CagriSema

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 13 of 82 publications on PubMed
Registered clinical trials 35 13 active
Adverse event reports 2 1 classified as serious
  • CagriSema is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 82 publications mentioning it, including 13 randomized controlled trials and 3 animal-only studies.
  • ClinicalTrials.gov lists 35 registered studies testing it (13 active).
  • FDA's adverse event system (FAERS) holds 2 reports mentioning it; 1 classified as serious. Reports do not prove causation.

Research topics

  • Obesity 37
  • Semaglutide 35
  • Weight Loss 27
  • Glucagon-Like Peptides 24
  • Diabetes Mellitus, Type 2 23
  • Islet Amyloid Polypeptide 22
  • Glucagon-Like Peptide-1 Receptor Agonists 21
  • Hypoglycemic Agents 21
  • Anti-Obesity Agents 18
  • Glucagon-Like Peptide 1 14

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Components

This is a vendor blend. Data for the blend itself only counts records that mention every component together; each component has its own page.

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 82
  • Human (MeSH) 52
  • Animal only 3
  • Clinical trials 13
  • Randomized controlled trials 13
  • Systematic reviews & meta-analyses 10
  • Case reports 0
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
35
Active
13
With posted results
1

Conditions studied

  • Obesity 19
  • Diabetes Mellitus, Type 2 7
  • Overweight 6
  • Type 2 Diabetes 5
  • Type 2 Diabetes Mellitus 2
  • Obesity or Overweight 2
  • Cardiovascular Disease 1
  • Diabetic Peripheral Neuropathy 1
  • Alcohol-related Liver Disease 1
  • Chronic Kidney Disease 1
  • Obesity & Overweight 1
Study Status Phase Start
Research Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema
NCT07817251 Novo Nordisk A/S
Recruiting Phase 3 September 16, 2026
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
Recruiting Phase 3 August 4, 2026
A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight
NCT07745504 Novo Nordisk A/S
Recruiting Phase 3 August 4, 2026
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
Recruiting Phase 3 May 21, 2026
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
Recruiting Phase 1 May 18, 2026
Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health)
NCT07527195 Novo Nordisk A/S
Recruiting Phase 1 April 10, 2026
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
NCT07253285 Novo Nordisk A/S
Recruiting Phase 3 January 8, 2026
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
Active, not recruiting Phase 1 September 26, 2025
The Role of the Amylin Analogue Cagrilintide in Bone Metabolism
NCT07010432 Novo Nordisk A/S
Recruiting Phase 1 June 12, 2025
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
Active, not recruiting Phase 3 June 3, 2025
Show 25 more studies
Study Status Phase Start
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
NCT06780449 Novo Nordisk A/S
Active, not recruiting Phase 3 February 10, 2025
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
Active, not recruiting Phase 3 March 1, 2023
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
NCT05567796 Novo Nordisk A/S
Active, not recruiting Phase 3 November 1, 2022
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
NCT07357740 Novo Nordisk A/S
Withdrawn Phase 2 August 27, 2026
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
NCT07357766 Novo Nordisk A/S
Withdrawn Phase 3 June 22, 2026
A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy
NCT06797869 Novo Nordisk A/S
Completed Phase 2 January 29, 2025
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
NCT06716307 Novo Nordisk A/S
Completed Phase 1 December 2, 2024
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
Completed Phase 3 November 5, 2024
A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight
NCT06388187 Novo Nordisk A/S
Completed Phase 3 June 24, 2024
Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease
NCT06409130 Novo Nordisk A/S
Completed Phase 2 May 20, 2024
Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes
NCT06403761 Novo Nordisk A/S
Completed Phase 1 May 6, 2024
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
NCT06131372 Novo Nordisk A/S
Completed Phase 2 April 1, 2024
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
NCT06323161 Novo Nordisk A/S
Completed Phase 3 March 26, 2024
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
NCT06323174 Novo Nordisk A/S
Completed Phase 3 March 19, 2024
A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight
NCT06289504 Novo Nordisk A/S
Completed Phase 1 February 27, 2024
A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight
NCT06207877 Novo Nordisk A/S
Completed Phase 1 February 23, 2024
A Study of How CagriSema Works on Appetite in People With Excess Body Weight
NCT06267092 Novo Nordisk A/S
Completed Phase 1 February 15, 2024
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
Completed Phase 3 January 16, 2024
A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
NCT06131437 Novo Nordisk A/S
Completed Phase 3 November 27, 2023
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
Completed Phase 3 September 27, 2023
A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight
NCT05996848 Novo Nordisk A/S
Completed Phase 3 August 15, 2023
A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight
NCT05813925 Novo Nordisk A/S
Completed Phase 3 April 3, 2023
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
Completed Phase 3 February 1, 2023
Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes
NCT04982575 Novo Nordisk A/S Results posted
Completed Phase 2 August 2, 2021
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity
NCT04940078 Novo Nordisk A/S
Completed Phase 1 July 7, 2021

All 35 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
2
Serious
1
With death outcome
0

Most reported reactions

  • Anal incontinence 1
  • Dyspnoea 1
  • Gastroenteritis 1
  • Loss of consciousness 1
  • Product information content complaint 1
  • Throat tightness 1
  • Thyroid mass 1
  • Vomiting 1

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.