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CagriSema (Cagrilintide + Semaglutide)

Emerging
aka Cagrilintide + Semaglutide · Cagri-Sema · CagriSema
Weight Management Not FDA-approved; Novo Nordisk filed a New Drug Application for CagriSema in December 2025, with FDA review expected during 2026.

Educational information only — not medical advice. Many listed compounds are not FDA-approved for human use. Consult a licensed clinician before starting, changing, or stopping any protocol.

Overview

CagriSema is an investigational weight-management therapy that combines two compounds in a single co-formulated, once-weekly injection: cagrilintide, a long-acting amylin analog, and semaglutide, a GLP-1 receptor agonist that is also marketed on its own as Wegovy and Ozempic. The two are paired in a 1:1 ratio, and Novo Nordisk has positioned it as the first once-weekly combination of a GLP-1 agonist and an amylin analog developed for chronic weight management.

The pairing is built on the idea that the two hormones act through complementary appetite pathways, so combining them may produce a larger effect than either component alone. Across the phase 3 REDEFINE program, the combination was studied for greater average weight reduction than cagrilintide or semaglutide given individually.

CagriSema is not currently approved by the FDA or other major regulators. Novo Nordisk submitted a New Drug Application to the FDA in December 2025, and regulatory review is expected during 2026.

How it works

Semaglutide mimics GLP-1, a hormone that reduces appetite and slows gastric emptying, while cagrilintide mimics amylin, a hormone that enhances satiety signaling and helps regulate glucagon. Because the two act through distinct but complementary systems that influence hunger and fullness, combining them is thought to reinforce the appetite-suppressing effect and support metabolic changes.

In the REDEFINE trials, the combination was also associated with improvements in measures such as waist circumference, blood pressure, lipids, and glycemic control. The extent to which each component contributes to any individual outcome is still being characterized as the clinical program matures.

Reported benefits

  • Substantial average weight reduction in phase 3 trials, reported as greater than either component alone
  • Improvements in cardiometabolic markers such as waist circumference, blood pressure, and lipids (studied)
  • Better glycemic control, including in participants with prediabetes or type 2 diabetes (studied)
  • A single once-weekly injection combining two mechanisms

These are outcomes reported in clinical studies of the combination, not guaranteed individual results.

Considerations & side effects

As with other GLP-1-based therapies, the most commonly reported side effects in trials were gastrointestinal — nausea, vomiting, diarrhea, constipation, and abdominal discomfort — which were generally mild to moderate and tended to ease over time. Because CagriSema is investigational and not yet approved, its full long-term safety and tolerability profile in broad clinical use is still being established.

The compound has been studied under structured clinical protocols with gradual dose escalation, and outcomes seen in those trials may not translate to unsupervised or non-clinical settings. It is not a substitute for evaluation and treatment by a qualified clinician.

Frequently asked

What is CagriSema?

CagriSema is an investigational fixed-dose combination pairing cagrilintide, a long-acting amylin analog, with semaglutide, a GLP-1 receptor agonist. Developed by Novo Nordisk, it is designed as a single once-weekly injection for chronic weight management.

Is CagriSema FDA-approved?

Not yet. Novo Nordisk submitted a New Drug Application to the FDA in December 2025, and review is expected during 2026. If approved, it would be the first once-weekly combination of a GLP-1 agonist and an amylin analog for weight management.

What are its two components?

Cagrilintide, an amylin analog that enhances satiety signaling, and semaglutide, the GLP-1 agonist also sold as Wegovy and Ozempic. The two are combined in a 1:1 ratio in a single co-formulated product.

How does it compare to either drug alone?

In the phase 3 REDEFINE program, the combination was associated with greater average weight reduction than cagrilintide or semaglutide given on their own, which is the rationale for pairing the two mechanisms.

References

  1. Garvey WT, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1). N Engl J Med.
  2. Davies MJ, et al. Cagrilintide–Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (REDEFINE 2). N Engl J Med.
  3. Novo Nordisk files for FDA approval of CagriSema (press release).

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