Research information only, not medical advice. Cagrilintide (AM833) is an investigational long-acting amylin analogue developed by Novo Nordisk for weight management. It is not approved by the FDA as a standalone drug. Its lead program is the fixed-dose combination with semaglutide, CagriSema — described as the first injectable GLP-1 receptor agonist and amylin analogue combination — for which Novo Nordisk submitted a New Drug Application to the FDA on December 18, 2025; the FDA is expected to review the application in 2026.
Cagrilintide at a glance
The strongest evidence comes from the phase 3 REDEFINE program evaluating the cagrilintide–semaglutide fixed-dose combination (CagriSema) in adults with obesity. In REDEFINE 1, CagriSema produced a mean body-weight reduction of 20.4% at 68 weeks on the treatment-policy estimand (22.7% among participants who stayed on treatment), versus about 3% with placebo. As a standalone agent, cagrilintide has been evaluated in earlier randomised trials for obesity but remains investigational; much of the strongest weight-loss data reflects the combination with semaglutide rather than cagrilintide alone.
See how we grade evidence for the methodology behind this page.
Evidence profile
79 studies- Human RCT 10 · 13%
- Human trial 3 · 4%
- Review 34 · 43%
- Animal 18 · 23%
- In-vitro 7 · 9%
- Unknown 7 · 9%
The longer the green, the stronger the human evidence. For most research peptides the bar is dominated by animal and in-vitro work, which is a signal to read every claim carefully.
Regulatory status
- 2025-12-18 US-FDA
Novo Nordisk submitted a New Drug Application to the FDA for CagriSema (cagrilintide plus semaglutide) for weight management, based on the phase 3 REDEFINE program. source
Clinical trials
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A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity
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Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes
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A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
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A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Works in Participants With Reduced Liver Function and in Healthy Participants With Normal Liver Function and How Cagrilintide is Absorbed and Used by the Body
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A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
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REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
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A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy Participants
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A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight
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A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight
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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
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A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo
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A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
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A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight
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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
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A Study of How CagriSema Works on Appetite in People With Excess Body Weight
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A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight
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A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin
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A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise
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A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight
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Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes
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Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease
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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
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A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity
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A Study on How NNC0174-1213 Works in People With Overweight or Obesity.
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A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
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A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy
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The Role of the Amylin Analogue Cagrilintide in Bone Metabolism
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A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
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A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet
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Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide
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Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide
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A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
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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
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A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
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A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
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A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or Obese
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Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health)
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A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
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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
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A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity
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A Research Study to Compare Blood Levels of Two Different Versions of Cagrilintide in Adults With Excess Body Weight
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Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events
Indexed research
Sorted by evidence level, strongest first.
- Human RCT 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
- Human RCT 2026Comparative Effectiveness of CagriSegma, Semaglutide, Cagrilintide and Tirzepatide in the Management of Overweight and Obesity: A Network Meta-Analysis of Randomized Clinical Trials
This network meta-analysis of 25 RCTs found that tirzepatide 15 mg and CagriSema achieved the greatest weight reduction, including ≥20% body weight loss, with gastrointestinal adverse events increasing with treatment intensity and serious adverse events comparable to placebo.
- Human RCT 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
This phase 3a trial found that once-weekly cagrilintide-semaglutide significantly reduced HbA1c and body weight compared to placebo in adults with type 2 diabetes inadequately controlled by diet and exercise.
- Human RCT 2026Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study
This phase 3 trial found that cagrilintide-semaglutide (2.4 mg each) was superior to semaglutide 2.4 mg in reducing HbA1c in people with type 2 diabetes and overweight or obesity.
- Human RCT 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
- Human RCT 2026CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1
- Human RCT 20261035-OR: Effects of CagriSema on Appetite and Functional Brain Activity in People with Overweight/Obesity
This randomized controlled trial in 113 adults with overweight/obesity found that 22 weeks of CagriSema treatment significantly improved appetite control and altered brain responses to food cues compared to placebo.
- Human RCT 20261695-P: Effect of CagriSema on Eating Control and Behavior: REDEFINE 1
This randomized controlled trial (REDEFINE 1) assessed the effects of CagriSema on eating control and behavior in adults with overweight or obesity, finding significant improvements compared to placebo and some individual components.
- Human RCT 2021Safety and Tolerability of Concomitant Administration of Multiple-Dose AM833 With Semaglutide 2.4 MG for Weight Management
This phase 1 randomized controlled trial found that concomitant administration of AM833 with semaglutide 2.4 mg was generally well tolerated and led to greater weight loss than placebo plus semaglutide.
- Human RCT 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
This phase 2 randomized controlled trial evaluated zalfermin co-administered with semaglutide in patients with MASH and fibrosis or cirrhosis, finding no significant improvement in liver fibrosis with the combination compared to placebo at 52 weeks.
+ 69 more studies indexed for Cagrilintide.
Frequently asked questions
- Is Cagrilintide approved for human use?
- Cagrilintide (AM833) is an investigational long-acting amylin analogue developed by Novo Nordisk for weight management. It is not approved by the FDA as a standalone drug. Its lead program is the fixed-dose combination with semaglutide, CagriSema — described as the first injectable GLP-1 receptor agonist and amylin analogue combination — for which Novo Nordisk submitted a New Drug Application to the FDA on December 18, 2025; the FDA is expected to review the application in 2026.
- What does the research on Cagrilintide show?
- The strongest evidence comes from the phase 3 REDEFINE program evaluating the cagrilintide–semaglutide fixed-dose combination (CagriSema) in adults with obesity. In REDEFINE 1, CagriSema produced a mean body-weight reduction of 20.4% at 68 weeks on the treatment-policy estimand (22.7% among participants who stayed on treatment), versus about 3% with placebo. As a standalone agent, cagrilintide has been evaluated in earlier randomised trials for obesity but remains investigational; much of the strongest weight-loss data reflects the combination with semaglutide rather than cagrilintide alone.