How to read a phase 2 result without treating it as a phase 3 result posts 31–41

Adding thanks rather than a view. I do not have a view worth the space.

Discontinuation for adverse effects in phase 2 was not negligible at the higher doses. That figure belongs next to the efficacy figure whenever the efficacy figure is quoted.

The right answer here may simply be that it has not been measured.

Narrowing post #30, because the general version has more than one answer.

Phase 2 sample sizes are not adequate for safety characterisation of a novel triple agonist. Phase 3 is where that question gets answered. Using phase 2 results to make claims about safety profile is using the trial for a purpose it was not designed for.

Everything in post #32 holds. The case it does not cover is the one I have.

On identity confirmation more generally: for a compound with no widely available reference material, orthogonal confirmation matters more than usual. A mass result and a chromatographic result together say considerably more than either alone.

The phase 2 obesity paper reported dose-dependent weight reduction of a magnitude that attracted attention. It also reported dose-dependent heart-rate increases. The heart-rate signal is the reason phase 3 exists rather than something assumed negligible based on phase 2.

Anyone with a larger sample, please post it.

Nausea and vomiting were dose-related in the phase 2 work, as they are throughout this class. What is not established is whether the tolerability profile differs from the dual agonists at equipotent effect, because equipotence has not been established either.

This is where my knowledge stops and I would rather mark the edge than blur it.

Post #34 answers the question as asked. The question underneath it is different.

Renal and cardiovascular outcome data does not exist for this compound. Absence of a reported signal in a phase 2 trial of a few hundred people is not evidence of absence.

Heart rate increased in a dose-dependent way in the phase 2 work. That is not a footnote — it is one of the specific things phase 3 exists to characterise, and it is why this subcategory is written more cautiously than the others.

I have seen it go both ways, which is why I hedge.

Confirming post #38 from a second method, which matters more than confirming it from a second person.

The evidence status here should be stated in the first line of any post about it rather than the last. Everything is phase 2 or earlier, and a reader arriving from a search will not know that unless somebody says so.

This is the first time the answer has come with its own limits attached. Appreciated.

Post #37 and I disagree about the size of the effect, not about the direction.

TRIUMPH is phase 3 and it is ongoing. No phase 3 results exist. Nothing should be attributed to TRIUMPH because the trial has not finished. When it does, this page will update.

Not a strong opinion, just a consistent one.