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Pipeline › cagrilintide

cagrilintide

Not FDA-approved, and in phase 3 development, not authorised in the European Union. 2 active trials, the next due to complete 2027-05-11.

amylin (+GLP-1) agonist, SC, from Novo Nordisk. Every figure below is taken directly from ClinicalTrials.gov, Drugs@FDA, the FDA Drug Shortage Database, the EMA register or Europe PMC, and re-checked every four hours.

Status
phase3
Target
amylin (+GLP-1)
Route
SC
Sponsor
Novo Nordisk
Brand names
Cagrisema
First FDA approval
Not approved
EU authorisation
Not authorised
Active trials
2 (2 in phase 3)
Participants enrolled
630
Trials with a reporting date
2
Approved FDA submissions
0

When these trials report

12Q3 26: 0 trials reportingQ4 26: 0 trials reportingQ1 27: 0 trials reportingQ2 27: 2 trials reporting, 2 phase 3Q3 27: 0 trials reportingQ4 27: 0 trials reportingQ1 28: 0 trials reportingQ2 28: 0 trials reportingQ3 26Q4 26Q1 272Q2 27Q3 27Q4 27Q1 28Q2 28
When trials are due to report, by quarter — hover a bar for the count. These dates are filed by the sponsor and often move.

Next 2 of 2 active trials by estimated primary completion.

Est. completionTrialSponsorPhaseParticipants
2027-05-11Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide
NCT07220642 · Relative change in body weight
Novo Nordisk A/SP3300
2027-05-12Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide
NCT07220759 · Relative change in body weight
Novo Nordisk A/SP3330

Indications under study

Obesity; Overweight; Type 2 Diabetes.

Recent papers

PublishedTitleJournal
2026-07-13Amylin-based obesity therapy: a meta-analysis of Cagrilintide and CagriSema versus placebo
Yaseen M, Ameer A, Ali Z, Jamali JA, Kumar A, Basit Ali Siddiqui M, Kumari P, Hassaan M, Nanwani P, Abdul Basit M, Lohana N, Qureshi R, Tesfaye M.
Ann Med Surg (Lond)
2026-07-01Comparative Effectiveness of CagriSegma, Semaglutide, Cagrilintide and Tirzepatide in the Management of Overweight and Obesity: A Network Meta-Analysis of Randomized Clinical Trials
Hamarsheh S, Jaber AR, Abu-Khazneh O, Andonie CR, Majadleh S, Zahran A, Ayesh H.
Endocrinol Diabetes Metab
2026-06-08A cross-species atlas of the dorsal vagal complex reveals neural mediators of the effects of cagrilintide on energy balance
Ludwig MQ, Coester B, Gordian D, Hassan S, Tomlinson AJ, Toure MH, Christensen OP, Lommi G, Moltke-Prehn A, Brown JM, Belmont-Rausch DM, Bau S, Bodur C, Gowda A, Wu I, Kernodle S, Dong V, Ayensu-Mensah M, Sabatini PV, Shin JH, Kirigiti M, Egerod KL, Le Foll C, Lundh S, Gerstenberg MK, Lutz TA, Kievit P, Secher A, Raun K, Myers MG, Pers TH.
Nat Metab
2026-06-07Efficacy and safety of once-weekly cagrilintide-semaglutide (CagriSema) in adults with type 2 diabetes inadequately controlled on diet and exercise (REIMAGINE 1): a randomised, double-blind, placebo-controlled, phase 3a study
Aroda VR, Buzzetti R, Dalskov SM, Jain AB, Larsen JH, Mathieu C, Pratley RE, Videmark A, Watt T, Buse JB.
Lancet Diabetes Endocrinol
2026-06-07Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study
Buse JB, Bajaj HS, Dalskov SM, Donaldson L, Hansen Duus HH, Fabricius TW, Haluzík M, Lingvay I, Pedersen SD, Pratley RE, Jain AB, REIMAGINE 2 study group.
Lancet Diabetes Endocrinol
2026-06-07Cagrilintide-semaglutide: a new option for patients with type 2 diabetes
Scheen AJ.
Lancet Diabetes Endocrinol
2026-06-07Cagrilintide-semaglutide (CagriSema) as an add-on to basal insulin in adults with type 2 diabetes (REIMAGINE 3): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study
Rosenstock J, Billings LK, Gajria R, Giorgino F, Johansen NB, Klein KR, Thamattoor UK, Buse JB, Jain AB.
Lancet
2026-06-01Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide
Nielsen MJF, Becker NP, Duus HHH, Kirkeby K, Kupčová V, Lauenborg BW, Low B, Svolgaard O, Witten L.
Clin Pharmacokinet
2026-06-01Cellular loci for cagrilintide action identified
Hevesi Z, Harkany T.
Nat Metab
2026-05-20Cagrilintide and CagriSema for weight reduction and metabolic risk modification in overweight or obesity: a systematic review and meta-analysis
Rao H, Kumar S, Ali SME, Asif HM, Kumar M, Kumar L, Raja A.
J Diabetes Metab Disord
2026-04-17Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5): a multicentre, randomised, active-controlled, phase 3a trial
Yamauchi T, Becker NP, Hagemann CA, Huang KC, Kiyosue A, Lim S, Onishi Y, Kosuvaripalli A, Takano T, Ishigaki Y, REDEFINE 5 study group.
Lancet Diabetes Endocrinol
2026-03-16Efficacy and Safety of Cagrilintide and Cagrisema Versus Semaglutide as Anti-Obesity Medications: A Systematic Review, Meta-Analysis and Meta-Regression
Ahmed M, Hassan M, Tahir M, Hussain M, Islam F, Khan GT, Ahsan M, Bin Shafiq S, Ibrahim A, Uddin A, Waqas SA.
Diabetes Obes Metab
2025-11-01Cagrilintide-Semaglutide in Adults with Overweight or Obesity. Reply
Davies MJ, Broholm C, Garvey WT.
N Engl J Med
2025-10-07In adults with overweight or obesity, weekly subcutaneous cagrilintide-semaglutide increased weight loss at 68 wk
Agarwal A, Padwal R, ACP Journal Club Editorial Team at McMaster University.
Ann Intern Med
2025-08-22Structural and mechanistic insights into dual activation of cagrilintide in amylin and calcitonin receptors
Gu YM, Yuan QN, Li X, He Q, Xu HE, Zhao LH.
Acta Pharmacol Sin

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