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Amylin/GLP-1Investigational · FDA review

CagriSema

Amylin analog (cagrilintide) plus GLP-1 agonist (semaglutide). Once weekly.

CagriSema (investigational)·Novo Nordisk

Catalog reviewed Sep 30, 2026. Feed checks and price reviews are dated separately below. How we verify. Not medical advice.

OverviewDosing & warningsClinical trials

What to know about CagriSema

An ingredient can have several brands, formulations, and approved uses. Prices and trial findings belong to the specific product and dose shown.

Mean weight change in the cited trial
−22.7% (-22.7% at 68 wks · REDEFINE-1 (Phase 3) · 2.4 mg / 2.4 mg weekly (CagriSema))

REDEFINE-1 (Phase 3) · 2.4 mg / 2.4 mg weekly (CagriSema)

Stopped treatment for adverse events
6% (6% vs 3.7% placebo · REDEFINE 1 (2.4/2.4 mg, obesity))

REDEFINE 1 (2.4/2.4 mg, obesity)

FDA shortage report
In development

Investigational. Not FDA-approved.

Route & frequency
Once weekly

Trial averages are not personal predictions. Weight-loss, A1c, and side-effect figures may come from different trials, doses, or populations; follow each source for its context.

Indications

Investigational uses

CagriSema (investigational)

Obesity; type 2 diabetes (investigational)

Obesity (investigational)Type 2 diabetes (investigational)

An investigational fixed combination of the long-acting amylin analog cagrilintide and semaglutide, pairing two complementary satiety pathways.

Product labeling

Dosing, warnings & contraindications

Choose the named product and route. These are submitted label records, which may differ from current approved prescribing information. The product links above lead to current prescribing information. Indexed text omits tables and images; always read the full source label.

No approved label (investigational)

CagriSema is investigational. See its registered studies below. Search DailyMed.

Source: submitted product labeling via openFDA. A listing does not establish FDA approval and may differ from current approved labeling. Read the current prescribing information and consult a clinician.
Tolerability

Side effects reported in the trial

Reported adverse events and treatment discontinuation from the cited trial. These figures do not predict an individual response.

Discontinued for side effects

6% (6% vs 3.7% placebo · REDEFINE 1 (2.4/2.4 mg, obesity))

Reported as 6% vs 3.7% placebo. The share of trial participants who stopped treatment because of adverse events. This does not measure all side effects or all reasons for stopping.

Had nausea

55% (Nausea in the drug arm · REDEFINE 1 (2.4/2.4 mg, obesity))

The share of participants who reported nausea in this trial. Severity and duration are not captured by this percentage.

GI events dominated (nausea 55%, constipation 31%, vomiting 26%), mostly transient and mild-to-moderate; despite high nausea, AE discontinuation stayed relatively low.

From REDEFINE 1 (2.4/2.4 mg, obesity). Tolerability figures come from each drug's own trial (different doses, durations, and populations), so compare them as a guide, not a head-to-head. Source.

Studied together

Direct trial comparisons

Read the results for the exact products, doses, and participants studied.

  • REDEFINE-4: CagriSema vs tirzepatide

    Adults with obesity and at least one associated condition. 84 weeks. Sponsor announcement.

Evidence

Clinical trials

29 of 31 registered studies indexed. Showing up to 12 records: posted results first, then late-phase trials. Registry counts are not a measure of evidence quality.

  • REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
    NCT05669755PHASE3Active_not_recruiting7,101 enrolled
  • A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
Related

Related GLP-1s to compare

Semaglutide
Ozempic, Wegovy, Wegovy HD, Rybelsus
Tirzepatide
Mounjaro, Zepbound
Liraglutide
Victoza, Saxenda
Orforglipron
Foundayo
Questions

Common questions about CagriSema

How much weight can you lose on CagriSema?
In its pivotal trial (REDEFINE-1 (Phase 3)), CagriSema at 2.4 mg / 2.4 mg weekly (CagriSema) showed a mean body-weight change of -22.7% at 68 wks. This is a trial average; individual results vary. Source
Is CagriSema available yet?
No. CagriSema is investigational (FDA review) and not FDA-approved, so it cannot be prescribed or bought yet.
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Fazier
NCT05567796
PHASE3
Active_not_recruiting
3,400 enrolled
  • A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight…
    NCT06065540PHASE3Completed2,734 enrolled
  • A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With…
    NCT07564414PHASE3Recruiting2,500 enrolled
  • A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
    NCT05394519PHASE3Completed1,200 enrolled
  • A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2…
    NCT06534411PHASE3Completed1,023 enrolled
  • A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
    NCT06131437PHASE3Completed809 enrolled
  • A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
    NCT07253285PHASE3Recruiting460 enrolled
  • A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
    NCT06780449PHASE3Active_not_recruiting400 enrolled
  • A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight
    NCT05813925PHASE3Completed331 enrolled
  • A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight
    NCT05996848PHASE3Completed300 enrolled
  • A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight
    NCT06388187PHASE3Completed300 enrolled
  • Source: ClinicalTrials.gov API v2 · as of Oct 3, 2026

    All trials on ClinicalTrials.gov