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

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

Key facts

Study ID

NCT06065540

Run by

Novo Nordisk A/S

People needed

2734

Starts

2023-09-27

Expected to finish

2026-01-06

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female (sex at birth).
• Age 18 years or above at the time of signing the informed consent.
• Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening.
• Stable daily dose(s) greater than or equal to 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors.
• Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening.
• Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

You may not qualify if…

• Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square metre (mL/min/1.73 m\^2) as determined by central laboratory at screening.
• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation.

Where it is running

• Hospital Topolšica — Topolšica, Slovenia
• Synexus Clin Res-Birmingham — Birmingham, Alabama, United States
• Univ of Alabama_Birmingham — Birmingham, Alabama, United States
• Cahaba Research — Pelham, Alabama, United States
• Velocity Clinical Research-Phoenix — Phoenix, Arizona, United States
• Synexus Rsch /Cnt Phnx Med C — Phoenix, Arizona, United States
• Arkansas Clinical Research — Little Rock, Arkansas, United States
• Velocity Clinical Res-Banning — Banning, California, United States
• Velocity Clin Res-Chula Vista — Chula Vista, California, United States
• John Muir Physicians Network — Concord, California, United States
• Headlands Research California, LLC — Escondido, California, United States
• Velocity Clin Res Gardena — Gardena, California, United States
• Velocity Clin Res San Diego — La Mesa, California, United States
• Loma Linda Univ Hlth Cr Endo — Loma Linda, California, United States
• Facey Medical Foundation — Mission Hills, California, United States
• Desert Oasis Hlthcr Med Group — Palm Springs, California, United States
• Velocity Clin Res- San Bern — San Bernardino, California, United States
• Linda Vista Health Care Ctr — San Diego, California, United States
• Velocity Clin Res Santa Ana — Santa Ana, California, United States
• Premier Medical Center, Inc. — Toluca Lake, California, United States
• Velocity Clin Res - Panorama — Van Nuys, California, United States
• Optumcare Clinical Trials,LLC-Golden — Colorado Springs, Colorado, United States
• Northeast Research Institute — Jacksonville, Florida, United States
• Clinical Trial Services Corp — Miami, Florida, United States
• K R Hospital — Mysuru, Karnataka, India

Full record on ClinicalTrials.gov

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