Semaglutide 2·4 mg once weekly in patients with non-alcoholic steatohepatitis-related cirrhosis : a randomised, placebo-controlled phase 2 trial
Loomba, Rohit Abdelmalek, Manal F Armstrong, Matthew J Jara, Maximilian Kjær, Mette Skalshøi Krarup, Niels Lawitz, Eric Ratziu, Vlad Sanyal, Arun J Schattenberg, Jörn M
Loomba, Rohit
Abdelmalek, Manal F
Armstrong, Matthew J
Jara, Maximilian
Kjær, Mette Skalshøi
Krarup, Niels
Lawitz, Eric
Ratziu, Vlad
Sanyal, Arun J
Schattenberg, Jörn M
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2023-03-16
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Abstract
This double-blind, placebo-controlled phase 2 trial enrolled patients from 38 centres in Europe and the USA. Adults with biopsy-confirmed NASH-related cirrhosis and body-mass index (BMI) of 27 kg/m2 or more were randomly assigned (2:1) to receive either once-weekly subcutaneous semaglutide 2·4 mg or visually matching placebo. Patients were randomly allocated via an interactive web response system, stratified by presence or absence of type 2 diabetes. Patients, investigators, and those assessing outcomes were masked to treatment assignment. The primary endpoint was the proportion of patients with an improvement in liver fibrosis of one stage or more without worsening of NASH after 48 weeks, assessed by biopsy in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study drug. The trial is closed and completed, and registered with ClinicalTrials.gov, number NCT03987451.
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Lancet Gastroenterol Hepatol. 2023 Jun;8(6):511-522. doi: 10.1016/S2468-1253(23)00068-7.
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Article