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
Completed · Phase 3 · Has a placebo group
Conditions studied: Type 2 Diabetes
In brief
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.
Key facts
- Study ID
- NCT06323174
- Run by
- Novo Nordisk A/S
- People needed
- 189
- Starts
- 2024-03-19
- Expected to finish
- 2025-12-22
- Last updated by the study team
- 2026-04-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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 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
Where it is running
- Nat Res Inst Huntington Park — Huntington Park, California, United States
- Valley Clinical Trials, Inc. — Northridge, California, United States
- Southern California Dermatology — Santa Ana, California, United States
- Encore Medical Research LLC — Hollywood, Florida, United States
- Headlands Research Orlando — Orlando, Florida, United States
- Encore Medical Research of Weston — Weston, Florida, United States
- Alliance for Multispec Res — Newton, Kansas, United States
- Brigham & Women's Hospital — Boston, Massachusetts, United States
- Arcturus HC PLC Troy Med Res — Troy, Michigan, United States
- Southgate Medical Group, LLP — West Seneca, New York, United States
- Summit Research Network Oregon Inc. — Portland, Oregon, United States
- Holston Medical Group — Kingsport, Tennessee, United States
- Amarillo Medical Specialists — Amarillo, Texas, United States
- Elligo Clin Res Centre — Austin, Texas, United States
- Headlands Research Brownsville — Brownsville, Texas, United States
- Velocity Clinical Res-Dallas — Dallas, Texas, United States
- Northeast Clinical Research of San Antonio — San Antonio, Texas, United States
- Consano Clinical Research, LLC — Shavano Park, Texas, United States
- Sugar Lakes Family Practice PA — Sugar Land, Texas, United States
- Valley Diab. & Endo Comp Ctr — Weslaco, Texas, United States
- TPMG Clinical Research — Newport News, Virginia, United States
- Chinese People's Liberation Army General Hospital-Endocrinology — Beijing, Beijing Municipality, China
- The Second Affiliated Hospital of Nanjing Medical University-Endocrinology — Nanjing, Jiangsu, China
- The Affiliated Hospital of Jiangsu University-Endocrinology — Zhenjiang, Jiangsu, China
- Jinan Central Hospital — Ji'Nan, Shandong, China
Full record on ClinicalTrials.gov
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