Evidence Grade C — Moderate human evidence. 77 published studies, 48 human. 42 registered clinical trials.
Medically reviewed by a licensed medical professional
Cagrilintide is a long-acting amylin analogue from Novo Nordisk — targeting a different satiety pathway than GLP-1 drugs like semaglutide. While it produces meaningful weight loss on its own (about 12%), its primary strategic value is as the amylin component of CagriSema, a combination with semaglutide designed to achieve greater weight loss than either drug alone.
Cagrilintide is also known by these brand and alternate names:
77 published studies: 48 human, 3 animal, 5 in-vitro, 40 reviews
Cagrilintide is in Phase III development (not yet approved). In a Phase II trial (706 patients), cagrilintide 4.5 mg achieved 10.8% weight loss, outperforming the active comparator liraglutide 3.0 mg (9.0%). Phase III results (REDEFINE-1) showed 11.8% weight loss as monotherapy.
Cagrilintide's primary strategic significance is as the amylin component of CagriSema (#162). As a standalone agent, its weight loss is less than currently available GLP-1 agonists like semaglutide. Its value lies in the complementary mechanism that produces additive effects when combined with semaglutide.
Cagrilintide activates amylin receptors in the brain, promoting satiety through a pathway that is complementary to but distinct from GLP-1. While GLP-1 drugs primarily affect appetite and gastric emptying, amylin signalling acts on both the homeostatic (energy balance) and hedonic (reward-based) feeding centres. This dual-centre suppression of food intake may explain the additive weight loss observed when amylin is combined with GLP-1 agonists.
In a Phase II trial of 706 patients, the highest dose of cagrilintide achieved 10.8% weight loss, outperforming the active comparator liraglutide (9.0%). Phase III monotherapy results (REDEFINE-1) showed 11.8% weight loss — meaningful but less than currently available GLP-1 treatments like semaglutide. Cagrilintide's true potential lies in combination. By targeting the amylin pathway alongside GLP-1, it adds a complementary mechanism that amplifies weight loss beyond what either pathway achieves alone. The Phase III monotherapy programme (RENEW) was initiated in late 2025. Injection-site reactions occur in about 17% of patients. No regulatory filing for cagrilintide as a standalone treatment has been made, and approval is unlikely before 2028.
PeptideTrace tracks 42 registered clinical trials for Cagrilintide sourced from ClinicalTrials.gov.
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events
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 Weight
Cagrilintide (AM833/NN0174) is a long-acting acylated human amylin analog peptide developed by Novo Nordisk for obesity treatment. The 37-amino-acid peptide has a molecular weight of approximately 4,409 Da and molecular formula C194H312N54O59S2. A C20 fatty diacid moiety linked via gamma-glutamic acid enables reversible albumin binding, producing a half-life of 159-195 hours (approximately 7 days) suitable for once-weekly subcutaneous injection. CAS number: 1415456-99-3. Cagrilintide represents Novo Nordisk's amylin-based approach to obesity pharmacotherapy, serving both as a standalone candidate and as one half of the CagriSema combination therapy.
Cagrilintide is a nonselective agonist of amylin receptors AMY1R (CTR+RAMP1) and AMY3R (CTR+RAMP3), as well as the calcitonin receptor (CTR), with binding IC50 values of 170 pM at human AMY3R and 223 pM at human CTR. The compound suppresses appetite through dual action on both homeostatic hypothalamic pathways and hedonic reward center circuits in the brain. Additional pharmacological effects include slowing of gastric emptying and suppression of postprandial glucagon secretion, contributing to improved glycemic control alongside weight reduction.
In the Phase 2 dose-finding trial (Lau et al., Lancet 2021; NCT03856047; N=706), cagrilintide 4.5 mg achieved -10.8% weight loss versus -3.0% with placebo (estimated treatment difference -7.8 percentage points; P<0.001), outperforming the active comparator liraglutide 3.0 mg which produced -9.0% weight loss. In the REDEFINE-1 Phase 3 trial monotherapy arm (N=302), cagrilintide 2.4 mg delivered -11.8% weight loss at 68 weeks (trial product estimand) compared with -2.3% for placebo. Novo Nordisk has initiated the dedicated RENEW Phase 3 monotherapy program. Key safety signals include gastrointestinal events (nausea, constipation) and injection-site reactions affecting approximately 17% of participants in the REDEFINE-1 monotherapy arm.
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Semaglutide is one of the most extensively studied peptide medications available today, with clinical trial data spanning over 50,000 patients. It is sold as Ozempic for type 2 diabetes (approved 2017), Rybelsus as an oral tablet for diabetes (approved 2019), and Wegovy for weight management (approved 2021). Wegovy has since received additional approvals for reducing heart attack and stroke risk, for use in adolescents aged 12 and older, and for liver disease related to obesity. In clinical trials, patients taking Wegovy lost an average of 14.9% of their body weight over 68 weeks, and the SELECT trial demonstrated a 20% reduction in major cardiovascular events such as heart attack and stroke. Research is now exploring its potential in early Alzheimer's disease. The main side effects are gastrointestinal, particularly nausea, and a key limitation is that most weight tends to return after stopping treatment.
Bimagrumab is in Phase II/III development (not yet approved). A Phase II trial (75 patients with type 2 diabetes and obesity) showed 20.5% fat mass reduction with 3.6% lean mass increase — essentially reshaping body composition without net appetite suppression. The BELIEVE Phase IIb trial (507 patients) showed that bimagrumab plus semaglutide achieved 22% weight loss with the weight lost being 88% fat — significantly better body composition than semaglutide alone. Bimagrumab is not a peptide. Its strategic significance is as a combination partner to address the muscle loss problem inherent in weight loss with current obesity drugs. Eli Lilly's acquisition positions it alongside tirzepatide.
Pemvidutide is in Phase II/III development (not yet approved). In the MOMENTUM Phase II trial (391 patients, 48 weeks), the 2.4 mg dose achieved 15.6% weight loss. Body composition analysis showed 78% of weight lost was fat mass, with only 22% lean mass — a favourable ratio. A Phase IIb MASH trial (212 patients) showed MASH resolution in up to 75% of patients at the highest dose. Pemvidutide's balanced receptor profile and no-titration dosing regimen represent potential practical advantages. The high rate of MASH resolution in Phase II positions it as a candidate for liver disease indications alongside obesity.
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