CagriSema Dosage: Trial Schedule & Filing Status
Last updated May 19, 2026 · Reviewed by Grey Peptides Editorial Board · ⚠️ Investigational — trial data only
← CagriSema encyclopedia entry · See also: Semaglutide dosage · Tirzepatide dosage
CagriSema is investigational. Novo Nordisk filed an FDA New Drug Application in December 2025, but it was not yet approved at the time of writing. The doses below come from the REDEFINE clinical trials and apply only within supervised studies. This page is educational — not a protocol.
The short version
CagriSema is a fixed-dose combination of two molecules: cagrilintide (a long-acting amylin analog) and semaglutide (the familiar GLP-1 agonist). The idea is complementary appetite pathways — amylin and GLP-1 acting through distinct receptors — combined in one weekly injection. It is one of the closest next-generation obesity drugs to a regulatory decision, which makes its trial dosing worth understanding, with the firm caveat that it is not yet an approved product.
The trial regimen
In the REDEFINE program, CagriSema is given once weekly by subcutaneous injection as a fixed combination of cagrilintide 2.4 mg + semaglutide 2.4 mg, reached through a stepwise titration to limit gastrointestinal side effects.
| Parameter | As used in trials |
|---|---|
| Components | Cagrilintide 2.4 mg + semaglutide 2.4 mg |
| Route | Subcutaneous |
| Frequency | Once weekly |
| Titration | Stepwise up-titration |
| Status | NDA filed Dec 2025 (not approved) |
→ Plan this schedule in the GLP-1 Titration Planner — pick a target dose and start date for a dated, week-by-week plan and an escalation chart.
On efficacy, the REDEFINE 1 obesity trial reported roughly 23% mean weight loss at 68 weeks, ahead of either component alone, while REDEFINE 2 (type 2 diabetes) reported about 15.7%. Notably, in the head-to-head REDEFINE 4 trial the 2.4/2.4 mg dose did not meet non-inferiority versus tirzepatide 15 mg, and higher-dose combinations are being explored — useful context that the highest number is not the whole story.
Regulatory status
The FDA filing in December 2025 places a regulatory decision on the horizon, but until an approval is issued, CagriSema is investigational and available only through trials. As with the other incretins, any "research" CagriSema sold outside that channel is not the trial product. For the approved members of the class, see the semaglutide and tirzepatide dosage pages; for the investigational frontier, the retatrutide hub.
Frequently asked questions
How is CagriSema different from Wegovy?
Wegovy is semaglutide alone; CagriSema adds the amylin analog cagrilintide to semaglutide, targeting a second appetite pathway in one injection.
Why did it miss against tirzepatide if it hit 23%?
Different trials and endpoints: the strong REDEFINE 1 result was versus placebo and single agents, whereas REDEFINE 4 was a tougher head-to-head against high-dose tirzepatide, which it did not beat on the non-inferiority endpoint.
Can I get it now?
Only through clinical trial participation; it is not an approved, prescribable medicine yet.
Sources
- Novo Nordisk — REDEFINE 1 / REDEFINE 2 phase 3 results; FDA NDA submission for CagriSema, December 2025.
- Novo Nordisk — REDEFINE 4 headline results vs tirzepatide 15 mg, February 2026.
Medical disclaimer: Education only, not medical advice. CagriSema is investigational and not yet approved. Trial doses apply only within supervised studies. Consult a licensed clinician.