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Cagrilintide

Long-acting amylin analogue, investigational (studied with semaglutide as CagriSema)

0.25MG
Dose
10U
Draw
476D
Cycle

Cagrilintide is an investigational long-acting amylin analogue. It is not approved alone. The phase 3 REDEFINE 1 trial gave once-weekly subcutaneous cagrilintide 2.4 mg alone, semaglutide 2.4 mg alone, both together (CagriSema) or placebo for 68 weeks. No label dose exists.

PTSEALEDCAGRILINTIDE5 MGLYOPHILIZED
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Protocols

  • Reference to the REDEFINE 1 target dose (escalation not encoded)recommended

    Trial data only: REDEFINE 1 cagrilintide arm. A trial report says dosing started at 0.25 mg and rose every 4 weeks to 2.4 mg by week 16; the intermediate 0.5, 1 and 1.7 mg steps mirror the semaglutide ladder and were not confirmed from the paper itself.

Dosing

  • REDEFINE 1 (https://clinicaltrials.gov/study/NCT05567796): once-weekly subcutaneous injection, 16-week dose escalation, then 52 weeks of maintenance (68 weeks total). Cagrilintide-alone arm: 2.4 mg (https://pubmed.ncbi.nlm.nih.gov/40544433/).
  • The escalation steps (starting dose and increments) were not found in any fetched source: the registry says only '16-week dose escalation'. Do not start at 2.4 mg.
  • The trial let investigators keep patients on a submaximal dose if judged best (ACC summary).

Route & timing

Route: Subcutaneous, once weekly (trial).

Timing: No reliable figure found in the sources; ask your prescriber or supplier.

Reconstitution

  • No sourced reconstitution for gray-market lyophilized cagrilintide: No reliable figure found in the sources; ask your prescriber or supplier.
  • The water in the protocol is arithmetic for a readable draw only: a 5 mg placeholder vial in 2 mL gives 2.5 mg/mL, so 2.4 mg = 96 units in a 100-unit syringe. Vial size is a placeholder; gray-market vials are sold from 1 to 10 mg (Midi).

Reconstitution calculator

Concentration
2.5 mg/mL
Per unit
0.025 mg
Draw
10 units
Volume
0.1 mL
Doses per vial
20
Vials for cycle (68 doses), pooled
4
Vials, discard remainder
4
concentration = 5 / 2 = 2.5 mg/mL
per unit = 2.5 / 100 = 0.025 mg
units = 0.25 / 0.025 = 10
mL = 10 / 100 = 0.1
doses per vial = 5 / 0.25 = 20
pooled vials = ceil(0.25 x 68 / 5) = 4
discard vials = ceil(68 / floor(20)) = 4

Stability

No reliable figure found in the sources; ask your prescriber or supplier.

Off-cycle

The trial ran continuously for 68 weeks; no rest period is described.

Why:

  • No source gives an off-cycle.

Stacking rules

  • Never draw into the same syringe as another compound; use separate syringes and distinct injection sites.
  • CagriSema (with semaglutide) is the studied combination; combining GLP-1 products on your own is not covered by any label.

Safety

Investigational; not FDA-approved alone. CagriSema was reported filed with the FDA (Midi, filed Dec 2025). Not prescribable, so any vial comes from an unregulated channel with unknown identity, dose and sterility.

Common side effects:

  • CagriSema vs placebo in REDEFINE 1: gastrointestinal events 79.6% vs 39.9% (nausea, vomiting, diarrhea, constipation, abdominal pain), mostly transient and mild to moderate (PubMed). Cagrilintide-alone rates were not found.

Stop and call your prescriber if:

  • Severe persistent abdominal pain, repeated vomiting or dehydration.
  • Signs of allergic reaction or injection-site infection.
  • For the GLP-1 component, see the semaglutide entry (boxed thyroid C-cell warning); cagrilintide-alone safety warnings are not established.

Labs and monitoring:

  • No monitoring schedule was found in the sources.

Markers to track

What sources report this compound changes, or say to check. A record of the evidence, not targets or advice.

Sources

Cagrilintide