Cagrilintide

What it is

Cagrilintide is a long-acting analogue of amylin, a hormone the pancreas releases with insulin that promotes a feeling of fullness [2]. It was developed by Novo Nordisk as a stable, lipidated version of amylin designed for once-weekly injection, in contrast to the older amylin analogue pramlintide, which needs three daily injections [3]. In trials it has been studied on its own and in a fixed-dose combination with the GLP-1 receptor agonist semaglutide, which Novo Nordisk calls CagriSema [6]. Its development code names include NNC0174-0833, the name used in the phase 2 trial registration [2]. Cagrilintide is investigational: it is not an approved drug anywhere in the US or EU as of the December 2025 filing [6].

How it works

Amylin is a pancreatic hormone that induces satiety, and cagrilintide is built to mimic it with a much longer duration of action [2]. Natural amylin tends to clump into amyloid fibrils, which made a long-acting version hard to design; cagrilintide solves this with a stabilised, lipidated peptide structure selected for once-weekly dosing [3]. In the phase 1b trial, exposure rose in proportion to the cagrilintide dose and did not change how semaglutide was absorbed or cleared, which supported giving the two together [1]. The combination targets two complementary pathways in appetite regulation, an amylin pathway and a GLP-1 pathway, which is the rationale for CagriSema [6]. Glycaemic measures improved in all treatment groups of the phase 1b trial regardless of cagrilintide dose [1].

What the evidence shows

In the 26-week phase 2 trial of 706 adults with overweight or obesity, once-weekly cagrilintide across 0.3–4.5 mg produced mean weight reductions of 6.0%–10.8% versus 3.0% with placebo [2]. The highest tested dose, 4.5 mg, produced greater weight loss than once-daily liraglutide 3.0 mg (10.8% vs 9.0%) [2]. In REDEFINE 1, a 68-week phase 3 trial of 3,417 adults without diabetes, cagrilintide-semaglutide at 2.4 mg each reduced body weight by an estimated 20.4% versus 3.0% with placebo [4]. In REDEFINE 2, 1,206 adults with type 2 diabetes and overweight or obesity lost 13.7% versus 3.4% with placebo over 68 weeks [5]. In REIMAGINE 2, a phase 3 trial in 2,728 adults with type 2 diabetes, CagriSema lowered HbA1c and weight more than semaglutide alone [9]. These figures describe published trials, not what any individual should expect.

Regulatory status

Cagrilintide is investigational; the phase 2 trial and the REDEFINE phase 3 program were funded by Novo Nordisk [2][4]. On December 18 2025 Novo Nordisk submitted a New Drug Application to the FDA for once-weekly CagriSema, the fixed-dose combination of cagrilintide and semaglutide, for weight management in adults with obesity or overweight with a weight-related condition [6]. The company stated that CagriSema is not approved in the US or EU and that FDA was expected to review the application in 2026 [6]. REDEFINE 1 is registered as NCT05567796 and was listed as active but not recruiting, with completion estimated for October 2026 [7]. Novo Nordisk has also said it will discuss a separate regulatory pathway for CagriSema in type 2 diabetes [9]. As of September 24 2026 we found no FDA approval of cagrilintide alone or of CagriSema. There is no approved cagrilintide product, so any product a prescriber supplies is outside the approved-drug system [6].

Half-life and what it means for a level curve

In the phase 1b trial, once-weekly subcutaneous cagrilintide at 0.16–4.5 mg had a half-life of 159–195 hours, with peak levels reached a median of 24–72 hours after a dose [1]. That trial enrolled otherwise healthy adults aged 18–55 with a BMI of 27.0–39.9, and cagrilintide was given together with semaglutide 2.4 mg [1]. The reference half-life in STACK is 177 hours. That is the midpoint of the published range, about 7.4 days, chosen because the source reports a range across dose groups rather than one value. With a half-life this long, each weekly dose lands before the previous one has cleared, so the estimated level climbs over several weeks and reaches about 97% of steady state after roughly five half-lives, around five weeks of regular dosing. STACK’s curve is an estimate from this published half-life, not a blood level. It also assumes the phase 1b kinetics apply to you, which has not been tested in every population.

Reported side effects

In the phase 2 trial the most frequent adverse events were gastrointestinal (nausea, constipation and diarrhoea) and reactions at the injection site [2]. Gastrointestinal adverse events occurred in 41%–63% of participants on cagrilintide versus 32% on placebo, driven mainly by nausea (20%–47% vs 18%) [2]. In REDEFINE 1, gastrointestinal adverse events affected 79.6% of people on cagrilintide-semaglutide versus 39.9% on placebo and were mainly transient and mild to moderate [4]. Novo Nordisk reported nausea in 55% (vs 12.6%), constipation in 30.7% (vs 11.6%) and vomiting in 26.1% (vs 4.1%) in that trial, with 5.9% stopping treatment because of adverse events versus 3.5% on placebo [6]. A dedicated QT study in 105 healthy participants found no clinically relevant QTc prolongation after cagrilintide escalated to 4.5 mg [8]. Long-term safety data are still limited to trial populations [4]. Call your prescriber about any side effect that worries you.

Storage and handling

There is no FDA-approved cagrilintide product and therefore no US prescribing label with official storage instructions [6]. In the phase 2 trial the drug was given as once-weekly subcutaneous self-injections under study conditions [2]. If a prescriber has supplied cagrilintide, the label from the dispensing pharmacy or trial site governs storage, and general peptide practice is refrigeration, protection from light and not freezing; ask the pharmacy if the label is unclear. Do not use a vial whose contents look cloudy or discoloured without checking with the pharmacy. If your product is a powder that needs mixing, STACK’s reconstitution calculator does the concentration arithmetic from the numbers on your label; it does not suggest a dose. Keep the pharmacy’s instructions with the vial and record the mixing date in STACK.

What STACK tracks for it

STACK logs each cagrilintide dose exactly as your prescriber wrote it, with the date, time and injection site. From those entries it draws an estimated level curve using the 177-hour reference half-life, which you can replace with your own estimate. It stores the escalation schedule your prescriber gave you so you can see where you are in it, without STACK ever proposing a step. Because weight change is the primary outcome in every cagrilintide trial, STACK charts weight alongside the level curve [2][4]. You can log side effects such as nausea or constipation and their timing against doses, which helps a prescriber judge tolerability [2]. STACK also tracks vial inventory and mixing dates. If cagrilintide is combined with semaglutide, both compounds are logged separately so each curve is visible.

The reference half-life in STACK

STACK's simulator and the app use 177 h (7.4 days) for Cagrilintide: ~7 days (159–195 h across dose groups). Measured in: adults aged 18–55 with BMI 27–39.9 and no other illness, once-weekly subcutaneous cagrilintide given with semaglutide 2.4 mg (phase 1b).

Estimate only. Modelled from the published half-life you selected and the doses you logged — not a measured blood level. Do not use it to make medication decisions.

Free tools for Cagrilintide

Read next

Sources

Every URL below was fetched and checked on 2026-09-24. Bracketed numbers in the text link here.

1. TrialSafety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg for weight management: a randomised, controlled, phase 1b trial (Enebo et al., Lancet 2021)
2. TrialOnce-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 (Lau et al., Lancet 2021)
3. OtherDevelopment of Cagrilintide, a Long-Acting Amylin Analogue (Kruse et al., J Med Chem 2021)
4. TrialCoadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1; Garvey et al., NEJM 2025)
5. TrialCagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (REDEFINE 2; Davies et al., NEJM 2025)
6. OtherNovo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management (Dec 18 2025)
7. TrialNCT05567796 — Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema) Once-weekly in Participants With Overweight or Obesity
8. TrialCagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants (Gabe et al., Diabetes Obes Metab 2024)
9. OtherNovo Nordisk A/S: CagriSema demonstrated superior HbA1c reduction and weight loss in adults with type 2 diabetes in the REIMAGINE 2 trial (Feb 2 2026)