Hepatic impairment and the absence of data — a second dataset

On the subject in the title: Hepatic impairment and the absence of data — a second dataset Working notes rather than a conclusion.

Asking about a population rather than about a person.

The published trials in this class mostly enrolled a fairly specific group, and the questions here frequently come from people well outside it. I would like to understand what the honest position is when someone falls outside the studied population: not "it is fine" and not "there is no data", but what the reasoning actually looks like.

I read the opening post twice before replying, because I had assumed the opposite.

Gastroparesis: pre-existing severe delayed gastric emptying can worsen with compounds that slow it further. Discussion with a clinician is prudent if this history exists.

Pancreatitis history: the compounds can rarely trigger pancreatitis. A history of pancreatitis makes monitoring for recurrence more important during titration.