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

Completed · Phase 3

Conditions studied: Type 2 Diabetes

In brief

This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.

Key facts

Study ID

NCT06221969

Run by

Novo Nordisk A/S

People needed

1024

Starts

2024-01-16

Expected to finish

2026-04-06

Last updated by the study team

2026-04-22

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 ≥ 180 days before screening.
• Stable daily dose(s) ≥ 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 an sodium-glucose co-transporter-2 (SGLT2) inhibitor.
• HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
• Body mass index (BMI) of ≥ 30.0 kilogram per square meter (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…

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
• Renal impairment with estimated Glomerular Filtration Rate < 30 milliliter per minute per 1.73 square meter (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. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Where it is running

• Univ of Alabama_Birmingham — Birmingham, Alabama, United States
• Prime Medical Group, LLC — Gilbert, Arizona, 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
• Unity Health-Searcy Medical Center — Searcy, Arkansas, United States
• Velocity Clin Res-Chula Vista — Chula Vista, California, United States
• Headlands Research California, LLC — Escondido, California, United States
• Neighborhood Healthcare — Escondido, California, United States
• St. Jude Heritage Yorba Linda - Pediatric Ste D — Fullerton, California, United States
• Diabetes & Endocrine Specialists - La Mesa — La Mesa, California, United States
• Diabetes and Endocrine Specialists - La Mesa — La Mesa, California, United States
• Velocity Clin Res San Diego — La Mesa, California, United States
• Clinical Trials Research — Lincoln, California, United States
• Loma Linda Univ Hlth Cr Endo — Loma Linda, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• Desert Oasis Healthcare — Palm Springs, California, United States
• Velocity Clin Res - Panorama — Panorama City, California, United States
• Western University of Health Sciences — Pomona, California, United States
• Endocrinology Josel Cabaccan — San Jose, California, United States
• Mills-Peninsula Medical Center — San Mateo, California, United States
• NorCal Endocrinology and Internal Medicine — San Ramon, California, United States
• Premier Medical Center, Inc. — Toluca Lake, California, United States
• Velocity Clin Res - Panorama — Van Nuys, California, United States
• Synexus Clin Res-Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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