why does nobody talk about biopsy
Slightly embarrassed to be asking this, but: why does nobody talk about biopsy.
Bought small because the evidence base is early. That is the only defensible position I could construct.
The honest evidence position, written out so this board does not drift.
Phase 2 data exists in a specific, biopsy-characterised population, with a slow protocol escalation and tolerability tables worth reading in full. Nothing containing this compound is approved by any regulator anywhere. Research-use-only material is not approved for human use.
Independent purity results across this entire site number in the low single figures. That means nobody here — including the people who post most confidently — has a basis for statements about batch-to-batch consistency. If you test something, post it; the log is the only thing that will change that position.
The endpoint vocabulary, because you cannot read this literature without it.
Resolution of steatohepatitis without worsening of fibrosis and improvement in fibrosis without worsening of steatohepatitis are the two standard composite endpoints, both scored on biopsy by pathologists against a defined system. Liver fat fraction is an imaging surrogate that correlates imperfectly with histology.
A trial can move the surrogate substantially and the histological endpoint modestly. Both results are real; they answer different questions. Anybody quoting a response rate here should say which endpoint it refers to, and most summaries do not.
If somebody has the same thing measured a different way, post it next to mine and we will see whether they agree.
best — the order this archive was captured in
Histological endpoints in this field are scored on biopsy: resolution of steatohepatitis without worsening of fibrosis, or improvement in fibrosis without worsening of steatohepatitis. Both are harder to achieve and to interpret than an imaging surrogate.
It is a dual agonist at the GLP-1 and glucagon receptors. The glucagon arm is associated with increased energy expenditure and with effects on hepatic fat, which is why the development programme is oriented towards liver disease.
Which endpoint — histological response, fibrosis improvement, or fat fraction?
Went slowly because everything published describes a deliberate escalation. That is the extent of what I will say about it.
the hepatic data is what makes this compound different from the others
Which phase and which arm are you quoting?
Is that a weight number from a different programme?
Agreed that the endpoint definitions matter enormously and almost nobody reads them before quoting a response rate.
MASH endpoints are histological, which is a much harder bar
this board is small because the compound is early
This. Biopsy-confirmed and imaging-suggested are different evidentiary categories and get run together constantly.
Right, and the trial titration was slow for reasons that are visible in the tolerability tables.
- 1Histological endpoints in this field are scored on biopsy: resolution of…6 comments in this branch · started by u/nadia_kjaer
- 2Is that a weight number from a different programme?6 comments in this branch · started by u/santiago_villalobos