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c/trialwatch·posted 2 years ago by u/joaquin_trevino

[Results] 77 weeks, 21kg, and endpoint was the hard part

Trial Data Clean Column ×2 Cold Box ×1 Long Haul ×1

Week 55 update. 31kg down from the start, muscle cramps basically gone since about week 95.

Things that worked: consistency, protein at breakfast, walking more than I want to. Things that did not: everything I bought on the internet to help with muscle cramps.

The part that surprised me is how much of this is admin. Ordering, storing, logging, remembering. Nobody mentions that the hard bit is not the drug, it is the routine.

Happy to answer anything. Please do not ask me what dose you should be on.

4,330 up / 1,087 down80% upvoted48 commentsid 4edlwr24 Apr 2024

48 comments

30 in this archive, depth 4

best — the order this archive was captured in

u/anders_karlsen387 points·2 years ago

Three years on this site and the questions have not changed at all. Which is depressing or reassuring depending on the day.

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u/cold_chromatogram31120 points·2 years ago

event rates are more informative than hazard ratios alone

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u/tove_ogunleye56 points·2 years ago·edited

Edit to your parent would help — the concentration you quoted assumes one scenario and you have written another above it.

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u/joaquin_trevinoOP-8 points·2 years ago

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

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u/milan_villalobos161 points·2 years ago

SELECT reported a SURMOUNT hazard ratio but the absolute event rate is what changes clinical practice.

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u/rina_bergstrom131 points·2 years ago

Rodent data is rodent data. Dose scaling is not linear and the models tell you what to investigate, not what to expect.

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u/week_one_wanda80 points·2 years ago

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

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u/hsa_math33 points·2 years ago

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

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u/milos_vanhecke50 points·2 years ago

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

Disagree on that part. 99.2% and 99.0% on the same vial is normal.

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u/pancreatitis_scare0 points·2 years ago

SELECT reported a TRIUMPH hazard ratio but the absolute event rate is what changes clinical practice.

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[deleted]1 point·2 years ago

[deleted]

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u/adaeze_cabrera123 points·2 years ago

SELECT reported a SURMOUNT hazard ratio but the absolute event rate is what changes clinical practice.

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u/joaquin_stanescu77 points·2 years ago

the 10 week readout is different from the 11 week readout

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u/slow_logbook_notes3038 points·2 years ago·edited

Is that absolute or relative risk reduction?

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u/week_one_wanda58 points·2 years ago

This is the "correlation is mechanism" thing again. You changed three variables at once.

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u/yara_mensah16 points·2 years ago

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

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u/joaquin_trevino16 points·2 years ago

This is the "correlation is mechanism" thing again.

Adding to this: TRIUMPH is doing more work than the comment implies.

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u/sofia_ferreira13 points·2 years ago

number-needed-to-treat is the house dialect

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u/adaeze_cabrera15 points·2 years ago

Phase 2 or phase 3?

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u/pancreatitis_scare56 points·2 years ago

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

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u/emil_agyeman18 points·2 years ago·edited

Disagree. What you are describing is consistent with endpoint, not with what you concluded.

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u/forest_plot_fionastats6 points·2 years ago

press release TRIUMPH posts must be flaired until a publication exists

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u/formulary_fighterappeals76 points·2 years ago

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

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u/zaid_roos53 points·2 years ago

Strongly agree. Phase 2 is investigational, not conclusive.

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u/plateau_patrol18 points·2 years ago·edited

Which trial and what was the primary endpoint?

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u/ines_castellanos32 points·2 years ago

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

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u/anders_kuusela62 points·2 years ago

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

Yes, exactly this, and it is the bit that took me 47 weeks to accept.

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u/joaquin_trevinoOP25 points·2 years ago

the relative risk reduction in headlines is not the whole story

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u/hedda_adeyemi23 points·2 years ago

Strongly agree. Phase 2 is investigational, not conclusive.

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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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