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REDEFINE 3: A research study to see the effects of CagriSema in people living with diseases in the heart and blood vessels
EU CTIS ID: 2023-506924-94-00
What this study is testing
To confirm non-inferiority of CagriSema 2.4mg/2.4mg versus placebo with respect to time to first major adverse cardiovascular event (MACE)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female
- Age above or equal to 55 years at the time of signing informed consent
- Body mass index (BMI) ≥ 25.0 kg/m2
- Established CVD as evidenced by at least one of the following: • Prior myocardial infarction • Prior stroke (ischemic or haemorrhagic stroke) • Symptomatic peripheral arterial disease (PAD) defined as at least one of the following: a. Intermittent claudication with an ankle-brachial index (ABI) < 0.85 at rest b. Intermittent claudication with a ≥ 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound c. Prior revascularization procedure of a lower extremity peripheral artery d. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)
- For participants with T2D at screening, the following inclusion criteria also apply: Diagnosed with type 2 diabetes mellitus (T2D) ≥ 180 days before screening. HbA1c 6.5%-10% (48-86 mmol/mol) (both inclusive), as measured by central laboratory at screening. Treatment with either: a. Lifestyle intervention alone b. 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), DPP4-inhibitors, thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local label c. Basal insulin alone or in combination with up to two marketed OADs (refer to b. above), all according to local label
You likely can't join if
- Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 60 days before screening
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- Heart failure classified as being in New York Heart Association (NYHA) Class IV at screening
- Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90 days before screening
- End stage renal disease defined as eGFR < 15 mL/min/1.73 m2, as measured by the central laboratory at screening
- Chronic or intermittent haemodialysis or peritoneal dialysis
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Mexico
- United States
- Serbia
- Australia
- India
- Canada
- Colombia
- Malaysia
- Brazil
- Thailand
- United Kingdom
- Turkey
- Argentina
- South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Mexico; United States; Serbia; Australia; India and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.