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Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes | Clinical Trials | Clareo Health

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Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes

Effect of CagriSema, Semaglutide and Cagrilintide on Insulin Sensitivity and Pancreatic Endocrine Function in Adults With Type 2 Diabetes

NCT06403761•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This study will look at how CagriSema, semaglutide and cagrilintide regulate insulin effects in the body of people with type 2 diabetes (T2D). CagriSema is a new investigational medicine that combines two medicines called cagrilintide and semaglutide. Doctors may not yet prescribe CagriSema. Participants will either get CagriSema, semaglutide, cagrilintide, or a ''dummy'' medicine. Which treatment the participants will get is decided by chance. Participants will get the study medicine together with the current daily diabetes medicine metformin. Participants should not take other medicines for diabetes during the study. The study will last for about 42 weeks.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female.
•Aged 18-75 years (both inclusive) at the time of signing informed consent.
•Diagnosed with type 2 diabetes greater than or equal to (\>=) 180 days before screening.
•Stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for 90 or more days before screening with or without one additional oral antidiabetic drug (OAD), except for the use of glucagon-like peptide-1 (GLP-1) receptor agonists, or sodium-glucose co-transporter-2 (SGLT-2) inhibitors in case of a high risk of cardiovascular disease (as judged by the investigator), or established cardiovascular disease, or chronic kidney disease (Glomerular Filtration Rate (eGFR) less than (\<) 60 milliliter per minute per 1.73 square meter \[ml/min/1.73 m\^2\]).
•Glycated hemoglobin (HbA1c) at screening of 6.5-9.5 percent (48-80 millimoles per mole \[mmol/mol\]) (both inclusive) if on metformin only, or 6.0- 9.0 percent (42-75 mmol/mol) (both inclusive) if on metformin in combination with one other OAD. A minimum of 65% of randomised participants must have HbA1c \>= 7.0 % at screening.
•Body Mass index (BMI) between 25.0 and 45.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening.

Exclusion Criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
•Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 45 ml/min/1.73 m\^2 at screening.

Locations (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Key Dates

Start Date

May 6, 2024

Primary Completion Date

December 28, 2025

Completion Date

February 2, 2026

Last Updated

February 27, 2026

Enrollment

158

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

Semaglutide

DRUG

Cagrilintide

DRUG

Placebo semaglutide

DRUG

Placebo cagrilintide

DRUG

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Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

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RECRUITINGNA

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

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Diabetes Mellitus, Type 2Depressive Symptoms+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

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