Cagrilintide: what the evidence shows

What the human research shows

The first serious non-incretin addition to the weight-loss toolkit. The combination data are published and large, which is why the grade is B rather than D — but nothing is approved, and the standalone effect is modest next to what it is combined with.

Evidence profile0–5

Metabolic & weightB3.5
Cardiovascular—0.0
Muscle & growth—0.0
Healing & repair—0.0
Neuro & sleep—0.0
Immune & inflammation—0.0
Sexual & hormonal—0.0
Skin & appearance—0.0
Ageing & longevity—0.0

Each score is confidence × effect size, taken from the best-evidenced benefit in that domain: the grade (A–D) sets the confidence, the measured effect sets the size. Hover a domain to see the outcomes behind it. Adverse effects are excluded and listed separately below.

Outcome	Grade	Effect size	Human studies	Where the evidence comes from
Body weight (with semaglutide, CagriSema)	BProbable	Large	1 large phase 3 RCT	REDEFINE 1: −22.7% at 68 weeks in 3,417 adults vs −16.1% semaglutide alone, −11.8% cagrilintide alone, −2.3% placebo (trial-product estimand, i.e. while on treatment). The abstract's intention-to-treat figure is −20.4% vs −3.0%. 40.4% lost at least a quarter of body weight. The combination has its own page.1
Body weight (alone)	BProbable	Moderate	Phase 2 + phase 3 arm	−11.8% at 68 weeks as monotherapy in REDEFINE 1 — meaningful, but below the incretin drugs.1
GI side effectsadverse	BProbable	Moderate	Phase 3	Mostly mild-to-moderate nausea and vomiting, easing over time; the profile reported as consistent with GLP-1 drugs.1

AMultiple good human trials, consistentBSome human trials, mostly consistentCFew or weak human studiesDAnimal or anecdotal onlyeffect size · red = adverse

Literature searched to 2 September 2026. Human studies only; animal and cell work informs the mechanism section and nothing else.

Registered trials

ClinicalTrials.gov lists 44 interventional studies naming Cagrilintide as an intervention — 24 completed, 11 recruiting, and 1 with results posted to the registry.

A registration is not a result. Anyone can register a study, and many never report — so this list shows what has been attempted, not what has been shown. The graded evidence above is the answer to whether something works.

Study	Phase	Status	Participants	Sponsor	Results
Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 DiabetesNCT04982575 · started Aug 2021	Phase 2	Completed	92	Novo Nordisk A/S	Posted
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood VesselsNCT05669755 · started Mar 2023	Phase 3	Active not recruiting	7,101	Novo Nordisk A/S	None
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose WeightNCT05567796 · started Nov 2022	Phase 3	Active not recruiting	3,400*	Novo Nordisk A/S	None
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 InhibitorNCT06065540 · started Sept 2023	Phase 3	Completed	2,734	Novo Nordisk A/S	None
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose WeightNCT07564414 · started May 2026	Phase 3	Recruiting	2,500*	Novo Nordisk A/S	None
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose WeightNCT05394519 · started Feb 2023	Phase 3	Completed	1,200	Novo Nordisk A/S	None
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 InhibitorNCT06221969 · started Jan 2024	Phase 3	Completed	1,024	Novo Nordisk A/S	None
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or BothNCT06534411 · started Nov 2024	Phase 3	Completed	1,023	Novo Nordisk A/S	None

36 further studies are registered. Participant counts marked * are the sponsor's estimate, not a final enrolment. Source: ClinicalTrials.gov, read directly from the registry and refreshed weekly.

What it is

Amylin is co-secreted with insulin and slows gastric emptying and promotes satiety. An earlier analogue, pramlintide, required several injections a day. Cagrilintide is engineered to last a week, which is what makes a combination product practical.

Novo Nordisk's strategy is the combination: cagrilintide plus semaglutide in one injection, branded CagriSema, on the theory that two different satiety pathways add up. REDEFINE 1 is the trial that tested it.

How it is thought to work

Amylin receptors in the brainstem contribute to meal termination through a pathway distinct from GLP-1. Because the mechanisms differ, the effects appear at least partly additive rather than redundant — which is the case for the combination.

What is still unknown

Whether it will be approved, and when.
Long-term durability and what happens on stopping.
Whether the modest standalone effect has a role of its own.

The molecule and how long it lasts

Identity

Formula: C194H312N54O59S2
Molecular weight: 4409 g/mol
CAS number: 1415456-99-3
PubChem: CID 171397054

PubChem record, read 23 September 2026.

Pharmacokinetics

Route: Subcutaneous, once weekly
Half-life: About 7–8 days (159–195 hours)

From a published human pharmacokinetic study: Enebo LB, et al. Safety, tolerability, pharmacokinetics and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg: a phase 1b trial. Lancet 2021

Regulatory status

European Union

Investigational; not authorised

In phase 3 (with semaglutide as CagriSema). No authorisation; supply outside trials is unlawful.

United States

Investigational; cannot be compounded

FDA: cagrilintide 'cannot be used in compounding under federal law'. Not a component of any approved drug.

United Kingdom

Unlicensed

Investigational; supply outside trials is an offence.

Australia

Unapproved

Not on the ARTG; prescription-only substance with no lawful supply outside trials.

Canada

Not authorised

Investigational; no DIN.

Sport (WADA)

Prohibited at all times

Unapproved anywhere, so it falls under S0 (non-approved substances).

Questions people actually ask

Is CagriSema better than semaglutide?

In REDEFINE 1, yes: 22.7% versus 16.1% at 68 weeks in the same trial. It fell short of the 25% figure the market had expected, which is why the result was reported as a disappointment despite being the larger number.

What is amylin?

A hormone released with insulin after eating that signals fullness and slows stomach emptying. Cagrilintide is a version engineered to last about a week.

Can you buy cagrilintide?

Not legally. It is investigational; anything sold under the name is unlicensed and of unknown content.

One page per claimed effect

BDoes Cagrilintide help with body weight?1 large phase 3 RCT
BDoes Cagrilintide help with body weight?Phase 2 + phase 3 arm
BHow common is GI side effects with Cagrilintide?Phase 3

References

1
Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1).N Engl J Med, 2025; DOI 10.1056/NEJMoa25020813,417 adults, 68 weeks, four arms.

Change log

2026-09-02Initial publication from the published REDEFINE 1 trial.