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GLP-1 Trial & Approval Tracker

All studies

STEP 4 trial results

Adults with overweight or obesity without diabetes who completed a 20-week semaglutide lead-in.

Wegovy injection
Phase
Phase 3
Follow-up
48 weeks
Randomised
803
Sponsor
Novo Nordisk
Publication
JAMA · 2021

Randomised withdrawal trial. Participants continued semaglutide or switched to placebo after the lead-in. Treatment-policy analysis.

Mean body weight change from week 20 to week 68
  • Continued semaglutide 2.4 mg−7.9%
  • Switched to placebo+6.9%
Mean body weight change from week 20 to week 68
Trial armResult
Continued semaglutide 2.4 mg−7.9%
Switched to placebo+6.9%
Participants who reported gastrointestinal events after randomisation
Trial armResult
Continued semaglutide 2.4 mg41.9%
Switched to placebo26.1%

Safety. Adverse events led 2.4% of participants continuing semaglutide and 2.2% of those switching to placebo to stop treatment.