Cagrilintide

01 / Dosing schedule

Cited dosing

Cagrilintide is an investigational once-weekly subcutaneous amylin analogue, not FDA approved as a single agent. The phase 2 dose-finding trial tested 0.3, 0.6, 1.2, 2.4 and 4.5 mg once weekly for 26 weeks against placebo and liraglutide 3.0 mg daily.

Cagrilintide phase 2 dose-finding trial (NCT03856047) — once-weekly subQ

Phase	Dose & frequency
Arm 1	0.3 mg once weekly
Arm 2	0.6 mg once weekly
Arm 3	1.2 mg once weekly
Arm 4	2.4 mg once weekly
Arm 5	4.5 mg once weekly
Active comparator	liraglutide 3.0 mg once daily
Escalation	dose-escalation period of up to 6 weeks; per-week steps n.a. in the published methods
Total treatment	26 weeks, then 6 weeks off-treatment follow-up

Source · Lau DCW et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet 2021. ↗

Source indication · Weight management in overweight/obesity without diabetes (Novo Nordisk phase 2 dose-finding, NCT03856047); a separate phase 1b studied cagrilintide co-administered with semaglutide 2.4 mg

Injection frequency: Once weekly (26 weeks in the phase 2 trial). In the phase 1b combination study, cagrilintide and semaglutide were co-escalated at 4-week intervals over 16 weeks, then held at target for 4 weeks.
Injection sites: n.a. — the phase 2 paper describes subcutaneous self-injection and reports administration-site reactions, but names no anatomical site.

02 / Reconstitution

Reconstitution reference

Not applicable: the trials used prefilled investigational injection product, not a lyophilised vial. No reconstitution step appears in the cited publications.

Vialn.a. (trial product supplied ready to inject)

BAC watern.a.

Concentrationn.a.

Example dosen.a.

On a U‑100 syringen.a.

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03 / Overview

Protocol overview

Cagrilintide is a long-acting acylated amylin analogue. In the randomised phase 1b combination trial, cagrilintide 0.16-4.5 mg had a half-life of 159-195 h with median t-max of 24-72 h, which is the pharmacology behind weekly dosing.

The dose-finding evidence is the 26-week phase 2 trial run at 57 sites across ten countries in adults with BMI >=30, or >=27 with hypertension or dyslipidaemia and no diabetes. Five once-weekly subcutaneous doses were compared with volume-matched placebo and with liraglutide 3.0 mg daily.

Escalation was capped at 6 weeks, but the Lancet methods do not print which dose was given in which escalation week, so an honest page reports the target doses and the escalation window rather than a fabricated weekly ladder. Mean weight reductions across cagrilintide doses were 6.0-10.8% (6.4-11.5 kg), versus 3.0% on placebo and 9.0% on liraglutide.

Reviews of the wider programme record the escalation patterns actually used in specific trials, for example 0.6 mg weekly doubled every two weeks to 2.4 mg by week 4 in Lau et al., and 0.16 mg weekly stepped up by 0.56 mg every four weeks to 2.4 mg in Enebo et al. Cagrilintide alone is not approved; it is developed mainly as the amylin half of CagriSema.

04 / References