On Friday, in its fourth-quarter 2023 earnings release, Inventiva SA (NASDAQ:IVA) said it has voluntarily paused screening and randomization of new patients in the NATiV3 Phase 3 trial of lanifibranor in non-alcoholic steatohepatitis (NASH).
The move follows the review of a reported treatment-related Suspected Unexpected Serious Adverse Reaction (SUSAR) of elevated aminotransferases (liver enzymes) in a patient enrolled in the trial.
This SUSAR is the first reported in all clinical trials with lanifibranor.
Before the voluntary pause, Inventiva was on track to complete screening by the end of the first quarter of 2024, …
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