CagriSema (Cagrilintide)

Updated 19 Oct 2026 · Peptilex evidence grade B (A = approved, large trials · D = mainly animal studies)

The amylin-plus-semaglutide combination led to 20.4% average weight loss over 68 weeks in REDEFINE 1, and in the 2026 head-to-head trial REDEFINE 5 it reached 18.4% versus 11.9% on semaglutide alone. It was submitted to the FDA in December 2025; a decision is expected in late 2026.

121PubMed papers

76Human studies

15Randomized trials

40Registered studies

17Ongoing / starting

21Phase 3+

Registered trials

From ClinicalTrials.gov, matched by name in the study title.

Study	Phase	Status	Participants	Start
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels NCT05669755 · Novo Nordisk A/S	Phase 3	Running	7,101	2023-03
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight NCT05567796 · Novo Nordisk A/S	Phase 3	Running	3,400	2022-11
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 NCT07564414 · Novo Nordisk A/S	Phase 3	Recruiting	2,500	2026-05
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term NCT07011667 · Novo Nordisk A/S	Phase 3	Running	609	2025-06
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight NCT07253285 · Novo Nordisk A/S	Phase 3	Recruiting	460	2026-01
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity NCT06780449 · Novo Nordisk A/S	Phase 3	Running	400	2025-02
Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide NCT07220759 · Novo Nordisk A/S	Phase 3	Running	330	2025-11
Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide NCT07220642 · Novo Nordisk A/S	Phase 3	Running	300	2025-11
A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight NCT07745504 · Novo Nordisk A/S	Phase 3	Recruiting	285	2026-08
Research Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema NCT07817251 · Novo Nordisk A/S	Phase 3	Recruiting	210	2026-09
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 NCT07282613 · Novo Nordisk A/S	Phase 3	Recruiting	80	2026-08
A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity NCT07597018 · Novo Nordisk A/S	Phase 1	Recruiting	234	2026-05
The Role of the Amylin Analogue Cagrilintide in Bone Metabolism NCT07010432 · Novo Nordisk A/S	Phase 1	Recruiting	144	2025-06
A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity NCT07557953 · Novo Nordisk A/S	Phase 1	Recruiting	120	2026-04
Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events NCT07607587 · Novo Nordisk A/S	Phase 1	Recruiting	114	2026-05
Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health) NCT07527195 · Novo Nordisk A/S	Phase 1	Recruiting	100	2026-04
A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet NCT07184086 · Novo Nordisk A/S	Phase 1	Running	80	2025-09
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor NCT06065540 · Novo Nordisk A/S	Phase 3	Completed	2,734	2023-09
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight NCT05394519 · Novo Nordisk A/S	Phase 3	Completed	1,200	2023-02
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor NCT06221969 · Novo Nordisk A/S	Phase 3	Completed	1,024	2024-01
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both NCT06534411 · Novo Nordisk A/S	Phase 3	Completed	1,023	2024-11
A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight NCT06131437 · Novo Nordisk A/S	Phase 3	Completed	809	2023-11
A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight NCT05813925 · Novo Nordisk A/S	Phase 3	Completed	331	2023-04
A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight NCT05996848 · Novo Nordisk A/S	Phase 3	Completed	300	2023-08
A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight NCT06388187 · Novo Nordisk A/S	Phase 3	Completed	300	2024-06

Showing 25 of 40 matching registered studies (ongoing first). See all on ClinicalTrials.gov.

Latest randomized trials & key papers

From PubMed. The full story – mechanism, all results, risks – is in the CagriSema profile of the book.

2026Efficacy 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 et al. · The lancet. Diabetes & endocrinology · PMID 42009015
2026Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study
Buse JB et al. · The lancet. Diabetes & endocrinology · PMID 42251859
2026Efficacy 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 et al. · The lancet. Diabetes & endocrinology · PMID 42251860
2026CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1
Verma S et al. · Hypertension (Dallas, Tex. : 1979) · PMID 41328546
2026Cagrilintide-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 et al. · Lancet (London, England) · PMID 42251856
2026Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide
Nielsen MJF et al. · Clinical pharmacokinetics · PMID 42228334
2026Efficacy and safety of zalfermin co-administered with semaglutide in participants with fibrosis and cirrhosis due to metabolic dysfunction-associated steatohepatitis: a phase 2, dose-ranging, double-blind, randomised controlled trial
Loomba R et al. · The lancet. Gastroenterology & hepatology · PMID 42456707
2026Efficacy of CagriSema for Reaching Anthropometric Treatment Targets and Cardiometabolic Outcomes: A Secondary, Post hoc Analysis of REDEFINE 1
Busetto L et al. · Diabetes, obesity & metabolism · PMID 42503495

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