# Cagrilintide

Cagrilintide has 39 registered human trials. It is marketed for 3 different uses.

**In short**

- 39 registered human trials exist for Cagrilintide.
- Cagrilintide is not FDA-approved for any use.
- What has actually been studied: obesity, alcohol-related liver disease, overweight.
- Last checked against ClinicalTrials.gov on 2026-07-30.

## What it is

Cagrilintide is a long-acting analogue of amylin, a hormone released by the pancreas alongside insulin. Novo Nordisk modified it for once-weekly dosing. It acts on amylin and calcitonin receptors to increase fullness and slow stomach emptying — a different mechanism from the GLP-1 drugs it is usually paired with.

## Where the claims come from

Unlike most compounds on this site, the interest here is pharmaceutical rather than grey-market: amylin agonism produces weight loss that adds to what GLP-1 drugs achieve alone, which is why it is being developed as a combination. Most of its registered trials study it together with semaglutide rather than by itself, under the name CagriSema.

## What evidence exists outside the registry

The evidence base is conventional drug development — published Phase 1 through Phase 3 data in peer-reviewed journals. The open question is not whether trials exist but whether the results support approval, which the FDA has not yet decided.

**Sources for the above**

- [NCT05567796 — REDEFINE 1](https://clinicaltrials.gov/study/NCT05567796) — Phase 3, 3,400 participants, cagrilintide with semaglutide in obesity.
- [NCT05394519 — REDEFINE 2](https://clinicaltrials.gov/study/NCT05394519) — Phase 3 in type 2 diabetes with obesity.

## Approved for

Not approved by the FDA for any use. Nothing has been reviewed for safety, effectiveness or manufacturing quality.

## Studied for

- Obesity
- Alcohol-related Liver Disease
- Overweight
- Obesity or Overweight
- Diabetes Mellitus, Type 2
- Obese
- Diabetic Peripheral Neuropathy
- Chronic Kidney Disease
- Type 2 Diabetes
- Hepatic Impairment
- Healthy Volunteers
- Type 2 Diabetes Mellitus
- Obesity & Overweight
- Cardiovascular Disease

## Marketed for

- Weight loss
- Appetite suppression
- Metabolic health

## What regulators have said

We searched FDA's list of bulk drug substances nominated for use in pharmacy compounding and did not find Cagrilintide on it, in any category. There is no published FDA safety assessment to report — that is not the same as having been reviewed and cleared.


## Every trial on record

| Trial ID | Title | Condition | Phase | Status | Enrolled |
|---|---|---|---|---|---|
| [NCT05804162](https://clinicaltrials.gov/study/NCT05804162) | A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy Participants | Obesity | Phase 1 | COMPLETED | 107 |
| [NCT06409130](https://clinicaltrials.gov/study/NCT06409130) | Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease | Alcohol-related Liver Disease | Phase 2 | COMPLETED | 270 |
| [NCT07605052](https://clinicaltrials.gov/study/NCT07605052) | A Research Study to Compare Blood Levels of Two Different Versions of Cagrilintide in Adults With Excess Body Weight | Overweight, Obesity | Phase 1 | ACTIVE_NOT_RECRUITING | 50 |
| [NCT05813925](https://clinicaltrials.gov/study/NCT05813925) | A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight | Obesity or Overweight | Phase 3 | COMPLETED | 331 |
| [NCT07184086](https://clinicaltrials.gov/study/NCT07184086) | A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet | Obesity | Phase 1 | RECRUITING | 80 |
| [NCT06534411](https://clinicaltrials.gov/study/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 With Metformin, SGLT2 Inhibitor or Both | Diabetes Mellitus, Type 2 | Phase 3 | COMPLETED | 1023 |
| [NCT07253285](https://clinicaltrials.gov/study/NCT07253285) | A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight | Overweight, Obesity | Phase 3 | RECRUITING | 460 |
| [NCT05996848](https://clinicaltrials.gov/study/NCT05996848) | A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight | Obesity or Overweight | Phase 3 | COMPLETED | 300 |
| [NCT07011667](https://clinicaltrials.gov/study/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 | Obesity | Phase 3 | ACTIVE_NOT_RECRUITING | 609 |
| [NCT07411560](https://clinicaltrials.gov/study/NCT07411560) | 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 | Overweight, Obese | Phase 1 | RECRUITING | 100 |
| [NCT06797869](https://clinicaltrials.gov/study/NCT06797869) | A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy | Diabetes Mellitus, Type 2, Diabetic Peripheral Neuropathy | Phase 2 | ACTIVE_NOT_RECRUITING | 142 |
| [NCT06131372](https://clinicaltrials.gov/study/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 Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo | Chronic Kidney Disease, Type 2 Diabetes | Phase 2 | COMPLETED | 626 |
| [NCT06719011](https://clinicaltrials.gov/study/NCT06719011) | A Study on How NNC0174-1213 Works in People With Overweight or Obesity. | Obesity, Overweight | Phase 1 | RECRUITING | 177 |
| [NCT05564104](https://clinicaltrials.gov/study/NCT05564104) | 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 | Hepatic Impairment, Healthy Volunteers | Phase 1 | COMPLETED | 32 |
| [NCT06131437](https://clinicaltrials.gov/study/NCT06131437) | A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight | Obesity | Phase 3 | COMPLETED | 809 |
| [NCT05567796](https://clinicaltrials.gov/study/NCT05567796) | A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight | Obesity | Phase 3 | ACTIVE_NOT_RECRUITING | 3400 |
| [NCT06716307](https://clinicaltrials.gov/study/NCT06716307) | 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 | Obesity | Phase 1 | COMPLETED | 18 |
| [NCT07607587](https://clinicaltrials.gov/study/NCT07607587) | Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events | Obesity, Overweight | Phase 1 | RECRUITING | 114 |
| [NCT06289504](https://clinicaltrials.gov/study/NCT06289504) | A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight | Obesity | Phase 1 | COMPLETED | 34 |
| [NCT06780449](https://clinicaltrials.gov/study/NCT06780449) | A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity | Obesity | Phase 3 | ACTIVE_NOT_RECRUITING | 400 |
| [NCT05394519](https://clinicaltrials.gov/study/NCT05394519) | A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight | Overweight, Obesity | Phase 3 | COMPLETED | 1200 |
| [NCT07597018](https://clinicaltrials.gov/study/NCT07597018) | A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity | Obesity, Overweight | Phase 1 | RECRUITING | 234 |
| [NCT04940078](https://clinicaltrials.gov/study/NCT04940078) | A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity | Obesity & Overweight | Phase 1 | COMPLETED | 40 |
| [NCT07010432](https://clinicaltrials.gov/study/NCT07010432) | The Role of the Amylin Analogue Cagrilintide in Bone Metabolism | Obesity | Phase 1 | RECRUITING | 144 |
| [NCT04982575](https://clinicaltrials.gov/study/NCT04982575) | Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes | Diabetes Mellitus, Type 2 | Phase 2 | COMPLETED | 92 |
| [NCT06267092](https://clinicaltrials.gov/study/NCT06267092) | A Study of How CagriSema Works on Appetite in People With Excess Body Weight | Overweight, Obesity | Phase 1 | COMPLETED | 164 |
| [NCT06388187](https://clinicaltrials.gov/study/NCT06388187) | A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight | Obesity | Phase 3 | COMPLETED | 300 |
| [NCT07220642](https://clinicaltrials.gov/study/NCT07220642) | Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide | Obesity, Overweight | Phase 3 | ACTIVE_NOT_RECRUITING | 300 |
| [NCT06207877](https://clinicaltrials.gov/study/NCT06207877) | A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight | Obesity | Phase 1 | COMPLETED | 62 |
| [NCT06221969](https://clinicaltrials.gov/study/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 With Metformin With or Without an SGLT2 Inhibitor | Type 2 Diabetes | Phase 3 | COMPLETED | 1024 |
| [NCT07282613](https://clinicaltrials.gov/study/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 Diabetes | Diabetes Mellitus, Type 2 | Phase 3 | NOT_YET_RECRUITING | 80 |
| [NCT06403761](https://clinicaltrials.gov/study/NCT06403761) | Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes | Diabetes Mellitus, Type 2 | Phase 1 | COMPLETED | 158 |
| [NCT06323174](https://clinicaltrials.gov/study/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 With Diet and Exercise | Type 2 Diabetes | Phase 3 | COMPLETED | 189 |
| [NCT07527195](https://clinicaltrials.gov/study/NCT07527195) | Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health) | Obesity | Phase 1 | RECRUITING | 100 |
| [NCT06065540](https://clinicaltrials.gov/study/NCT06065540) | 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 | Type 2 Diabetes Mellitus | Phase 3 | COMPLETED | 2734 |
| [NCT06323161](https://clinicaltrials.gov/study/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 With Once-daily Basal Insulin With or Without Metformin | Type 2 Diabetes | Phase 3 | COMPLETED | 274 |
| [NCT07557953](https://clinicaltrials.gov/study/NCT07557953) | A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity | Overweight, Obesity | Phase 1 | RECRUITING | 120 |
| [NCT07220759](https://clinicaltrials.gov/study/NCT07220759) | Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide | Overweight, Obesity | Phase 3 | ACTIVE_NOT_RECRUITING | 330 |
| [NCT05669755](https://clinicaltrials.gov/study/NCT05669755) | REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels | Cardiovascular Disease | Phase 3 | ACTIVE_NOT_RECRUITING | 7101 |

## Common questions

**How many human trials does Cagrilintide have?**
39, each listed above with a link to its original record.

**Is Cagrilintide FDA approved?**
No. It is not approved by the FDA for any indication.

**Where does this data come from?**
ClinicalTrials.gov. We count interventional human studies only. Every trial
links to its original record.

---

*Automated aggregation from public registries. Not medical advice. No physician
has reviewed this page. Source: https://www.whatsactuallyknown.com/compounds/cagrilintide*