Also known as cagrilintide, CagriSema, AM833, NNC0174-0833.
Cagrilintide is a long-acting amylin analogue studied as a once-weekly subcutaneous injection for weight management, alone and coformulated with semaglutide as CagriSema. A phase 2 dose-finding trial reported greater weight loss than placebo, and phase 3 REDEFINE and REIMAGINE trials reported large weight and HbA1c reductions with the combination. Gastrointestinal adverse events were common. Cagrilintide is not an FDA-approved drug.
Peptide15 human studies
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Regulatory status in the United States
Status reviewed September 16, 2026
FDA-approved drug
No. Cagrilintide is not an FDA-approved drug for any use.
503A compounding
Not on FDA's 503A lists. Not nominated for, or not currently on, FDA's list of bulk drug substances permitted for 503A compounding.
How it is obtained
Sold only as a research chemical labeled “not for human use.” No lawful prescription pathway exists for it today.
Cagrilintide is not an FDA-approved drug for any use. It is not on FDA's 503A bulk drug substances lists, and no lawful prescription pathway for a compounded version was identified at the review date. Products sold as "research use only" are not intended for human use and are not a lawful substitute for a prescription. This status comes from the site's regulatory review, not from the studies cited on this page.
What Cagrilintide is
Cagrilintide, also written as AM833 or NNC0174-0833, is a long-acting analogue of amylin, the pancreatic hormone co-secreted with insulin from beta cells in response to food that induces satiety and reduces body weight (Cardiology in Review, 2023; Amylin review, 2024). It has been developed by Novo Nordisk for weight management, both as a single agent and in combination with the GLP-1 receptor agonist semaglutide, a pairing referred to in the literature as CagriSema (Cardiology in Review, 2023). Cagrilintide is not an FDA-approved drug.
Most of the published human data sit in two buckets. The first is a phase 2 dose-finding trial of once-weekly cagrilintide alone in adults with overweight or obesity without diabetes, which reported greater weight reductions than placebo across the doses tested over 26 weeks (Lancet dose-finding trial, 2021). The second, and much larger, is the phase 3 programme of the cagrilintide-semaglutide combination, including REDEFINE 1 in adults with overweight or obesity (REDEFINE 1, 2025), REDEFINE 2 in adults with type 2 diabetes (REDEFINE 2, 2025), and REIMAGINE 1 in early-stage type 2 diabetes managed with diet and exercise (REIMAGINE 1, 2026).
Because the combination has been the development focus, reviews and network meta-analyses generally discuss cagrilintide in the context of CagriSema rather than as a stand-alone therapy (Pipeline review, 2024; Emerging pharmacotherapies systematic review, 2024). A network meta-analysis of GLP-1 based drugs in type 2 diabetes ranked CagriSema highest for weight loss among the agents compared (BMJ network meta-analysis, 2024), and a later network meta-analysis in adults without diabetes placed it behind retatrutide and tirzepatide on percentage weight loss (BMJ Medicine network meta-analysis, 2026).
Several registered studies are still filling in mechanistic and safety detail rather than efficacy: a completed phase 1 study of how CagriSema affects appetite, energy intake and brain mechanisms (NCT06267092), a completed pharmacokinetic study comparing combined versus separate cagrilintide and semaglutide injections (NCT04940078), and a recruiting study of cagrilintide, semaglutide, CagriSema or placebo on bone metabolism in postmenopausal women with obesity during weight loss (NCT07010432). Results for these are not part of the fetched published record.
How it is thought to work
Amylin is described as a neuroendocrine anorexigenic polypeptide hormone co-secreted with insulin from pancreatic beta cells in response to food. Beyond its effect on glucose homeostasis, amylin inhibits homeostatic and hedonic feeding, induces satiety and decreases body weight (Amylin review, 2024). Cagrilintide is a long-acting analogue designed around that biology, and it has been characterised alongside pramlintide as an amylin-based approach to obesity and so-called diabesity (Amylin review, 2024).
Amylin released with insulin induces its satiating effect via both homeostatic and hedonic regions of the brain, while semaglutide reduces appetite via GLP-1 receptors in the hypothalamus, increases insulin production, reduces glucagon secretion and delays gastric emptying. These separate but related mechanisms are reported to have an additive effect on appetite reduction, which is the stated rationale for combining an amylin analogue with a GLP-1 receptor agonist (Cardiology in Review, 2023).
Reviews of the obesity pipeline frame cagrilintide as one of several entero-pancreatic hormone analogues being combined with GLP-1 agonism to push weight loss beyond what GLP-1 receptor agonists achieve alone, alongside GIP and glucagon based co-agonists (Pipeline review, 2024; Weight management review, 2025). The pharmacokinetic rationale for weekly administration is reflected in trial designs that use stepwise dose escalation before a maintenance dose (NCT04940078; NCT07010432).
A mechanistic human study registered as NCT06267092 was designed to measure appetite, energy intake and brain activity associated with appetite and food intake during CagriSema treatment versus placebo, with a dose-escalation period followed by an intervention period including a standardised energy intake period. The registration describes the design only; no outcome data for that study appear in the fetched sources.
What the research shows
The dose-finding evidence for cagrilintide alone comes from a multicentre, randomised, double-blind, placebo-controlled and active-controlled phase 2 trial at 57 sites in ten countries, enrolling adults without diabetes with a body-mass index of at least 30 kg/m2, or at least 27 kg/m2 with hypertension or dyslipidaemia. Over a 26-week treatment period, mean percentage weight reductions were greater with all cagrilintide doses tested than with placebo, and greater with the highest cagrilintide dose than with once-daily liraglutide. Treatment was described as well tolerated (Lancet dose-finding trial, 2021).
The largest published trial is REDEFINE 1, a 68-week phase 3a trial in 3417 adults without diabetes randomised to cagrilintide-semaglutide, semaglutide alone, cagrilintide alone or placebo. Estimated mean percent change in body weight to week 68 was -20.4% with cagrilintide-semaglutide versus -3.0% with placebo (estimated difference -17.3 percentage points). The abstract does not report the weight change for the cagrilintide-alone arm (REDEFINE 1, 2025). In REDEFINE 2, 1206 adults with type 2 diabetes and a BMI of 27 or more had an estimated mean weight change of -13.7% with cagrilintide-semaglutide versus -3.4% with placebo, and 73.5% versus 15.9% reached an HbA1c of 6.5% or less (REDEFINE 2, 2025).
In REIMAGINE 1, a phase 3a trial in 189 adults with type 2 diabetes inadequately controlled with diet and exercise, two dose levels of cagrilintide-semaglutide were superior to placebo for HbA1c change at week 40 and for relative change in body weight, with a safety profile the authors described as consistent with the GLP-1 receptor agonist class and with previous cagrilintide safety data (REIMAGINE 1, 2026). Pooled analyses agree on direction: a meta-analysis of seven randomised trials reported greater weight loss with CagriSema than with semaglutide, cagrilintide or placebo, with adverse events primarily gastrointestinal and injection-site related and no increase in serious adverse events (CagriSema meta-analysis, 2026).
The gaps are specific. Long-term outcome data for cagrilintide as monotherapy are not represented in the fetched sources, which discuss it mainly as a component of CagriSema (Pipeline review, 2024; Emerging pharmacotherapies systematic review, 2024). Reviewers note that data on mortality and cardio-renal-metabolic events for emerging obesity agents are still needed (Emerging pharmacotherapies systematic review, 2024), that information on CagriSema in adolescents remains limited compared with adults (Adolescent obesity review, 2026), and that head-to-head evidence and tolerability differences leave residual uncertainty in indirect comparisons (BMJ Medicine network meta-analysis, 2026).
Latest research
No digests yet — the pipeline adds new studies daily.
Study-reported dosing
Doses that cited studies administered to their participants. Reported as research, not recommendations.
Regimen as reported
Population
Route
Source
Cagrilintide alone at a dose of 2.4 mg, or semaglutide at a dose of 2.4 mg combined with cagrilintide at a dose of 2.4 mg, plus lifestyle interventions, over 68 weeksThe trial randomised participants 21:3:3:7 to cagrilintide-semaglutide, semaglutide alone, cagrilintide alone or placebo.
Adults without diabetes with a BMI of 30 or higher, or 27 or higher with at least one obesity-related complication (REDEFINE 1, n=3417)
Once-weekly cagrilintide-semaglutide (2.4 mg each) or placebo, along with lifestyle intervention, for 68 weeksPatients were assigned in a 3:1 ratio to cagrilintide-semaglutide or placebo.
Adults with a body-mass index of 27 or more, a glycated hemoglobin level of 7 to 10%, and type 2 diabetes (REDEFINE 2, n=1206)
Once weekly doses of cagrilintide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. for 2 weeks, given with semaglutide as separate injections or combined in a single injectionRegistration text describing planned administration; the listing does not report results.
People with overweight or obesity enrolled in a completed phase 1 pharmacokinetic study (n=40)
Adverse events, or their absence, as the cited studies recorded them in the populations they enrolled.
Reported effect
Context in the study
Source
Gastrointestinal disorders including nausea, constipation and diarrhoea, plus administration-site reactions
Most frequent adverse events in the phase 2 dose-finding trial of once-weekly cagrilintide alone; more participants on cagrilintide had gastrointestinal adverse events than on placebo (41%-63% vs 32%), primarily nausea (20%-47% vs 18%)
Treatment discontinuation, mostly due to adverse events
Permanent treatment discontinuation occurred in 73 of 706 participants (10%) similarly across treatment groups in the phase 2 trial, mostly due to adverse events (n=30, 4%)
Reported by 79.6% in the cagrilintide-semaglutide group versus 39.9% in the placebo group in REDEFINE 1; mainly transient and mild-to-moderate in severity
Reported by 72.5% of patients on cagrilintide-semaglutide versus 34.4% on placebo in adults with type 2 diabetes (REDEFINE 2); most were transient and mild or moderate in severity
Online programs that list Cagrilintide, as described on their own sites. Whether a prescriber will write for it depends on the regulatory status above and on your state.
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Hone Health
Compounds
sermorelin, nad
Pricing
From $175/month. Published on honehealth.com at check time: sermorelin $175/month; other medications listed at $20 to $199/month plus membership. Membership is $25/month (Basic: labs every 6 months, consults purchased separately) or $155/month (Premium: labs, physician consults and medication access); the initial 50+ biomarker test is $65. State coverage is not stated on the pages we read, so it is recorded here as nationwide until confirmed.
From $99/month. Published on livevital.io at check time: $99 to $299 per month depending on the peptide, sold as 10-week courses. GHK-Cu $99/month; BPC-157 and Wolverine $116/month; Glow, Klow and MOTS-c $149/month; tesamorelin $166/month. The 15-minute phone consult is free and HSA/FSA funds are accepted.io.
From $164/month. Published on joinmidi.com at check time: Midi compounded GLP-1 and GLP-1/GIP from $164 per 4-week supply including shipping and supplies; visits are billed to insurance where in-network or $150 to $250 self-pay; brand-name GLP-1s are sent to a pharmacy of choice at the insurance price. A lower-strength weekly plan is advertised from $34 per week for eligible patients. The GLP-1 page notes that compounded products are not available in every state.
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⚠Research use only — not for human use
Liberty Peptides
Third-party COAs published · Ships to United States
Research vendors sell compounds as chemicals labelled “not for human use.” A listing is not an endorsement and says nothing about purity or legality in your state.
Frequently asked questions
What is cagrilintide?
Cagrilintide is a long-acting amylin analogue under investigation for weight management, developed as a once-weekly injection and also combined with the GLP-1 receptor agonist semaglutide under the name CagriSema (Lancet dose-finding trial, 2021; Cardiology in Review, 2023). Amylin itself is a hormone co-secreted with insulin that induces satiety and reduces body weight (Amylin review, 2024). Cagrilintide is not an FDA-approved drug.
What does the human evidence show for cagrilintide on its own?
The main published stand-alone evidence is a 26-week randomised phase 2 dose-finding trial in adults with overweight or obesity without diabetes. Mean percentage weight reductions were greater with every cagrilintide dose tested than with placebo, and greater with the highest cagrilintide dose than with once-daily liraglutide (Lancet dose-finding trial, 2021). REDEFINE 1 included a cagrilintide-alone arm of 302 participants, but the published abstract reports the weight outcome for the combination versus placebo rather than for that arm (REDEFINE 1, 2025).
How much weight loss was reported with CagriSema?
In REDEFINE 1, estimated mean percent change in body weight at week 68 was -20.4% with cagrilintide-semaglutide versus -3.0% with placebo in adults without diabetes (REDEFINE 1, 2025). In REDEFINE 2, in adults with type 2 diabetes, it was -13.7% versus -3.4% with placebo (REDEFINE 2, 2025). A network meta-analysis in type 2 diabetes ranked CagriSema highest for weight loss at -14.03 kg versus placebo (BMJ network meta-analysis, 2024), and a later analysis in adults without diabetes reported -17.32% versus placebo, behind retatrutide and tirzepatide (BMJ Medicine network meta-analysis, 2026).
How was cagrilintide given in the studies?
Trials used once-weekly subcutaneous administration with stepwise dose escalation before a maintenance period. REDEFINE 1 used cagrilintide alone at a dose of 2.4 mg, or semaglutide 2.4 mg with cagrilintide 2.4 mg, plus lifestyle interventions over 68 weeks (REDEFINE 1, 2025), and REDEFINE 2 used once-weekly cagrilintide-semaglutide (2.4 mg each) for 68 weeks in adults with type 2 diabetes (REDEFINE 2, 2025). A phase 1 pharmacokinetic study describes once-weekly cagrilintide gradually increased to 1.7 mg over 14 weeks and 2.4 mg subcutaneously for 2 weeks (NCT04940078).
What side effects were reported?
Gastrointestinal events dominate. In the phase 2 trial of cagrilintide alone, the most frequent adverse events were gastrointestinal disorders such as nausea, constipation and diarrhoea, plus administration-site reactions, with gastrointestinal events in 41%-63% of cagrilintide groups versus 32% on placebo (Lancet dose-finding trial, 2021). With the combination, gastrointestinal adverse events affected 79.6% versus 39.9% on placebo in REDEFINE 1 (REDEFINE 1, 2025) and 72.5% versus 34.4% in REDEFINE 2, mostly transient and mild or moderate (REDEFINE 2, 2025). A pooled analysis reported no increase in serious adverse events (CagriSema meta-analysis, 2026).
How does cagrilintide differ from semaglutide?
They act on different systems. Cagrilintide is an amylin analogue; amylin induces satiety via homeostatic and hedonic brain regions. Semaglutide is a GLP-1 receptor agonist that reduces appetite via hypothalamic GLP-1 receptors, increases insulin production, reduces glucagon secretion and delays gastric emptying. These mechanisms are described as having an additive effect on appetite reduction (Cardiology in Review, 2023). In pooled trial data, the combination produced greater weight loss than either semaglutide or cagrilintide alone (CagriSema meta-analysis, 2026), and head-to-head data showed greater weight loss with cagrilintide-semaglutide than semaglutide (Annals systematic review, 2026).
Does cagrilintide affect blood sugar?
In REDEFINE 2, 73.5% of patients receiving cagrilintide-semaglutide reached a glycated hemoglobin level of 6.5% or less versus 15.9% on placebo (REDEFINE 2, 2025). In REIMAGINE 1, both tested dose levels of cagrilintide-semaglutide lowered HbA1c significantly more than placebo at week 40 in adults with type 2 diabetes inadequately controlled with diet and exercise (REIMAGINE 1, 2026). A pooled analysis of CagriSema trials described glycemic outcomes as heterogeneous while lipid parameters improved versus placebo (CagriSema meta-analysis, 2026). The fetched sources do not isolate glycaemic effects of cagrilintide alone.
What do the animal or laboratory data show?
The fetched sources are human trials, trial registrations and reviews of human pharmacotherapy. None of them report animal or in-vitro experiments with cagrilintide, so no preclinical findings can be described here. The mechanistic descriptions available come from reviews of amylin physiology and of the amylin analogue class in humans (Amylin review, 2024; Cardiology in Review, 2023).
What is still unknown about cagrilintide?
Long-term outcome data are the main gap. Reviewers note that data on mortality and cardio-renal-metabolic events, and long-term follow-up on safety and weight maintenance, are still needed for emerging obesity pharmacotherapies including CagriSema (Emerging pharmacotherapies systematic review, 2024). Information in adolescents remains limited compared with adults (Adolescent obesity review, 2026). Effects on bone during weight loss are being studied in a recruiting trial comparing cagrilintide, semaglutide, CagriSema and placebo in postmenopausal women with obesity (NCT07010432), and tolerability of switching from semaglutide to CagriSema is the subject of a registered but not-yet-recruiting study (NCT07817251).