CagriSema is Novo Nordisk's combination of cagrilintide (an amylin analog) and semaglutide (a GLP-1 receptor agonist), both at 2.4 mg weekly. The Phase 3 REDEFINE-1 trial reported 20.4% mean body weight loss at 68 weeks in adults with obesity, and an FDA NDA was submitted in December 2025. The combination works through complementary mechanisms: GLP-1 suppresses appetite centrally while amylin slow

What is the recommended dose of CagriSema?

The typical research dose of CagriSema is Cagrilintide 2.4 mg + Semaglutide 2.4 mg, administered Once weekly via Subcutaneous (weekly). Use the ASCEND calculator for exact syringe draw volumes based on your vial size.

How is CagriSema administered?

CagriSema is typically administered Subcutaneous (weekly), Once weekly, in research cycles of 68 weeks (REDEFINE-1 protocol).

What is the research status of CagriSema?

CagriSema is at the Phase 3 complete, NDA under FDA review (Novo Nordisk) stage of research. FDA status: Not Approved. WADA status: Not Listed.

CagriSema: Mechanism, Dosing & Research Data

Storage Stability

Lyophilized

6-12 months (2-8°C)

Reconstituted

~30 days (2-8°C)

Room temp

Avoid

Mechanism of Action

GLP-1 Component (Semaglutide)

Semaglutide activates GLP-1 receptors in the hypothalamus, reducing hunger signals and increasing satiety. It also slows gastric emptying and reduces glucagon secretion, improving glycemic control.

Amylin Component (Cagrilintide)

Cagrilintide is a long-acting amylin analog that activates amylin receptors in the brainstem, independently reducing food intake and body weight. Amylin also modulates gastric emptying and glucagon secretion through mechanisms distinct from GLP-1.

Complementary Dual Pathway

The combination achieves greater weight loss than either component alone because the two peptides act on different receptor systems and brain regions. There is no pharmacodynamic overlap, the effects are additive, not redundant.

Research Summary

REDEFINE-1 (Obesity, no diabetes)

In 3,417 adults with obesity, once-weekly CagriSema 2.4/2.4 mg for 68 weeks produced 20.4% mean body weight loss vs 3.0% with placebo. Published in the New England Journal of Medicine (2025). This exceeds the ~14.9% seen with semaglutide 2.4 mg alone in the STEP-1 trial.

REDEFINE-2 (Obesity + Type 2 Diabetes)

In the companion trial enrolling adults with obesity/overweight AND type 2 diabetes, CagriSema produced 15.7% mean body weight loss vs 3.1% with placebo at the same dose and duration. Also published in NEJM (2025).

FDA Submission

Novo Nordisk submitted a New Drug Application to the FDA in December 2025 based on the REDEFINE-1 and REDEFINE-2 pivotal trials, with an approval decision anticipated in 2026.

Safety Profile

GI side effects (nausea, vomiting, diarrhea) were the primary adverse events, consistent with the GLP-1 component. No new safety signals beyond what is known for semaglutide.

Research Protocols

Titration Schedule

Both components are titrated upward over 16 weeks to reach the 2.4/2.4 mg maintenance dose. Rapid titration increases GI side effects.

Injection

Subcutaneous injection once weekly, same day each week. Rotate injection sites (abdomen, thigh, upper arm).

Note

CagriSema is not commercially available as of 2026 (NDA under FDA review). Research access requires sourcing each component separately and combining per protocol.

Storage & Handling

Store both components at 2-8°C. Do not freeze. Both are peptide solutions, protect from light and heat. Can be held at room temperature (under 30°C) for up to 28 days once in use (per semaglutide labeling; confirm for cagrilintide per source).

References

[1]Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE-1). N Engl J Med. 2025 Aug 14. PMID 40544433.
[2]Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (REDEFINE-2). N Engl J Med. 2025 Aug 14. PMID 40544432.

Key Terms

Peptide Injection Guide

Subcutaneous injection is the standard administration route for most lyophilized research peptides. The technique is str…

Peptide Reconstitution Guide

Reconstitution is the process of dissolving lyophilized (freeze-dried) peptide powder with a sterile diluent to create a…

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Evidence	B+ · Phase 3
Mol. weight	,
Half-life	,
Peak time	,
Route(s)	Subcutaneous (weekly)
Typical dose	Cagrilintide 2.4 mg + Semaglutide 2.4 mg
Frequency	Once weekly
Cycle	68 weeks (REDEFINE-1 protocol)
Storage	2-8°C
WADA	Not Listed GLP-1 agonists are not on WADA prohibited list as of 2026
FDA	Not Approved NDA submitted to FDA December 2025 based on REDEFINE-1 and REDEFINE-2; decision anticipated 2026. Not yet approved.
Research	Phase 3 complete, NDA under FDA review (Novo Nordisk)

CagriSema