What this trial means for you
This study is opening soon at 21 US sites. It's studying CagriSema, Placebo CagriSema for diabetes mellitus, type 2.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
This study is being done to look at how well a study medicine called CagriSema helps people with diabetes lower their blood sugar. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. The study will last for about 38 weeks.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
Inclusion Criteria * Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening. * Glycated haemoglobin (HbA1c) 7.0-10.5 percent (%) (53-91 \[millimoles per mole\] mmol/mol) (both inclusive) as determined by the central laboratory at screening. * Stable daily dose \>= 90 days before screening of metformin at effective or maximum tolerated dose as judged by the investigator. * Body mass index (BMI) between 25.0 and 39.9 kilograms per square metre (kg/m\^2) (both inclusive) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening. Exclusion Criteria: * Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 30 millilitre per minute per 1.73 square metre (mL/min/1.73 m\^2) as determined by the central laboratory at screening. * Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. * 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. * Previous exposure to CagriSema in a clinical study.
Study sites by state
Arkansas
- Arkansas Clinical Research — Little Rock
California
- Paradigm Clinical Research — San Diego
- Encompass Clinical Research_Spring Valley — Spring Valley
- Diablo Clinical Research, Inc. — Walnut Creek
Florida
- Future Medical Research — Longwood
- New Horizon Research Center — Miami
- Clinical Site Partners Kendall Flourish Research — Miami
- West Orange Endocrinology — Ocoee
- Center for Diab,Obes & Metab — Pembroke Pines
- American Research Centers of Florida — Pembroke Pines
Georgia
- Hope Clin Res & Wellness — Conyers
Illinois
- Elevate Clinical Research — Gurnee
- Accellacare of Duly Oak Lawn — Oak Lawn
North Carolina
- KDCILM, LLC & Accellacare US, Inc. — Wilmington
Ohio
- Advanced Medical Research - Maumee — Maumee
Rhode Island
- Clinical Res Collaborative — Cumberland
Tennessee
- Clinical Research Associates — Nashville
Texas
- The Endocrine Center — Houston
- Radiance Clinical Research — Lampasas
- Quality Research Inc — San Antonio
- Medrasa Clinical Research — Sherman
View the official record on ClinicalTrials.gov →
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