydrothorax (≥2 evacuation procedures in the last 2 months)."}
• {"criterion_text":"- Combined liver-kidney transplantation."}
• {"criterion_text":"- Pregnancy (pre-enrollment assessment includes a pregnancy test; women of childbearing potential must agree to use highly effective contraception — hormonal or barrier methods, or abstinence; highly effective methods are defined as those with failure rate <1% per year with correct and consistent use)."}
• {"criterion_text":"- History of acute or chronic pancreatitis."}
• {"criterion_text":"- Polycystic liver disease"}
• {"criterion_text":"- Type 1 diabetes mellitus"}
• {"criterion_text":"- Liver malignancy outside Milan criteria (Milan-out, Klatskin tumor, colorectal carcinoma metastases, NET metastases)."}
• {"criterion_text":"- Unstable clinical condition or unplanned hospitalization due to significant deterioration or complication."}
• {"criterion_text":"- Spontaneous weight loss (≥5% in the past 6 months, not due to diuretic or evacuation treatment)."}
• {"criterion_text":"- Sarcopenia according to pre-transplant CT."}
• {"criterion_text":"- Inability to perform physical activity (walking 30 min/day)."}

Primary endpoints

• {"endpoint_text":"- Absolute and relative change in body weight/BMI/body fat composition during the follow-up period.","definition_or_measurement_approach":"Change in body weight, BMI and body fat composition measured during the follow-up period (exact measurement schedule not specified in provided data)."}

Secondary endpoints

• {"endpoint_text":"- Occurrence of complications while on the waiting list (WL) related to the underlying liver disease","definition_or_measurement_approach":"Occurrence of complications on the transplant waiting list (no further measurement details provided)."}
• {"endpoint_text":"- Safety of treatment (adverse events)","definition_or_measurement_approach":"Recording of adverse events to assess safety (no grading or specific AE collection approach provided)."}
• {"endpoint_text":"- Post-transplant complications (1M, 3M, 6M)","definition_or_measurement_approach":"Incidence of post-transplant complications assessed at 1 month, 3 months and 6 months post-transplant."}
• {"endpoint_text":"- Patient survival (1M, 3M, 6M)","definition_or_measurement_approach":"Patient survival measured at 1 month, 3 months and 6 months."}
• {"endpoint_text":"- Graft survival (1M, 3M, 6M)","definition_or_measurement_approach":"Graft survival measured at 1 month, 3 months and 6 months."}

Czechia

Earliest CTIS Part Ii Submission Date

16-03-2026

Latest Decision Or Authorization Date

18-03-2026

Processing Time Days

2

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Institute For Clinical And Experimental Medicine

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia

Third parties

• {"country":"","full_name":"institut klinické a experimentální medicíny","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Agentura pro zdravotnický výzkum České republiky","duties_or_roles":"Monetary support","organisation_type":""}