Cagrilintide on its own: the phase 2 trial and the RENEW phase 3 trials
Prepared by: Research Desk. Sources are linked for verification.
Published 31 October 2026
At a glance
- What it is: cagrilintide (also coded AM833) is a lipidated, long-acting analogue of the pancreatic hormone amylin, developed by Novo Nordisk (Kruse et al., 2021, PubMed)
- Best-known use in trials: as one half of CagriSema, its fixed combination with semaglutide, which this site covered in its REDEFINE article
- On its own: a 26-week phase 2 trial in The Lancet compared five cagrilintide strengths with placebo and liraglutide (Lau et al., 2021, PubMed)
- Phase 3 alone: the RENEW trials test cagrilintide without semaglutide; RENEW 1 and RENEW 2 began in November 2025 and have not reported results as of 31 October 2026
- Status: investigational; we found no regulatory approval for cagrilintide on its own
What the molecule is
Natural amylin is co-secreted with insulin and is linked to satiety. It is hard to turn into a research or drug candidate because it readily forms amyloid fibrils. The older analogue pramlintide has a short half-life, as Novo Nordisk's medicinal chemistry paper notes. The same paper describes the structure-activity work behind cagrilintide, a stable, lipidated, long-acting analogue selected for clinical development with obesity as the indication (Kruse et al., 2021).
A pharmacology study run with Monash University profiled cagrilintide across 25 end points and described it as a nonselective agonist of amylin receptors and of the calcitonin receptor. Amylin receptors are heterodimers of the calcitonin receptor with receptor activity-modifying proteins (RAMPs), so the two targets overlap (Fletcher et al., 2021, PubMed).
The phase 2 trial
The phase 2 trial ran at 57 sites in ten countries in 2019 and enrolled adults without diabetes who had a BMI of at least 30, or at least 27 with hypertension or dyslipidaemia (Lau et al., 2021).
- Design: 706 participants were randomised to one of five cagrilintide strengths (100 to 102 per group), 99 to liraglutide and 101 to placebo, for 26 weeks plus 6 weeks of follow-up
- Primary end point: percentage change in body weight at week 26
- Result (trial product estimand): mean reductions of 6.0% to 10.8% across the cagrilintide groups, against 3.0% with placebo; the strongest cagrilintide group reached 10.8% against 9.0% with liraglutide
- Adverse events: mostly gastrointestinal, such as nausea, constipation and diarrhoea; gastrointestinal events were reported in 41% to 63% of the cagrilintide groups against 32% with placebo
- Discontinuation: 10% of participants stopped the study drug permanently, at similar rates across groups
The authors reported similar results with the treatment-policy estimand, which counts all randomised participants whatever their adherence.
Cagrilintide-only arms inside the combination trials
Several CagriSema trials also randomised some participants to cagrilintide alone, so that the combination could be compared with each component. In REDEFINE 1, 302 of the 3,417 randomised adults were assigned to cagrilintide alone (Garvey et al., 2025, PubMed). The abstract reports the combination against placebo (−20.4% versus −3.0% at week 68); the single-component arms are reported in the full paper.
A 2026 meta-analysis that pooled four randomised trials reported a mean difference in body weight of −6.08% for cagrilintide alone against placebo, with substantial heterogeneity across most outcomes (Yaseen et al., 2026, PubMed). Pooled figures mix trials of different lengths and populations, so they are a rough summary rather than a single estimate.
The RENEW phase 3 trials
ClinicalTrials.gov lists three Novo Nordisk phase 3 trials of cagrilintide without semaglutide under the RENEW name. All three are placebo-controlled.
- RENEW 1 (NCT07220642): adults with overweight or obesity; primary end point is relative change in body weight from week 0 to week 64; an estimated 300 participants; started 5 November 2025; status "active, not recruiting"; primary completion estimated for May 2027
- RENEW 2 (NCT07220759): adults with overweight or obesity and type 2 diabetes; same 64-week primary end point; an estimated 330 participants; started 5 November 2025; primary completion estimated for May 2027
- RENEW 4 (NCT07745504): compares two presentations (device versions) of cagrilintide with placebo over 26 weeks; an estimated 285 participants; recruiting since August 2026
These records describe planned designs. Estimated dates and enrolment figures in a registry can change.
Pharmacokinetics in renal and hepatic impairment
Two single-administration studies published in 2026 compared cagrilintide exposure in adults with normal, mildly, moderately or severely reduced kidney function (33 participants) or liver function (32 participants). Total exposure and peak concentrations were similar across groups, and no serious adverse events were reported; the authors note the small sample sizes (Nielsen et al., 2026, PubMed).
Preclinical combination work
Cagrilintide is also used as a research tool in combination studies. A September 2026 paper in Nature Metabolism reported combining it with retatrutide in obese male rats (Petersen et al., 2026, PubMed). Rat findings do not establish effects in people.
Limitations
- Duration: the only published trial of cagrilintide on its own ran 26 weeks; the 64-week RENEW results are not yet available
- Sponsor: the phase 2 trial, the RENEW trials and the pharmacokinetic studies are funded by Novo Nordisk, with company employees among the authors
- Estimands: the headline phase 2 figures use the trial product estimand, which assumes participants stayed on the study drug
- Comparisons: results from different trials and compounds are not directly comparable because designs and populations differ
Key terms
- Amylin: a peptide hormone released by pancreatic beta cells together with insulin
- Amylin analogue: a modified version of amylin designed to be more stable or longer acting
- Lipidation: attaching a fatty-acid chain to a peptide, which lets it bind albumin and extends its half-life
- Trial product estimand: an analysis that estimates the effect if all participants had stayed on the study drug
- Treatment-policy estimand: an analysis that includes every randomised participant regardless of whether they stopped the study drug
Supplier
Purita is a store that sells peptides for laboratory research use only. When we checked on 31 October 2026 it did not have a cagrilintide product page; the link below goes to the store's homepage.
Affiliate disclosure: this is a paid link. KlowSignal earns a commission if a purchase is made through it, at no extra cost to the buyer. A listing is not an endorsement or a statement about product quality. See the affiliate disclosure.
Related pages
- Research peptide signals: studies and regulatory updates
- About KlowSignal
- How to read a research or regulatory signal
- CagriSema phase 3: what the REDEFINE trials have reported so far
- Eloralintide: the amylin agonist's phase 2 data and phase 3 trials
- Zenagamtide (amycretin): the phase 2 papers and the AMAZE phase 3 trials
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