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Cag5.0
Cagrilintide – Forschung
Überwiegend Mechanismus / Beobachtung
20 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu Cagrilintide sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus hochwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 2021–2026 mit einer typischen Studiengröße von 706 Teilnehmenden.
Basierend auf 20 Studien · 2 Meta-Analysen · 8 RCTs · 19,304 Teilnehmende insgesamt
Konfidenz
Hohe Konfidenz
Nach Outcome
Weight managementIn einer 26-wöchigen Phase-2-Studie führte Cagrilintide zu einem mittleren Gewichtsverlust von ~6,0-10,8 % gegenüber 3,0 % unter Placebo (am besten bei 4,5 mg) · Über ~26 Wochen
Überwiegend Mechanismus / Beobachtung18 Studien
Safety profile
Überwiegend Mechanismus / Beobachtung7 Studien
Glucose & glycemic controlIn einer Phase-2-Studie bei Typ-2-Diabetes senkte Cagrilintide allein den HbA1c über 32 Wochen um ~0,9 Prozentpunkte · Über ~32 Wochen
Überwiegend Mechanismus / Beobachtung6 Studien
Aktives Forschungsgebiet
20 Studien in den letzten 5 Jahren · Neueste Meta-Analyse: 2024
20212026
1Systematische Übersichtn=511 · large study2026
Primary funding source American College of Physicians. (PROSPERO: CRD42023491646).
Damen JAA, Idema DL, Vernooij RWM, Huis In 't Veld LF, Kusters MPT, Lokerse ME, de Kanter E, Spijker R, van der Braak K, Jenniskens K, Oerbekke MS, Hooft L. · Annals of internal medicine (2026)
Limitation Direct head-to-head comparisons of different treatments were limited.
Conclusion Nearly all studied interventions were more effective than placebo and/or LI in reducing weight.
Semaglutide and tirzepatide showed the most favorable results across outcomes.
The estimated mean percent change in body weight from baseline to week 68 was -20.4% with cagrilintide-semaglutide as compared with -3.0% with placebo (estimated difference, -17.3 percentage points...).
Garvey WT, Blüher M, Osorto Contreras CK, Davies MJ, Winning Lehmann E, Pietiläinen KH, Rubino D, Sbraccia P, Wadden T, Zeuthen N, Wilding JPH. · N Engl J Med (2025)
Pivotal phase-3a (REDEFINE 1), 68-week, double-blind, placebo- and active-controlled trial in 3,417 adults without diabetes (BMI >=30, or >=27 with a complication); CagriSema vs semaglutide alone vs cagrilintide alone vs placebo (all 2.4 mg)
CagriSema produced -20.4% mean weight loss vs -3.0% placebo at week 68 (difference -17.3 percentage points); also superior to semaglutide and cagrilintide monotherapy arms
Includes a 302-participant cagrilintide-monotherapy arm — the largest standalone-cagrilintide dataset to date
The estimated mean change in body weight from baseline to week 68 was -13.7% in the cagrilintide-semaglutide group and -3.4% in the placebo group (estimated difference, -10.4 percentage points...).
Davies MJ, Bajaj HS, Broholm C, Eliasen A, Garvey WT, le Roux CW, Lingvay I, Lyndgaard CB, Rosenstock J, Pedersen SD. · N Engl J Med (2025)
Pivotal phase-3a (REDEFINE 2), 68-week, double-blind, placebo-controlled trial in 1,206 adults with overweight/obesity and type 2 diabetes (BMI >=27, HbA1c 7-10%); once-weekly CagriSema 2.4 mg each vs placebo
CagriSema produced -13.7% mean weight loss vs -3.4% placebo at week 68 (difference -10.4 percentage points)
73.5% of the CagriSema group reached HbA1c <=6.5% vs 15.9% placebo
The proportion of participants reaching BP targets at week 68 was 63.0% and 32.0% for CagriSema and placebo, respectively.
The proportion of participants with resistant hypertension at baseline (n=167) that reached BP targets at week 68 was 42.0% and 29.3% for CagriSema and placebo, respectively (odds ratio, 1.7 [95% CI, 0.7-4.4]).
Among participants who used antihypertensive medication during the study, 39.6% in the CagriSema group decreased or stopped treatment from week 0 to week 68 versus 18.8% with placebo.
A better understanding of the mechanisms underlying potential neuroprotection will be essential to determine whether these therapies can be effectively integrated into stroke management strategies.
Paceana MA, Tartau LM, Boboc IKS, Oancea CN, Berbecaru-Iovan A, Foia CI, Tartau CG, Bogdan M. · Pharmaceutics (2026)
Overall, GLP-1 RAs should currently be regarded primarily as agents for long-term vascular risk reduction rather than established therapies for acute stroke.
While potential neuroprotective effects are emerging, these require confirmation in adequately powered randomized trials.
Future studies should aim to identify the patient subgroups most likely to benefit and to determine whether specific agents confer advantages in acute cerebrovascular contexts.
6Systematische Übersichtn=4,642 · very large study2026
The review protocol summary can be accessed at the PROSPERO website (https://www.crd.york.ac.uk/PROSPERO/view/CRD420261340457).
Kamrul-Hasan ABM, Khalil I, Mahajan K, Dutta D, Banerjee M, Pappachan JM. · Endocrinology, diabetes & metabolism (2026)
Primary outcome was the percent change in body weight from baseline.
Only HiD CagriSema increased AE-related discontinuation.
Conclusions Novel ABTs, such as HiD amycretin, CagriSema and eloralintide, may induce substantial short- to medium-term weight loss but may also increase GI AEs; given sparse, low-certainty data, these findings are preliminary and require confirmation in larger trials.
Cagrilintide-semaglutide at doses of 2·4 mg each and 1·0 mg each met the primary endpoint, with statistically significant and clinically relevant HbA1c reductions versus placebo when added to basal insulin-treated type 2 diabetes.
Rosenstock J et al. · Lancet (London, England) (2026)
Cagrilintide-semaglutide at doses of 2·4 mg each and 1·0 mg each met the primary endpoint, with statistically significant and clinically relevant HbA1c reductions versus placebo when added to basal insulin-treated type 2 diabetes.
These reductions were accompanied by robust bodyweight reduction and no additional risk of hypoglycaemia.
The safety profile was consistent with that of the GLP-1 receptor agonist class and previous safety data for cagrilintide.
8Systematische Übersichtn=5,023 · very large study2026
Supplementary information The online version contains supplementary material available at 10.1007/s40200-026-01942-3.
Rao H, Kumar S, Ali SME, Asif HM, Kumar M, Kumar L, Raja A. · Journal of diabetes and metabolic disorders (2026)
The primary outcome was percent change in body weight.
Cagrilintide significantly reduced percent body weight versus placebo (mean difference - 6.08%, 95% CI - 8.02 to - 4.14), as did CagriSema (- 5.98%, 95% CI - 10.64 to - 1.32).
Both interventions significantly reduced absolute body weight.
The aim of the review is to acquaint the reader with developments in the field from 2023 to the present (February 2025).
Bailey CJ, Flatt PR, Conlon JM. · Peptides (2025)
Emerging evidence suggests that incretin therapies could additionally ameliorate fatty liver disease, chronic inflammation, sleep apnea and possibly degenerative bone disorders and cognitive decline.
The creation of multi-targeting incretin-based synthetic peptides provides opportunities for improved management of type 2 diabetes and obesity as well as new therapeutic approaches to an expanding list of associated co-morbidities.
The aim of the review is to acquaint the reader with developments in the field from 2023 to the present (February 2025).
Such insight will also be important to understand how amylin and sCT analogues synergize with other molecules as part of dual or triple agonist therapies for obesity, especially the glucagon-like peptide 1 receptor (GLP-1R) agonist semaglutide, which has been shown to synergistically lower body weight with cagrilintide (CagriSema) in clinical trials.
Hankir MK, Le Foll C. · Biochimie (2025)
While the caudal hindbrain was originally implicated as a major site of action in this regard, it is becoming increasingly clear that amylin recruits numerous central nervous system pathways to exert multifaceted effects on food intake.
In this review, we will examine the efficacy and safety of the drugs marketed and others under ongoing clinical trials for the treatment of persons with obesity, as well as the main challenges faced by both healthcare professionals and patients in maintaining long-term treatment.
Rubio-Herrera MA, Mera-Carreiro S. · Medicina clinica (2025)
Beyond the necessary lifestyle changes, this new era with second-generation drugs has been able to achieve weight loss of 15-25%, close to that of bariatric surgery.
Glucagon-like peptide-1 (GLP-1) receptor agonists (RA), used as weekly injectable monotherapy or daily oral (semaglutide), achieve weight loss of 15-17%, with a good safety profile.
Tirzepatide (a dual GLP-1/GIP receptor agonist) achieves weight loss of up to 22.5% at the highest doses.
Further research is needed to improve our understanding of their effects on obesity-related comorbidities and the underlying mechanism, whether involving direct effects on target tissues or mediated by improvement in BW, glucose levels and other CV risk factors.
Caruso I, Cignarelli A, Sorice GP, Perrini S, Giorgino F. · npj metabolic health and disease (2024)
Obesity-related disability-adjusted life years (DALYs) are expected to increase by approximately 40% from 2020 to 2030.
Incretin-based therapies have been associated with a body weight (BW) reduction of ≥5% in at least half of patients in most randomized controlled trials (RCT) and real-world studies (RWS).
Semaglutide and tirzepatide have also displayed a mean 60-69% 10-years relative risk reduction of T2D development.
Mean percentage weight reductions from baseline were greater with all doses of cagrilintide (0·3-4·5 mg, 6·0%-10·8%) versus placebo (3·0%)... Weight reductions were also greater with cagrilintide 4·5 mg versus liraglutide 3·0 mg (10·8% vs 9·0%).
Lau DCW, Erichsen L, Francisco AM, Satylganova A, le Roux CW, McGowan B, Pedersen SD, Pietiläinen KH, Rubino D, Batterham RL. · Lancet (2021)
Phase-2, double-blind, randomised, placebo- and active-controlled dose-finding trial across 57 sites in ten countries; 706 adults with overweight/obesity (no diabetes) on once-weekly subcutaneous cagrilintide 0.3-4.5 mg vs liraglutide 3.0 mg vs placebo over 26 weeks
Mean weight loss ranged 6.0-10.8% across cagrilintide doses vs 3.0% placebo; the 4.5 mg dose modestly beat liraglutide 3 mg (10.8% vs 9.0%)
Gastrointestinal disorders (nausea, constipation, diarrhoea) and administration-site reactions were the most frequent adverse events; GI events 41-63% across doses vs 32% placebo
The mean change in bodyweight from baseline to week 32 (CagriSema: -15·6%; semaglutide: -5·1%; cagrilintide: -8·1%) was greater with CagriSema versus both semaglutide and cagrilintide.
Phase-2, double-blind, active-controlled trial in 92 adults with type 2 diabetes on metformin ± SGLT2 inhibitor; once-weekly CagriSema vs semaglutide vs cagrilintide (all escalated to 2.4 mg) over 32 weeks
Cagrilintide monotherapy lowered weight and HbA1c less than the combination; mild/moderate GI events were most common, with no level 2-3 hypoglycaemia and no fatal events
At week 20, mean percentage bodyweight reductions were greater with cagrilintide 1·2 and 2·4 mg than with placebo (15·7% for cagrilintide 1·2 mg and 17·1% for cagrilintide 2·4 mg vs 9·8% for pooled placebo)... all in combination with semaglutide 2·4 mg.
Enebo LB, Berthelsen KK, Kankam M, Lund MT, Rubino DM, Satylganova A, Lau DCW. · Lancet (2021)
Phase-1b, randomised, placebo-controlled, multiple-ascending-dose trial in 95 treated adults with overweight/obesity; once-weekly subcutaneous cagrilintide 0.16-4.5 mg co-administered with semaglutide 2.4 mg over 20 weeks
Proof of concept for the CagriSema combination: ~15-17% weight loss at the 1.2/2.4 mg doses vs ~9.8% pooled placebo (all with semaglutide)
Cagrilintide half-life 159-195 h; exposure proportional to dose and did not affect semaglutide exposure; 37% of adverse events were GI disorders, most mild-to-moderate
Cagrilintide did not result in clinically relevant QTcF prolongation, indicating no increased risk of ventricular tachyarrhythmias.
Gabe MBN, Fuhr R, Sinn A, Eliasen A, Berthelsen KK, Kuhlman AB, Bækdal TA, Nejad AB. · Diabetes Obes Metab (2024)
Double-blind thorough-QT study in 105 healthy participants randomised to once-weekly subcutaneous cagrilintide escalated to 4.5 mg or placebo, with oral moxifloxacin as a positive control
No clinically relevant QTcF prolongation after the 4.5 mg dose — upper 90% CI limits below 10 ms at all timepoints
QT assay sensitivity confirmed via moxifloxacin positive control
Cagrisema outperforms semaglutide regarding weight loss. Cagrilintide shows comparable weight loss to semaglutide/liraglutide with significantly lower vomiting.
Dutta D, Nagendra L, Harish BG, Sharma M, Joshi A, Hathur B, Kamrul-Hasan A. · Indian J Endocrinol Metab (2024)
Systematic review and meta-analysis of 3 RCTs (430 individuals) of cagrilintide alone or as CagriSema vs placebo/active comparator
CagriSema gave significantly greater weight loss than semaglutide 2.4 mg (mean difference -9.07%); cagrilintide 2.4 mg alone was comparable to semaglutide/liraglutide (-1.83%, non-significant)
GI adverse events and vomiting were higher with CagriSema than semaglutide; vomiting was significantly lower with cagrilintide than semaglutide/liraglutide
We report here the development of the stable, lipidated long-acting amylin analogue cagrilintide... Cagrilintide is currently in clinical trial and has induced significant weight loss when dosed alone or in combination with the GLP-1 analogue semaglutide.
Kruse T, Hansen JL, Dahl K, Schäffer L, Sensfuss U, Poulsen C, Schlein M, Hansen AMK, Jeppesen CB, Dornonville de la Cour C, Clausen TR, Johansson E, Fulle S, Skyggebjerg RB, Raun K. · J Med Chem (2021)
Medicinal-chemistry discovery paper from Novo Nordisk describing the design of cagrilintide to overcome amylin's amyloid-fibril aggregation and short half-life
Cagrilintide was engineered as a stable, lipidated long-acting amylin analogue selected for clinical development in obesity
Notes significant weight loss when dosed alone or with semaglutide in early clinical work
Cagrilintide alone, as well as cagrilintide in combination with semaglutide have shown promising weight loss in clinical trials that supports the further development of this therapy for sustained weight management.