A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepa… (NCT06534411) | Clinical Trial Compass
Active — Not RecruitingPhase 3
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, SGLT2 Inhibitor or Both
United States, Argentina, Australia1,023 participantsStarted 2024-11-05
Plain-language summary
This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female (sex at birth).
* Age 18 years or above at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 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
* sodium-glucose co-transporter 2 inhibitor (SGLT2i)
* Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
* Body mass index (BMI) \>= 30 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.
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 anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is allowed.
* Uncontrolled and potentially unstable diabeti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing CagriSema directly against tirzepatide for blood sugar and weight loss in people already on metformin or an SGLT2 inhibitor — given where my own HbA1c and weight stand right now, does my doctor think this kind of head-to-head comparison trial could be relevant to the choices I'm already facing?
2Since this is a Phase 3 trial, there should be more safety and dosing data available than in earlier phases — can my doctor walk me through what is currently known about CagriSema's side effect profile, especially compared to tirzepatide which already has a lot of real-world use?
3The trial is no longer recruiting, so I can't join it — but can my doctor tell me whether CagriSema or a similar combination drug might eventually become an option for me, and whether waiting for those results could affect my treatment plan today?
4My current treatment already includes metformin or an SGLT2 inhibitor, which matches this trial's population — does my doctor think I should stick with or adjust my existing regimen now, or would it make sense to see what this trial's results show about adding a GLP-1/amylin combination on top of those medications?
5This trial is measuring both HbA1c reduction and body weight change as its main goals — given my personal health priorities, does my doctor think targeting both of those outcomes at once is the right approach for me, or are there other options worth considering first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Glycated Haemoglobin (HbA1c)
Timeframe: From baseline (week 0) to end of treatment (week 60)
2
Relative Change in Body Weight
Timeframe: From baseline (week 0) to end of treatment (week 60)