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Blends

Cagrilintide / Semaglutide

Prepared by the ezGLP team. Sources last checked . Profile reviewed .

Also known as CagriSema, Cagrilintide + Semaglutide

Routes represented in the knowledgebase: Subcutaneous (SubQ).

Educational overview

Cagrilintide / Semaglutide is listed in the ezGLP knowledgebase under Blends. Evidence and regulatory status can vary by formulation, route, and jurisdiction.

Cagrilintide/semaglutide, developed by Novo Nordisk under the name CagriSema, is a once-weekly subcutaneous combination of two peptides that act on different receptors. Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. Cagrilintide is a long-acting analogue of amylin, the hormone co-secreted with insulin by pancreatic beta cells, and it signals through amylin and calcitonin receptors concentrated in the area postrema and neighbouring hindbrain regions. GLP-1 activity reduces appetite and slows gastric emptying, while amylin activity promotes satiation by a separate route. The stated rationale is additive appetite suppression, delivered in trials as a fixed-dose combination from a dual-chamber pen.

Development moved from a phase 2 trial in type 2 diabetes, published in the Lancet in 2023, into the phase 3 REDEFINE programme. REDEFINE 1 randomised 3417 adults with overweight or obesity and without diabetes to the combination, to each component alone, or to placebo for 68 weeks, and reported mean body-weight change of roughly minus 20 percent with the combination against about minus 3 percent with placebo, with each single agent falling between those values. REDEFINE 2 studied adults with type 2 diabetes over the same period and reported a smaller mean reduction. Further phase 3 results, including a trial conducted in Japan and Taiwan, appeared during 2026.

No regulator had approved cagrilintide/semaglutide at the time of this review. Novo Nordisk submitted a United States new drug application in December 2025 on the strength of REDEFINE 1, seeking an indication for weight management in adults with obesity or with overweight plus at least one weight-related condition, and the FDA review was expected to conclude during 2026. Cagrilintide is not a component of any approved medicine; the FDA states that it has not been found to be effective and acceptably safe for any condition and cannot lawfully enter compounding. Vials sold online as CagriSema blends are unapproved products of unverified composition.

Because no approved label exists, there is no regulator-reviewed storage, in-use or beyond-use information outside a trial protocol, where the sponsor supplies a refrigerated dual-chamber pen. Grey-market material sold under the CagriSema name is typically a lyophilised powder holding two peptides at a vendor-chosen ratio, and neither that ratio nor the identity, purity and sterility of the contents is verified. An inventory record therefore has to carry the stated amount of each component, the supplier, batch identifier, reconstitution date, resulting concentration and storage temperature; without those fields a dose log entry cannot be compared with the published trials or investigated afterwards.

Category
Blends
Routes represented
Subcutaneous (SubQ)
Storage context
Follow the dispensed product label; storage and in-use limits vary by brand and formulation.

Published literature

Safety evidence

Common or reported: nausea, vomiting, diarrhea, constipation, abdominal pain or indigestion, decreased appetite.

Serious or important: pancreatitis, gallbladder disease, dehydration-related kidney injury, severe GI reactions, hypoglycemia with insulin or secretagogues, hypersensitivity.

Product labels also carry thyroid C-cell tumor warnings.

Safety evidence source

Interaction evidence

These are general, pairwise evidence notes. Green identifies the potential-synergy category, while Lv3/Lv2/Lv1 communicates evidence strength; it does not guarantee benefit or cancel a safety warning.

With insulin or insulin secretagogues

Safety flag

Combined glucose lowering increases hypoglycemia risk, including severe hypoglycemia.

Interaction evidence source

With another GLP-1 receptor agonist

Safety flag

Weight-management labels say coadministration with the same active ingredient or another GLP-1 receptor agonist is not recommended.

Interaction evidence source

With narrow-index or threshold-dependent oral medicines

Safety flag

Delayed gastric emptying can alter the timing or extent of oral-drug absorption.

Interaction evidence source

With Pramlintide

Safety flag

Additive gastric-emptying delay, GI intolerance, and glucose lowering are plausible; a broad clinical contraindication is not established.

Interaction evidence source

Common questions

Is CagriSema FDA approved?

No. At this review cagrilintide/semaglutide had not been approved by the FDA, the European Medicines Agency or any other regulator. Novo Nordisk filed a United States new drug application in December 2025 based on the REDEFINE 1 trial, and a first review decision was expected during 2026. Until an approval is granted there is no licensed product, and material sold online under the name is unapproved.

How much weight did people lose on CagriSema in trials?

In REDEFINE 1, a 68-week phase 3 trial in 3417 adults with overweight or obesity and without diabetes, mean body-weight change was roughly minus 20 percent with the combination and about minus 3 percent with placebo, while semaglutide alone and cagrilintide alone fell between those figures. REDEFINE 2, in adults with type 2 diabetes, reported a smaller mean reduction, a pattern familiar from other incretin programmes.

How is CagriSema different from semaglutide alone?

It adds cagrilintide, a long-acting amylin analogue, to the same GLP-1 receptor agonist. Amylin and GLP-1 signal through separate receptors and partly separate hindbrain circuits, so the combination is intended to reduce appetite by two routes rather than one. REDEFINE 1 included a semaglutide-alone arm, and mean weight loss with the combination exceeded that seen with either component by itself.

Is compounded cagrilintide and semaglutide the same as CagriSema?

No. CagriSema is an investigational fixed-dose product manufactured to a trial specification, and no regulator has yet completed a review of it. Blends sold by online vendors are unapproved preparations whose ratio, identity, purity and sterility are unverified. The FDA states that cagrilintide has not been shown effective and acceptably safe for any condition and cannot lawfully enter compounding, and it has warned about unapproved GLP-1 products generally.

What side effects were reported with CagriSema?

Gastrointestinal events dominated in the REDEFINE trials: nausea, vomiting, diarrhoea and constipation, most frequent while doses were being escalated and mostly mild to moderate in severity. Discontinuation for adverse events was more common with the combination than with placebo. Because the programme has followed several thousand participants for around a year, uncommon and long-term effects remain uncharacterised and no regulator has completed a safety review.

Further reading

Summarised from published literature for reference only, with citations to the source. Evidence is graded as reported and is not a recommendation to combine, dose, or use any compound.

For personal tracking and education only. Not medical advice, diagnosis, or treatment, and not a medical device. Peptides may be prescription-only or unapproved where you live. Consult a licensed healthcare professional.