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

RECRUITING

I'm interested ...!!

This study will look at how much CagriSema helps participants 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 "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.

Conditions:

Type 2 Diabetes

Study Start (Actual) 2024-03-19

Primary Completion (Estimated) 2025-10-07

Study Completion (Estimated) 2025-12-30

Enrollment (Estimated) 180

Study Type INTERVENTIONAL

Phase PHASE3

Locations:

📍 Huntington Park, California, United States

📍 Northridge, California, United States

📍 Santa Ana, California, United States

📍 Hollywood, Florida, United States

📍 Newton, Kansas, United States

📍 Boston, Massachusetts, United States

📍 Troy, Michigan, United States

📍 Kingsport, Tennessee, United States

📍 Dallas, Texas, United States

📍 San Antonio, Texas, United States

📍 Shavano Park, Texas, United States

📍 Newport News, Virginia, United States

📍 Beijing, Beijing, China

📍 Nanjing, Jiangsu, China

📍 Zhenjiang, Jiangsu, China

📍 Ji'Nan, Shandong, China

📍 Debrecen, Hajdu-Bihar Varmegye, Hungary

📍 Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary

📍 Bergamo, Italy

📍 Catanzaro, Italy

📍 Milano, Italy

📍 Roma, Italy

📍 Rzeszow, Podkarpackie, Poland

📍 Białystok, Poland

📍 Lodz, Poland

📍 Warszawa, Poland

📍 Al Ahsa, Saudi Arabia

📍 Jeddah, Saudi Arabia

📍 Riyadh, Saudi Arabia

📍 Belgrade, Serbia

📍 Zajecar, Serbia

More locations available...

Eligibility Criteria

Description

Inclusion Criteria:

* Male or female
* Age 18 years or above at the time of signing the informed consent
* Diagnosed with type 2 diabetes \>=30 days before screening
* HbA1c 7.0-9.5 percent (53-80 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening
* Body mass index (BMI) \>=23 kilograms 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

Exclusion Criteria:

* 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 less than 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 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
* History of use of any injectable therapy for diabetes or obesity. 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 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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2024-03-15
First Submitted that Met QC Criteria2024-03-15
First Posted2024-03-21

Study Record Updates

Last Update Submitted that Met QC Criteria2024-07-16
Last Update Posted2024-07-17
Last Verified2024-07