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Fat LossInvestigational — Phase 3Limited human evidence

CagriSema

Novo Nordisk's once-weekly combination of cagrilintide (an amylin analog) and semaglutide. Designed to combine appetite suppression (semaglutide) with satiety + meal-size regulation (cagrilintide). REDEFINE-1 Phase 3 showed ~22.7% weight loss at 68 weeks — strong but below pre-trial expectations.

Educational only — not medical advice. SmartPeptide does not prescribe, diagnose, or treat. Always consult a licensed healthcare provider before using any peptide, supplement, medication, or protocol.

What the research shows

REDEFINE-1 (Phase 3, n≈3,400, 68 weeks): mean weight reduction of ~22.7% on CagriSema vs. ~16.1% on semaglutide alone and ~3% on placebo. Cardiovascular outcomes trial REDEFINE-3 is ongoing. Awaiting full FDA submission package.

What's still experimental

Not yet FDA-approved. The combination's performance vs. retatrutide in head-to-head comparisons is unknown. Optimal dosing and treatment duration are still being characterized. MASH and CV outcome data are pending.

Anecdotal / community reports

Available only through clinical trials. Forum speculation about 'building your own' by stacking compounded cagrilintide with semaglutide is dangerous — formulation stability, dose ratios, and interaction data are not established outside the Novo formulation.

Anecdotal reports are NOT scientific evidence. They reflect personal experience and may not generalize.

FDA approval status

Source: openFDA + DailyMed (NIH/NLM)
No FDA-approved drug label exists for “CagriSema”. This peptide is not currently approved by the FDA as a finished pharmaceutical product. Any commercial product claiming FDA approval should be treated with suspicion.

Doses studied in research

Source: Published clinical trial

What published trials tested or FDA-approved labels specify. Reporting research facts — not a SmartPeptide recommendation.

Phase 3 trialREDEFINE-1 Phase 3 trial (Novo Nordisk)
Indication studied: Weight management (Phase 3 — not FDA-approved)
Citation: REDEFINE-1 Phase 3 (n≈3,400, 68 weeks)
Typical
2.4mg(2,400 µg)
once weekly · subcutaneous

Cagrilintide 2.4mg + semaglutide 2.4mg combination, target dose after 16-week titration

Open calculator

Notes from the source: Combination product. Doses listed are AFTER 16-week titration ramp.

Important framing: The numbers above are what published trials tested or what FDA-approved labels specify. They are NOT a SmartPeptide recommendation for you. Trial doses come paired with screening, monitoring, and clinician oversight. Always consult a licensed clinician before any peptide use.

How clinicians typically protocol this

Third-party reference · not our recommendation

Dosing phases, cycle lengths, and administration timing as listed in a compounding-pharmacy clinician reference guide. Shown so you can see what a real protocol looks like — and bring informed questions to a licensed clinician.

Third-party protocol referenceCompounding-pharmacy clinician protocol reference (Nov 2025)

Dose numbers, frequencies, and cycle lengths in this panel are extracted from a clinician-facing reference protocol distributed by a US-based compounding pharmacy in November 2025. SmartPeptide has paraphrased all descriptive text and adds no endorsement. Always consult a licensed clinician.

Metabolic

Cagrilintide (amylin analog) discussed either standalone or paired with a GLP-1 agonist.

Protocol phases

Standalone: Starting
0.25 mgonce weekly
subcutaneous

for 4 weeks, then step up to 0.5 mg

Standalone: Titration
1 mgonce weekly
subcutaneous

after ≥4 weeks

Standalone: Maintenance
1–2 mgonce weekly
subcutaneous
With GLP-1: Starting
250 µg1–2× weekly
subcutaneous

dosed away from the GLP-1 injection

Maximum
2 mgonce weekly
subcutaneous
Cycle length

Ongoing.

Administration timing

When stacked with a GLP-1, spacing doses across the week is common.

Reported side effects
NauseaConstipation
Reconstitution calculator Storage & reconstitution guide
Not medical advice. SmartPeptide does not prescribe, diagnose, or treat. The protocol above reproduces dose figures from a third-party clinician reference so you can see what compounding-pharmacy guidance typically looks like — it is not a recommendation for you, and it has not been validated against peer-reviewed dose-ranging trials. Many of these compounds are not FDA-approved for human use. Work with a licensed clinician familiar with peptide therapy before considering anything here.

FDA enforcement & recalls

Live · openFDA Drug Enforcement API
No FDA enforcement actions (recalls, market withdrawals, safety alerts) on record for “CagriSema”. This is the expected baseline for most peptides — the absence of recalls does NOT imply general safety, only that no formal FDA enforcement has been initiated against approved formulations.

Mechanism & targets

ChEMBL · UniProt · Open Targets

Molecule (ChEMBL)

View on ChEMBL

Live research

PubMed · ClinicalTrials.gov · Europe PMC · OpenAlex
PubMed papers
110
total
Human studies
0
MeSH: humans
Clinical trials
0
published
Active trials
6
35 total registered

Clinical trials (ClinicalTrials.gov)

All trials for "cagrisema OR cagrilintide semaglutide"

Europe PMC — 445 additional records

Includes EU/UK studies and PubMed Central full-text articles. Often surfaces research weeks before PubMed indexes it.

Human clinical evidence

Semantic Scholar · AI TLDRs · influence-ranked
No indexed human-study summaries found for “cagrisema OR (cagrilintide AND semaglutide)” via Semantic Scholar yet. This is normal for very new or research-only compounds.

Research funding & verification

NIH RePORTER · CrossRef DOI registry

Publication landscape

CrossRef · DOI registry
Indexed works (CrossRef)
7,003
all DOIs registered
Retracted papers
0
no retractions on record
Top funders of indexed research
  • Novo Nordisk211 works
  • Novo Nordisk A/S100 works
  • National Natural Science Foundation of China61 works
  • National Institutes of Health37 works
  • Eli Lilly and Company36 works
  • Novo Nordisk AS13 works

Funder diversity is a credibility signal. Research concentrated in a single drug company's funding warrants more scrutiny than research funded across NIH, charities, and academic grants.

Preprints — cutting edge

bioRxiv · medRxiv · via Europe PMC

Preprints have NOT been peer-reviewed. They are early research shared by authors before formal validation. Treat findings as preliminary.

Showing 6 of 6 preprints indexed by Europe PMC.

Known risks

GI side effects (class-typical for GLP-1 + amylin combination). Pancreatitis signal (rare, class warning), gallbladder events. Not yet FDA-approved — long-term safety still being characterized.

Reported side effects

Nausea, vomiting, diarrhea, constipation, decreased appetite, injection-site reactions. The amylin component may add mild glucose-related effects.

FDA adverse event reports (FAERS)

Updated quarterly by FDA
No reports found in the FDA Adverse Event Reporting System for “CagriSema”. This is normal for research-only peptides that are not marketed as FDA-approved drugs.

What requires medical supervision

Investigational only. Patients should pursue FDA-approved alternatives under prescriber care until approval.

Questions for your clinician

  • How does CagriSema compare to Retatrutide for my situation?
  • Should I wait for CagriSema approval or start on currently-approved options?
  • What baseline + monitoring labs would you recommend if I enroll in a trial?

Editorially curated references

Discussions about CagriSema

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