Impact of Semaglutide in Liver Transplant Candidates with Obesity (SOMAL Study): A Prospective Randomized Study.

Conditions

Arterial hypertension, Type 2 diabetes mellitus, Obesity, Dyslipidaemia

Brief summary

Percentage change in body weight from the start of treatment to the time of liver transplant, comparing semaglutide with standard treatment.

Detailed description

Total change in body weight from the start of treatment to the transplant., Proportion of patients achieving a weight loss of ≥5%, ≥10% and ≥15% of body weight., Change in BMI., Changes in body composition: Visceral fat mass. Skeletal muscle mass (muscle index at L3 as measured by CT or DXA). Diagnosis of sarcopenia. Changes in metabolic parameters: Fasting glucose, HbA1c, HOMA-IR, total cholesterol, LDL, HDL, triglycerides., Incidence of Early Graft Dysfunction (DPI/EAD) according to Olthoff’s criteria., Incidence of major complications (Clavien-Dindo ≥ IIIa) during the first 90 days., Length of stay in the ICU., Total length of hospital stay., Incidence of reoperation., Incidence of readmission to hospital within 90 days., Incidence of adverse events associated with semaglutide., Incidence of adverse events and serious adverse events., Discontinuation of treatment due to toxicity., Incidence of perioperative major adverse cardiovascular events (cardiovascular death, myocardial infarction or stroke).

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Interventions

DRUGWegovy 1 mg FlexTouch solution for injection in pre-filled pen

DRUGWegovy 0.5 mg FlexTouch solution for injection in pre-filled pen

DRUGWegovy 2.4 mg FlexTouch solution for injection in pre-filled pen

DRUGWegovy 0.25 mg FlexTouch solution for injection in pre-filled pen

DRUGWegovy 1.7 mg FlexTouch solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage change in body weight from the start of treatment to the time of liver transplant, comparing semaglutide with standard treatment.	—

Secondary

Measure	Time frame
Total change in body weight from the start of treatment to the transplant., Proportion of patients achieving a weight loss of ≥5%, ≥10% and ≥15% of body weight., Change in BMI., Changes in body composition: Visceral fat mass. Skeletal muscle mass (muscle index at L3 as measured by CT or DXA). Diagnosis of sarcopenia. Changes in metabolic parameters: Fasting glucose, HbA1c, HOMA-IR, total cholesterol, LDL, HDL, triglycerides., Incidence of Early Graft Dysfunction (DPI/EAD) according to Olthoff’s criteria., Incidence of major complications (Clavien-Dindo ≥ IIIa) during the first 90 days., Length of stay in the ICU., Total length of hospital stay., Incidence of reoperation., Incidence of readmission to hospital within 90 days., Incidence of adverse events associated with semaglutide., Incidence of adverse events and serious adverse events., Discontinuation of treatment due to toxicity., Incidence of perioperative major adverse cardiovascular events (cardiovascular death, myocardial infarc	—

Measure

Time frame

Total change in body weight from the start of treatment to the transplant., Proportion of patients achieving a weight loss of ≥5%, ≥10% and ≥15% of body weight., Change in BMI., Changes in body composition: Visceral fat mass. Skeletal muscle mass (muscle index at L3 as measured by CT or DXA). Diagnosis of sarcopenia. Changes in metabolic parameters: Fasting glucose, HbA1c, HOMA-IR, total cholesterol, LDL, HDL, triglycerides., Incidence of Early Graft Dysfunction (DPI/EAD) according to Olthoff’s criteria., Incidence of major complications (Clavien-Dindo ≥ IIIa) during the first 90 days., Length of stay in the ICU., Total length of hospital stay., Incidence of reoperation., Incidence of readmission to hospital within 90 days., Incidence of adverse events associated with semaglutide., Incidence of adverse events and serious adverse events., Discontinuation of treatment due to toxicity., Incidence of perioperative major adverse cardiovascular events (cardiovascular death, myocardial infarc

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Outcome results

None listed