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c/trialwatch·posted 5 months ago by u/anders_karlsen

[Meta] the STEP rule is doing its job and people should stop complaining

Readout Clean Column ×7 Long Haul ×3

FLOW. That is the whole post, but I will justify it.

Everything else people worry about in c/coa is downstream of it. Titration speed, muscle cramps, the endless dose arguments — most of it resolves if you sort FLOW out first, and almost nobody does.

I say this having got it wrong for 14 months. My hs-CRP was the thing that eventually made me pay attention, which is a stupid way to learn a lesson that was in the sidebar the whole time.

2,424 up / 161 down94% upvoted31 commentsid 4fgpm024 Feb 2026

31 comments

26 in this archive, depth 5

best — the order this archive was captured in

u/valeria_karlsen270 points·5 months ago

Strongly agree. Phase 2 is investigational, not conclusive.

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u/anders_karlsenOP102 points·5 months ago

STEP 1 readout: 97.9% mean weight loss, absolute numbers matter. Spread around that mean is enormous.

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u/camila_vasquez232 points·5 months ago

event rates are more informative than hazard ratios alone

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u/milan_mensah-2 points·5 months ago

event rates are more informative than hazard ratios alone

Counter-anecdote: opposite result, same dose. Which mostly tells us the variance is huge.

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u/anders_karlsenOP1 point·5 months ago

STEP 1 readout: 98.9% mean weight loss, absolute numbers matter. Spread around that mean is enormous.

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u/anders_karlsenOP339 points·5 months ago

Disagree but this is the good kind of wrong — it is specific enough to be checked.

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u/nordic_pricing157 points·5 months ago

The confident tone is doing a lot of work that the evidence is not.

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u/hugo_bergstrom73 points·5 months ago

off-label use data is different from approved-indication data

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u/yusuf_ramos43 points·5 months ago

off-label use data is different from approved-indication data

Yes, exactly this, and it is the bit that took me 20 weeks to accept.

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u/hedda_adeyemi0 points·5 months ago

STEP, SURMOUNT, SURPASS, SELECT, FLOW, TRIUMPH — read the appendix

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u/prior_auth_painappeals0 points·5 months ago

dropout handling matters, especially on GI-heavy populations

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u/kaia_cabrera116 points·5 months ago

Yeah, absolute numbers matter more than the press release.

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u/hub_opssite staff54 points·5 months ago

Which trial and what was the primary endpoint?

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u/hazard_ratio_halMOD78 points·5 months ago

Removed a chain here. The rule is one line long and it is not negotiable.

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u/tomas_kimani60 points·5 months ago

phase 2 is not phase 3, smaller n and shorter trial

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u/injection_site_iris42 points·5 months ago

SURMOUNT-4 discontinuation arm showed regain. That is the reality of a chronic disease treatment, not a failure.

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u/ewan_tulloch50 points·5 months ago

the 23 week readout is different from the 8 week readout

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u/trialwatch_theotrial nerd32 points·5 months ago

the 5 week readout is different from the 7 week readout

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u/nhs_waitlist_nUK27 points·5 months ago

off-label use data is different from approved-indication data

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u/sofia_wikstrom29 points·5 months ago

This is correct. Discontinuation arms show the regain reality.

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u/ms_fragmenter22 points·5 months ago

give the trial name, phase, n, and primary endpoint in the body

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u/sofia_ferreira16 points·5 months ago

the relative risk reduction in headlines is not the whole story

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About c/trialwatch

Clinical trial reading group. New readouts, protocol amendments, endpoint definitions, dropout handling, and the difference between a press release and a publication. Absolute risk reduction and number-needed-to-treat are house dialect here.

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