Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Phase 3
Not yet recruiting
- Conditions
- Atherosclerotic Cardiovascular DiseaseOverweightObesity
- Interventions
- Drug: Placebo
- Registration Number
- NCT07037433
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 12800
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maridebart Cafraglutide Maridebart Cafraglutide Participants will receive maridebart cafraglutide subcutaneously (SC). Placebo Placebo Participants will receive placebo SC.
- Primary Outcome Measures
Name Time Method Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, Myocardial Infarction (MI), or Ischemic Stroke (3-point Major Adverse Cardiac Events [3-P MACE]) Up to approximately 35 months Time to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, MI, Ischemic Stroke, Coronary Revascularization, or Heart Failure (HF) Event (5-point MACE) Up to approximately 35 months
- Secondary Outcome Measures
Name Time Method Change from Baseline in Waist Circumference at Week 72 Baseline and Week 72 Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or HF Event Up to approximately 35 months Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke or Coronary Revascularization Up to approximately 35 months Time to First MI Up to approximately 35 months Time to First Ischemic Stroke Up to approximately 35 months Time to CV Death Up to approximately 35 months Time to All-cause Death Up to approximately 35 months Time to First Coronary Revascularization Up to approximately 35 months Time to First HF Event Up to approximately 35 months Time to First HF Event or CV Death Up to approximately 35 months Time to First Unstable Angina Requiring Hospitalization Up to approximately 35 months Time to First Occurrence of MI or CV Death Up to approximately 35 months Time to First Occurrence of MI, Ischemic Stroke or All-cause Death Up to approximately 35 months Total Major Ischemic Events (Time to First and Recurrent MI or Ischemic Stroke) Up to approximately 35 months Total All-cause Hospitalizations (Time to First and Recurrent Event) Up to approximately 35 months Time to Onset of Type 2 Diabetes Mellitus (T2DM) in Participants with Prediabetes at Baseline Up to approximately 35 months Time to Onset of T2DM in Participants without T2DM at Baseline Up to approximately 35 months Change from Baseline in Systolic Blood Pressure (SBP) at Week 72 Baseline and Week 72 Change from Baseline in Diastolic Blood Pressure (DBP) at Week 72 Baseline and Week 72 Change from Baseline in Body Mass Index (BMI) at Week 72 Baseline and Week 72 Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72 Baseline and Week 72 Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72 Baseline and Week 72 Change from Baseline in Fasting Plasma Glucose at Week 72 Baseline and Week 72 Percent Change from Baseline in High-sensitivity C-reactive protein (hs-CRP) at Week 72 Baseline and Week 72 Percent Change from Baseline in Body Weight at Week 72 Baseline and Week 72 Percent Change from Baseline in Total Cholesterol at Week 72 Baseline and Week 72 Percent Change from Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 72 Baseline and Week 72 Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 72 Baseline and Week 72 Percent Change from Baseline in Triglycerides (TG) at Week 72 Baseline and Week 72 Number of Participants at Week 72 with HbA1c < 6.5% (48 mmol/mol) in Participants with T2DM at Baseline Baseline and Week 72 Number of Participants at Week 72 with HbA1c < 6.0% (42 mmol/mol) in Participants with T2DM at Baseline Baseline and Week 72 Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants with T2DM at Baseline Baseline and Week 72 Number of Participants at Week 72 with HbA1c < 6.5% (48 mmol/mol) in Participants Without T2DM at Baseline Baseline and Week 72 Number of Participants at Week 72 with HbA1c < 6.0% (42 mmol/mol) in Participants Without T2DM at Baseline Baseline and Week 72 Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants Without T2DM at Baseline Baseline and Week 72 Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants with HbA1c ≥ 5.7% and < 6.5% at Baseline Baseline and Week 72 Change from Baseline in Short Form 36 Health Survey Acute Version 2 (SF-36 v2) Physical Function Domain Score at Week 48 Baseline and Week 48 Time to First Event of a Composite Nephropathy Endpoint Up to approximately 35 months Composite endpoint consists of onset of persistent macroalbuminuria, persistent ≥ 40% reduction in estimated glomerular filtration rate (eGFR), onset of persistent eGFR \< 15 mL/min/1.73 m2, initiation of chronic renal replacement therapy (dialysis or transplantation), CV or renal death.
Change in eGFR (total slope) for the period from baseline to the final follow up visit Baseline up to approximately 35 months Change in eGFR (chronic slope) for the period from 4 months to the final follow-up visit From 4 months up to approximately 35 months Time to First Occurrence of a Major Adverse Limb Event (MALE) Defined as Acute Limb Ischemia, Urgent Peripheral Revascularization, Major Amputation Due to a Vascular Etiology or Chronic Limb-threatening Ischemia Requiring Revascularization Up to approximately 35 months Total Arterial (Coronary, Cerebrovascular, and Peripheral) Revascularization Procedures (Time to First and Recurrent Event) Up to approximately 35 months Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, MALE, or Arterial Revascularization Up to approximately 35 months Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or Acute Limb Ischemia Up to approximately 35 months Time to First Occurrence of a Composite Endpoint Consisting of CV Death, MI, Ischemic Stroke, Acute Limb Ischemia, or Urgent Arterial Revascularization Procedure (Coronary, Cerebrovascular or Peripheral) Up to approximately 35 months Number of Participants with Treatment-emergent Adverse Events Up to approximately 35 months Number of Participants with Serious Adverse Events Up to approximately 35 months Plasma Concentration of Maridebart Cafraglutide at Week 72 Week 72
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of GLP-1 receptor agonism in cafraglutide improve CV outcomes in atherosclerotic disease?
How does cafraglutide's efficacy compare to other GLP-1 agonists in reducing CV events in obese patients with ASCVD?
Which biomarkers correlate with cafraglutide response in patients with metabolic syndrome and atherosclerosis?
What adverse event profiles are associated with cafraglutide in high-risk CV populations with obesity?
How do SGLT2 inhibitors and cafraglutide compare in managing weight and CV risk in patients with atherosclerosis?