Investigational amylin/GLP-1 combination · Fact sheet
CagriSema
Also known as Cagrilintide–semaglutide
CagriSema combines cagrilintide and semaglutide and has direct phase 3 human evidence for weight reduction. The combination is under FDA review; approved semaglutide products do not confer approval on CagriSema or on independently mixed products.
What is CagriSema?
Cagrilintide targets amylin receptors, while semaglutide targets GLP-1 receptors. This entry concerns the studied combination.
An experimental combination product is distinct from an approved single ingredient and from online mixtures.
Benefits & claims
Interest centers on additional weight reduction beyond either ingredient alone and on glucose control.
What the evidence supports
- REDEFINE 1 demonstrated greater average weight reduction than placebo in its defined adult population.
- The 20.4% estimate includes the trial treatment-policy assumptions; larger estimates based on adherence answer a different statistical question.
- The trial supports the studied formulation and population, not equivalence of independently mixed research products.
Research areas
- Weight management
- Type 2 diabetes
Dosage & frequency
Human study contextREDEFINE 1 provides a combination-trial target dose, not an approved prescribing schedule.
REDEFINE 1 (NCT05567796)
Adults without diabetes with BMI at least 30, or at least 27 plus an obesity-related complication
- Amount
- Target doses of cagrilintide 2.4 mg and semaglutide 2.4 mg
- Frequency
- Once weekly within a 68-week trial
- Route studied or labeled
- Subcutaneous study administration
Target amounts followed protocol escalation and permitted dose adjustments; this summary omits the full titration and tolerability rules. All groups received lifestyle intervention. Independent mixtures were not tested.
How to read these amounts
An approved regimen belongs to a specific product, indication, and population. A study regimen describes what researchers tested; it does not establish a prescription or a safe self-use protocol. Products, routes, and formulations are not interchangeable. A prescriber uses the full label and individual clinical circumstances.
Personal accounts may describe amounts, schedules and outcomes beyond clinical research. They do not establish a regimen. Read the reported experiences
Formulations, interactions & practical context
- Identity and pharmacology
- Cagrilintide targets amylin receptors, while semaglutide targets GLP-1 receptors. This entry concerns the studied combination.
Formulation differences
- An experimental combination product is distinct from an approved single ingredient and from online mixtures.
Interactions & precautions
- The reviewed sources do not establish a comprehensive human interaction profile for this exact substance or combination.
What is still unresolved
- Durability after treatment ends
- Long-term cardiovascular and other clinical outcomes
- Final FDA labeling and exact product presentation
Side effects & risks
- Gastrointestinal adverse events are common in the trial program.
- Long-term outcomes and product-specific contraindications must be assessed for the exact combination; a semaglutide label is not a complete CagriSema label.
This is a summary of the cited evidence, not a complete product label. A lack of human safety data does not establish safety.
Clinical research
Moderate human evidenceREDEFINE 1 randomized 3,417 adults without diabetes. The treatment-policy estimate at 68 weeks was a 20.4% weight reduction with the combination versus 3.0% with placebo. Separate diabetes trials address different populations.
Studies
3,417 participants without diabetes; 68-week randomized study.
Phase 3 study in adults with type 2 diabetes.
Personal experiences
Reports describe what someone noticed. They cannot establish cause, typical results, or how often a side effect happens. Amounts and schedules describe the individual account, not an effective or safe dose. Product identity and strength may be unverified, and missing details are left explicit.
No attributable personal accounts were found in the sources reviewed.
Approval status
Novo Nordisk reports filing the CagriSema weight-management application with FDA in December 2025. A submitted application and phase 3 findings do not establish FDA approval.
Application submitted for FDA review
Approval covers the labeled product, use and population. A trial phase does not establish success; a stopped program is not ongoing research.
Open questions
- Durability after treatment ends
- Long-term cardiovascular and other clinical outcomes
- Final FDA labeling and exact product presentation
Summary
The trial supports the studied formulation and population, not equivalence of independently mixed research products.
Sources
Medical evidence and regulatory sources are listed here. Personal reports are linked separately in the experiences section.
- company releaseNovo Nordisk annual report: CagriSema application
Company primary disclosure of the December 2025 FDA submission; not an approval decision.