Key Takeaways
- Combines semaglutide + cagrilintide (amylin analogue) in one weekly injection
- Phase 3 REDEFINE 1: 22.7% average weight loss over 68 weeks
- ~31% of participants lost 25% or more of body weight
- Significantly more weight loss than semaglutide alone (~15%)
- Potential approval: 2026–2027
- Not currently available — semaglutide and tirzepatide are
What Is CagriSema?
CagriSema is being developed by Novo Nordisk. It pairs two active ingredients: semaglutide 1.8mg (the same GLP-1 agonist in Wegovy and Ozempic) and cagrilintide 2.4mg, a long-acting synthetic analogue of amylin — a hormone secreted by the pancreas alongside insulin.
Amylin slows gastric emptying, reduces glucagon after meals, and creates satiety signals — through pathways entirely separate from GLP-1. Targeting both simultaneously appears to produce substantially more weight loss than either approach alone.
| CagriSema | Wegovy (Sema) | Zepbound (Tirz) | Retatrutide | |
|---|---|---|---|---|
| Mechanism | GLP-1 + Amylin | GLP-1 | GLP-1 + GIP | GLP-1 + GIP + GCG |
| Avg weight loss | 22.7% | ~15% | ~20–22% | ~24% |
| Phase | Phase 3 | Approved | Approved | Phase 3 |
| Est. approval | 2026–2027 | Approved | Approved | 2027–2028 |
REDEFINE Trial Results
The REDEFINE 1 Phase 3 trial enrolled over 3,400 adults with obesity for 68 weeks. CagriSema produced 22.7% average weight loss versus 2.3% for placebo. About 31% of CagriSema patients lost 25% or more of body weight.
Approval Timeline
| Milestone | Estimated Timing |
|---|---|
| REDEFINE program results | 2024–2025 |
| NDA submission | 2025–2026 (estimated) |
| FDA review | 12 months |
| Earliest approval | 2026–2027 |
See all pipeline drugs at the future GLP-1 hub, the approval timeline, or the full comparison.
Frequently Asked Questions
What is CagriSema?
CagriSema combines semaglutide (the active ingredient in Wegovy) with cagrilintide, a new amylin analogue, in a single weekly injection developed by Novo Nordisk.
How much weight loss did CagriSema show?
The REDEFINE 1 Phase 3 trial showed 22.7% average body weight loss over 68 weeks — more than semaglutide alone and comparable to tirzepatide.
When will CagriSema be approved?
Based on REDEFINE trial timelines, NDA submission could come in 2025–2026, with potential FDA approval as early as 2026–2027.
How does CagriSema differ from Wegovy?
Both contain semaglutide. CagriSema adds cagrilintide — an amylin analogue — which targets a separate hormonal pathway and produced about 7–8 percentage points more weight loss than semaglutide alone in Phase 3.
Is CagriSema available?
No. It is investigational. Semaglutide (Wegovy) and tirzepatide (Zepbound) are available now through licensed providers.
Wegovy is available today.
CagriSema adds amylin to semaglutide — but semaglutide alone is FDA-approved and producing 15% average weight loss through telehealth providers right now.
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