REDEFINE-4 PHASE3 ACTIVE n=800
Drug: CagriSema · NVO
Study Design
DesignRandomized, parallel-group, open-label, active-controlled
Randomization1:1 (assumed, need to confirm)
BlindingOpen-label (unblinded)
Enrollment800
Duration84 weeks
Treatment Arms
CagriSema 2.4mg cagrilintide + 2.4mg semaglutide SC once-weekly n=400
Tirzepatide (Zepbound) 15mg SC once-weekly (highest approved dose) n=400
Primary Endpoints
[{"id":"ep1","name":">= 25% body weight loss at Week 72","type":"PRIMARY","unit":"%","results":[],"timepoint":"Week 72","description":"Responder rate measuring percentage of patients who achieve at least 25% weight loss. This is a high bar - bariatric surgery typically achieves 25-30% weight loss."},{"id":"ep2","name":">= 30% body weight loss at Week 72","type":"PRIMARY","unit":"%","results":[],"timepoint":"Week 72","description":"Even higher responder rate threshold approaching bariatric surgery levels. If CagriSema can achieve high rates here, it would represent a step-change in medical weight loss."}]
Assessment
OPEN QUESTIONS: 1. What is the exact non-inferiority margin? (e.g., -10 percentage points) 2. Is there a gatekeeping strategy for the two primary endpoints? 3. How is the 84-week duration structured (primary at 72 wks + 12 wk extension)? 4. What is the dose escalation schedule for each arm? 5. Are there pre-specified subgroup analyses (by baseline BMI, diabetes status)? 6. What are the secondary endpoints? INVESTMENT IMPLICATIONS: - NI achieved: Validates NVO next-gen obesity franchise - Superiority: Major win for NVO, pressure on Zepbound pricing - NI failed: Significant setback for NVO obesity pipeline Source: ClinicalTrials.gov NCT06131437
Background & Context
Head-to-head comparison to establish CagriSema positioning versus market-leading Zepbound (tirzepatide) in obesity.
Data from Supabase · Updated 2026-03-24