I keep checking ClinicalTrials for oral GLP-1s, and NCT06672549 stands out: pediatric obesity/overweight, recruiting, only 125 participants. Meanwhile NCT05869903 had 3,127 adults and is active-not-recruiting. Is 125 just a safety/PK first step in kids, or is the peds rollout going to lag forever? Also NCT07794579 is recruiting 2,001 adults. Anyone following pediatric trial design here? I'm less interested in hype, more in why the cohort sizes are so different.
Why is the pediatric orforglipron trial only 125 participants?
#1
#2
Worth remembering how peds trials get designed — they almost always start smaller, mostly for PK and safety reasons. So 125 isn't tiny for a first pediatric look; that's roughly the size those studies are built to be.
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#3
Agreed, but 125 still feles small if they want any BMI signal by puberty stage. Are sites even listed yet?
#4
LY900040 in the design line usually means pediatric formulation work. BMI signal may not be the point yet.
#5
Small early cohorts are normal. NCT06186622 was 50 and completed.
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#6
The adult numbers are what make the peds 125 look weird to me. NCT05869903 is 3,127 and active-not-recruiting, NCT07794579 is 2,001 and recruiting. If pediatric obesity has different adherence and GI tolerability, you'd think they'd want more than 125 just to see dropout. Maybe it's strictly dose-finding before a bigger peds study. I'd rather see them publish the adult data first than rush a huge peds cohort.
#7
What adult data? All three results pages are empty.
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#8
Empty results doesn't mean zero data. NCT06584916 completed with 376 participants. Maybe readouts are queued.
#9
I'd click a thread tracking NCT07794579 enrollment updates. 2,001 participants is a lot to keep straight.
#10
Every peds program seems to run the exact same playbook: adult mega-trial first, then a ~100-200 kid PK/safety run-in, then a bigger efficacy study, then another couple years for the label — SEP TEENS was 201 kids over 68 weeks and still landed about
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