[Results] 28 weeks on 10mg, full numbers, ask me anything boring
28 weeks on 10mg, full numbers, ask me anything boring. This is a description of what happened to me and not a plan for anybody else.
Numbers, in the order they matter: 28 weeks and 10mg.
Phase 2 in a biopsy-confirmed population is a demanding design: recruitment is slow, the population is specific, and the results do not generalise to people who have not been characterised that way.
Imaging-derived liver fat fraction is a surrogate. It correlates with histology imperfectly, and a trial reporting one is not reporting the other.
Ask me anything specific. Anything general I will probably get wrong.
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.
Removed the escalation schedule. Unapproved compound, no protocols for other members, no exceptions.
That is an escalation schedule for an unapproved compound and this board does not host those.
Right, and the trial titration was slow for reasons that are visible in the tolerability tables.
Right, and the trial titration was slow for reasons that are visible in the tolerability tables.
Agreed — and the endpoint definitions are where the actual claim lives.
Agreed — and the endpoint definitions are where the actual claim lives.
Adding the standing caveat — unapproved compound, research material is not for human use.
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.
The escalation schedules in the published protocols are slow and deliberate, and the tolerability tables show why. That is a description of the trials rather than a suggestion for anybody.
Correction: that is the imaging endpoint, not the histological one. The paper reports both and they differ substantially.
Yes — nothing containing this is approved anywhere, which is the first fact and usually the last one mentioned.
The escalation schedules in the published protocols are slow and deliberate, and the tolerability tables show why.
certified_reference is right that biopsy and imaging endpoints are not interchangeable.
Same. Very thin independent data on this one, which should make everybody here more tentative than they are.
How fast was the escalation in that protocol?
Biopsy-confirmed population or imaging-selected?
Which phase and which arm are you quoting?
Which phase and which arm are you quoting?
This is the framing the board needs. It is a hepatic programme first.
Small fix — dual agonist, GLP-1 and glucagon. No GIP arm in this molecule.
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independent testing on this compound is very thin
research material is not approved for human use, which is why the clinical record here is thin
Agreed that the endpoint definitions matter enormously and almost nobody reads them before quoting a response rate.
Are you reading the publication or a summary?
Are you reading the publication or a summary?
Disagreeing with this bit: that number comes from a different programme with a different population.
MASH endpoints are histological, which is a much harder bar
phase 2 in liver disease is a different evidence question from weight
the hepatic data is what makes this compound different from the others
this board is small because the compound is early
fibrosis improvement without worsening steatohepatitis is the phrase to learn
Which endpoint — histological response, fibrosis improvement, or fat fraction?
This. Biopsy-confirmed and imaging-suggested are different evidentiary categories and get run together constantly.
- 1How fast was the escalation in that protocol?9 comments in this branch · started by u/border_paperwork