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GLP-1 Trial & Approval Tracker

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SURMOUNT-4 trial results

Adults with overweight or obesity without diabetes who completed a 36-week tirzepatide lead-in.

Mounjaro
Phase
Phase 3
Follow-up
52 weeks
Randomised
670
Sponsor
Eli Lilly
Publication
JAMA · 2023

Randomised withdrawal trial. Treatment-regimen analysis starts after 36 weeks of tirzepatide.

Mean body weight change from week 36 to week 88
  • Continued tirzepatide 10 or 15 mg−5.5%
  • Switched to placebo+14.0%
Mean body weight change from week 36 to week 88
Trial armResult
Continued tirzepatide 10 or 15 mg−5.5%
Switched to placebo+14.0%
Participants who retained at least 80% of lead-in weight loss at week 88
Trial armResult
Continued tirzepatide 10 or 15 mg89.5%
Switched to placebo16.6%

Safety. Gastrointestinal events were the most common adverse events, generally mild or moderate, and more frequent in the tirzepatide group.