← Back to Clinical Research · Sponsor: Novo Nordisk · Phase: 3 · ClinicalTrials.gov: NCT06221969
Currently Recruiting · Clinical Research
REIMAGINE-4 — CagriSema vs. Tirzepatide
A head-to-head comparison of CagriSema and Tirzepatide (Mounjaro) for blood-sugar and body-weight reduction in adults with Type 2 Diabetes on metformin, with or without an SGLT2 inhibitor.
About This Study
What is being studied?
This study evaluates how much CagriSema lowers blood sugar and body weight compared to Tirzepatide (Mounjaro) in adults with Type 2 Diabetes who are already being treated with metformin, with or without an SGLT2 inhibitor.
CagriSema is an investigational combination of two hormones — cagrilintide, a dual receptor agonist at the amylin and calcitonin receptors, and semaglutide (the same active ingredient in Ozempic and Wegovy), a GLP-1 receptor agonist. The combination has shown high efficacy for blood-sugar control and body-weight reduction in earlier-phase studies.
This is the first head-to-head comparison of Novo Nordisk’s CagriSema with Lilly’s Mounjaro — a particularly meaningful trial for the field of obesity and diabetes pharmacotherapy.
How does this fit with current medications?
| Medication | Receptor activity |
|---|---|
| Semaglutide (Ozempic / Wegovy) | Single agonist — GLP-1 |
| Tirzepatide (Mounjaro / Zepbound) | Dual agonist — GIP + GLP-1 |
| CagriSema (investigational) | Triple-receptor agonist — amylin + calcitonin + GLP-1 |
Eligibility Criteria
Who can participate?
Eligibility is determined at a screening visit. The summary below shows the key criteria — a complete review of inclusion and exclusion is performed in person before any study procedures begin.
Key Inclusion Criteria
- Age 18 years or older at the time of consent
- Diagnosed with Type 2 Diabetes for at least 180 days before screening
- On a stable daily dose for ≥ 90 days of metformin alone, or metformin plus an SGLT2 inhibitor (at an effective or maximum tolerated dose)
- HbA1c between 7.0% and 10.5% at screening
- BMI ≥ 30 kg/m² at screening
Key Exclusion Criteria
- Pregnant, planning pregnancy, or breastfeeding
- Renal impairment with eGFR < 30 mL/min/1.73m²
- Treatment with diabetes or obesity medications other than those listed above within 90 days of screening (short-term insulin up to 14 days, or prior insulin for gestational diabetes, are allowed)
- Uncontrolled or potentially unstable diabetic retinopathy or maculopathy
What Participation Involves
What can I expect?
If you are interested and appear to qualify based on a brief phone or in-office discussion, the next step is a screening visit. We review your full medical history, examine you, draw the laboratory tests required by the protocol, and — if you remain eligible — walk through the informed-consent document in detail before you decide whether to enroll.
Once enrolled, study visits are scheduled per protocol. Our team handles all study-related testing, drug dispensing, and reporting, and we coordinate with your primary endocrinologist or PCP throughout.
Generous visit stipends are provided. Study-related care and investigational product are at no cost to you. Participation is voluntary and you can withdraw at any time without affecting your ongoing clinical care.
Interested?
Talk to our research team
If REIMAGINE-4 sounds like it might be a fit for you — or if you have questions before deciding — please reach out. A short conversation is the easiest way to determine whether a screening visit makes sense.
Phone: 619-463-1293
Email: info@endotrials.org