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Amylin Analog
CagriSema for Cardiovascular Disease (REDEFINE 3 Trial)
Phase 3
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week -3) to end of study (up to 242 weeks or more)
Awards & highlights
REDEFINE 3 Trial Summary
This trial will study the effects of CagriSema in obese people with heart disease. Participants will get one injection a week & have 22 clinic visits over 3 years, with a chance of getting CagriSema or a placebo. Women must be on birth control.
Who is the study for?
This trial is for people aged 55 or older with a history of heart attack, stroke, or cardiovascular disease (CVD), and a BMI of at least 30. If they have type 2 diabetes (T2D), they must be diagnosed for over 180 days and meet specific CVD criteria. Excluded are those on dialysis, with recent severe cardiac events, end-stage renal disease, or who've used certain diabetes drugs recently.Check my eligibility
What is being tested?
The study tests the effects of CagriSema versus placebo on preventing heart attacks and strokes in individuals with cardiovascular issues. Participants will receive either the actual drug or placebo by injection once weekly at random. The trial aims to last up to four and a half years.See study design
What are the potential side effects?
While not specified here, common side effects for medications like Cagrilintide and Semaglutide may include nausea, diarrhea, weight loss, low blood sugar levels in diabetics; however individual experiences can vary.
REDEFINE 3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (week -3) to end of study (up to 242 weeks or more)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week -3) to end of study (up to 242 weeks or more)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to first occurrence of major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke
Secondary outcome measures
Change from baseline in Interleukin 1 beta (IL-1β)
Change from baseline in Interleukin 6 (IL-6)
Change from baseline in high-sensitivity C-reactive protein (hsCRP)
+22 moreREDEFINE 3 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CagriSema 2.4 mg/2.4 mgExperimental Treatment2 Interventions
Participants will receive 2.4 milligrams (mg) cagrilintide and 2.4 mg semaglutide subcutaneously (s.c.) once-weekly after a dose escalation period of 16 weeks during the maintenance period of 219 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide s.c. once weekly for 235 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cagrilintide
2023
Completed Phase 1
~150
Semaglutide
2019
Completed Phase 4
~5160
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,408,068 Total Patients Enrolled
Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S
36 Previous Clinical Trials
516,006 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stroke before.I have had a procedure to improve blood flow in my leg's artery.I have had a heart attack before.My kidney function is very low, with an eGFR below 15.I haven't taken GLP-1 drugs in the last 90 days.I am either male or female.My heart condition severely limits my physical activity.I am on long-term or occasional dialysis.I am taking basal insulin alone or with up to two other approved diabetes pills.I haven't had a heart attack, stroke, or severe heart chest pain in the last 60 days.I am managing my condition with lifestyle changes only.I am 55 years old or older.I am currently taking 1-3 prescribed oral diabetes medications.I am scheduled for a procedure to improve blood flow to my heart, neck, or limbs.I have leg pain when walking due to a significant artery blockage.I am currently receiving treatment.I have symptoms of poor blood flow in my legs.I have a confirmed cardiovascular disease.I experience leg pain when walking and my ABI test result is less than 0.85.I had a leg amputation above the ankle due to poor blood flow.I have had a heart attack before.I have had a stroke before.You have a body weight that is considered obese, with a BMI of 30 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: CagriSema 2.4 mg/2.4 mg
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cardiovascular Disease Patient Testimony for trial: Trial Name: NCT05669755 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential hazards do patients face while taking CagriSema 2.4 mg/2.4 mg?
"The safety of CagriSema 2.4 mg/2.4 mg is classified as 3, which reflects the comprehensive research conducted on it during its Phase 3 trials that proved both efficacy and safety."
Answered by AI
Is there availability for prospective individuals to participate in the experiment?
"Clinicaltrials.gov reveals that this trial, initially posted on March 1st 2023 and last revised on December 20th 2022, is not presently seeking candidates. Nonetheless, there are 917 other studies accepting participants at the present moment."
Answered by AI
Are there numerous facilities that are executing this research within the city boundaries?
"Currently, this clinical trial is welcoming enrolments from 67 different medical centres. Notable cities include Beverly Hills, Covina and La Jolla as well as 64 other locations. It is advised to look for the closest location in order to minimise travel needs should you choose to participate."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
North Carolina
California
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
0
1
3+
What site did they apply to?
Novo Nordisk Investigational Site
Other
Why did patients apply to this trial?
I like to try. Hoping to get off some of the meds I'm on. I've tried losing weight but haven't had any real loss for over 2 years.
PatientReceived 2+ prior treatments
I like the idea that I could help with medical trials, and help myself and others.
PatientReceived 2+ prior treatments
I have been obese for 6 years and need to avoid more damage to my joints. I have been unable to lose the weight.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long do screening visits take?
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Novo Nordisk Investigational Site: < 48 hours
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