A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
Completed · Phase 3 · Has a placebo group
Conditions studied: Overweight, Obesity, Type 2 Diabetes Mellitus
In brief
This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
Key facts
- Study ID
- NCT05394519
- Run by
- Novo Nordisk A/S
- People needed
- 1200
- Starts
- 2023-02-01
- Expected to finish
- 2025-02-03
- Last updated by the study team
- 2026-01-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female
- Age above or equal to 18 years at the time of signing informed consent
- BMI greather than or equal to 27.0 kg/m\^2
- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
- Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label
- Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
- HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening
You may not qualify if…
- Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
- Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2, as measured by the central laboratory at screening
- 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
- Ramathibodi Hospital — Bangkok, Thailand
- Selma Medical Associates — Winchester, Virginia, United States
- John Muir Physicians Network — Concord, California, United States
- Headlands Research California, LLC — Escondido, California, United States
- Providence Medical Foundation — Fullerton, California, United States
- St. Jos Heritage Hlthcr_Fllrtn — Fullerton, California, United States
- Diabetes/Lipid Mgmt & Res Ctr — Huntington Beach, California, United States
- Clinical Trials Research — Lincoln, California, United States
- Velocity Clin Res Los Angeles — Los Angeles, California, United States
- Velocity Clin Res Wstlke — Los Angeles, California, United States
- Desert Oasis Hlthcr Med Group — Palm Springs, California, United States
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States
- New West Physicians,Inc. — Golden, Colorado, United States
- Clinical Res Of W Florida Inc — Clearwater, Florida, United States
- Northeast Research Institute — Fleming Island, Florida, United States
- Jacksonville Ctr For Clin Res — Jacksonville, Florida, United States
- Renstar Medical Research — Ocala, Florida, United States
- AdventHealth Diab Inst — Orlando, Florida, United States
- Florida Institute for Clinical Research, LLC — Orlando, Florida, United States
- Oviedo Medical Research, LLC — Oviedo, Florida, United States
- Endo Res Solutions Inc — Roswell, Georgia, United States
- East West Med Res Inst — Honolulu, Hawaii, United States
- Cedar-Crosse Research Center — Chicago, Illinois, United States
- Iowa Diab & Endo Res Center — West Des Moines, Iowa, United States
- Rajavithi Hospital — Bangkok, Thailand
Full record on ClinicalTrials.gov
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