CagriSema (Cagrilintide B and Semaglutide I) History and Updates

132 events · 2021 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
132
Trial Milestones
0
Pivotal Publications
CagriSema (Cagrilintide B and Semaglutide I) — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2021202220232024202520262027202820292030Trial: NCT07817251 2026-09-16 → 2027-06-09 (primary completion)Trial: NCT07357740 2026-08-27 → 2027-08-25 (primary completion)Trial: NCT07745504 2026-08-04 → 2027-05-18 (primary completion)Trial: NCT07282613 2026-08-04 → 2029-09-07 (primary completion)Trial: NCT07357766 2026-06-22 → 2027-11-29 (primary completion)Trial: NCT07607587 2026-05-29 → 2027-11-19 (primary completion)Trial: NCT07564414 2026-05-21 → 2028-02-23 (primary completion)Trial: NCT07557953 2026-04-28 → 2027-04-13 (primary completion)Trial: NCT07527195 2026-04-10 → 2028-04-28 (primary completion)Trial: NCT07411560 2026-02-09 → 2027-01-26 (primary completion)Trial: NCT07253285 2026-01-08 → 2030-03-20 (primary completion)Trial: NCT07220642 2025-11-05 → 2027-05-11 (primary completion)Trial: NCT07220759 2025-11-05 → 2027-05-12 (primary completion)Trial: NCT07184086 2025-09-26 → 2027-10-12 (primary completion)Trial: NCT07010432 2025-06-12 → 2028-05-03 (primary completion)Trial: NCT07011667 2025-06-03 → 2027-03-01 (primary completion)Trial: NCT06780449 2025-02-10 → 2028-08-28 (primary completion)Trial: NCT06797869 2025-01-29 → 2026-08-21 (primary completion)Trial: NCT06719011 2024-12-03 → 2026-07-20 (primary completion)Trial: NCT06716307 2024-12-02 → 2025-03-28 (primary completion)Trial: NCT06534411 2024-11-05 → 2026-06-02 (primary completion)Trial: NCT06388187 2024-06-24 → 2026-04-22 (primary completion)Trial: NCT06409130 2024-05-20 → 2025-11-21 (primary completion)Trial: NCT06403761 2024-05-06 → 2025-12-28 (primary completion)Trial: NCT06131372 2024-04-01 → 2025-09-24 (primary completion)Trial: NCT06323161 2024-03-26 → 2025-09-09 (primary completion)Trial: NCT06323174 2024-03-19 → 2025-10-01 (primary completion)Trial: NCT06289504 2024-02-27 → 2024-10-16 (primary completion)Trial: NCT06207877 2024-02-23 → 2024-10-16 (primary completion)Trial: NCT06267092 2024-02-15 → 2025-04-07 (primary completion)Trial: NCT06221969 2024-01-16 → 2026-03-04 (primary completion)Trial: NCT06131437 2023-11-27 → 2025-12-08 (primary completion)Trial: NCT06065540 2023-09-27 → 2025-11-19 (primary completion)Trial: NCT05996848 2023-08-15 → 2025-01-06 (primary completion)Trial: NCT05804162 2023-04-12 → 2023-08-12 (primary completion)Trial: NCT05564104 2023-04-05 → 2024-09-06 (primary completion)Trial: NCT05813925 2023-04-03 → 2025-01-17 (primary completion)Trial: NCT05669755 2023-03-01 → 2027-09-01 (primary completion)Trial: NCT05394519 2023-02-01 → 2025-01-28 (primary completion)Trial: NCT05567796 2022-11-01 → 2024-10-30 (primary completion)Trial: NCT04982575 2021-08-02 → 2022-07-07 (primary completion)Trial: NCT04940078 2021-07-07 → 2022-01-19 (primary completion)Results posted — 2023-07-27 Trial results posted: NCT04982575 Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetestoday (2026-10-16)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-10-16Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for CagriSema (Cagrilintide B and Semaglutide I) since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (8)

2026
2025
2024

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07411560
A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07011667
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07557953
A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07220759
Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07745504
A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07357740
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05669755
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07184086
A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07607587
Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07357766
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07564414
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
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07527195
Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health)
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07282613
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Di
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07253285
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight

Past events

2026
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07817251
Research Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07605052
A Research Study to Compare Blood Levels of Two Different Versions of Cagrilintide in Adults With Excess Body Weight
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07357740
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06797869
A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07605052
A Research Study to Compare Blood Levels of Two Different Versions of Cagrilintide in Adults With Excess Body Weight
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07745504
A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07282613
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Di
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06797869
A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07357766
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06534411
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07607587
Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07564414
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
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07557953
A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06388187
A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07527195
Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health)
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06221969
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07411560
A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07253285
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
2025
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06403761
Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06409130
Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-relat
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06065540
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People Wi
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07220642
Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07220759
Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06323174
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated Wit
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07184086
A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06131372
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
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06323161
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated Wit
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07011667
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06716307
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06780449
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06797869
A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05394519
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
2024
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06716307
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06534411
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06207877
A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06289504
A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05564104
A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Works in Participants With Reduced Liver Function and in Healthy
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06388187
A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06409130
Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-relat
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06403761
Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06131372
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
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06323161
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated Wit
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06323174
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated Wit
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06289504
A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06207877
A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06221969
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated
2023
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06131437
A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06065540
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People Wi
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05996848
A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight
Results posted· ClinicalTrials.gov
Trial results posted: NCT04982575
Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05804162
A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy Participants
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05564104
A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Works in Participants With Reduced Liver Function and in Healthy
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05813925
A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05669755
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05394519
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
2022
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05567796
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04982575
Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT04940078
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight
2021
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04982575
Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT04940078
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.