DelfaGLP-1 Atlas

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MARITIME-CV

RecruitingPhase 3

Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

772

Recruiting sites

770

Enrollment

12,800

estimated

Study population

Cardiovascular disease, Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoints

•3-point MACE (Cardiovascular death, Non-fatal MI, Ischemic stroke)•5-point MACE (All-cause death, Non-fatal MI, Ischemic stroke, Coronary revascularization)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07037433
Org study ID20220196

Timeline

Milestones

Study first posted2025-06-25actual
Study start2025-07-25actual
Last update posted2026-05-29actual
Primary completion2028-06-30estimated
Study completion2030-09-29estimated

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Study populations

Who this study enrolls

Cardiovascular diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age45 Years
Maximum age99 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age ≥ 45 years at screening.
•BMI of ≥ 27.0 kg/m^2 at screening.
•History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following:
–Prior MI (presumed atherothrombotic event due to plaque rupture/erosion).
–Prior ischemic stroke (presumed due to atherosclerosis; may include ischemic stroke with hemorrhagic transformation).
–Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) < 0.9 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease.

Exclusion criteria

•History of any of the following within 60 days before screening or between screening and randomization: MI, hospitalization for unstable angina, arterial revascularization (eg, coronary, cerebrovascular or peripheral) major cardiovascular surgery, stroke, or transient ischemic attack (TIA).
•New York Heart Association (NYHA) class IV HF during screening or hospitalization for HF within 60 days before screening or between screening and randomization.
•Type 1 DM, or any other type of diabetes with the exception of T2DM or prior gestational diabetes. Participants with a history of gestational diabetes should be stratified according to their current diabetes classification.
•For participants with T2DM (including those without a prior history of T2DM but with a HbA1c ≥ 6.5% during screening):
–HbA1c > 10.0% (86 mmol/mol) at screening.
–History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization.
–One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness.
–History of proliferative diabetic retinopathy, diabetic maculopathy, severe non-proliferative diabetic retinopathy, or currently receiving or planning to receive treatment for diabetic retinopathy and/or diabetic macular edema.
•Use of any glucagon-like peptide-1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days before randomization or planned use during the conduct of the trial.
•History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening or between screening and randomization.
•Family (first-degree relative[s]), or personal history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN-2).
•Calcitonin ≥ 50 ng/L (pg/mL) at screening.
•Acute or chronic hepatitis; signs and symptoms of any liver disease other than metabolic dysfunction-associated steatotic liver disease, or alanine aminotransferase (ALT) > 3.0 x the upper limit of normal (ULN) during screening, or total bilirubin (TBL) > 1.8 x ULN during screening (for participants with a known diagnosis of Gilbert syndrome, direct bilirubin should be used instead of TBL).
•History of malignancy within the last 5 years before screening or between screening and randomization (except for the following treated with curative intent: non-melanoma skin cancer, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ).
•Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment.

Endpoints (50)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes
20
Glycemic / diabetes
11
Cardiometabolic biomarkers
7
Renal / kidney
4
Weight & body composition
3
Safety / tolerability / PK
3
Heart failure
1
Patient-reported / QoL
1

Cardiovascular outcomes

20 endpoints
Primary/protocol endpoint

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])

Time frame:Up to approximately 35 months

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Ischemic stroke

Primary/protocol endpoint

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)

Time frame:Up to approximately 35 months

5-point MACE

time to event, event

componentsAll-cause death, Non-fatal MI, Ischemic stroke, Coronary revascularization, Heart-failure hospitalization

Secondary/protocol endpoint

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or HF Event

Time frame:Up to approximately 35 months

4-point MACE

time to event, event

componentsCardiovascular death, Myocardial infarction (any), Ischemic stroke, Heart-failure hospitalization

Secondary/protocol endpoint

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke or Coronary Revascularization

Time frame:Up to approximately 35 months

4-point MACE

time to event, event

componentsCardiovascular death, Myocardial infarction (any), Ischemic stroke, Coronary revascularization

Secondary/protocol endpoint

Time to First MI

Time frame:Up to approximately 35 months

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Secondary/protocol endpoint

Time to First Ischemic Stroke

Time frame:Up to approximately 35 months

Ischemic stroke

time to event, event

SNOMED 230690007

Secondary/protocol endpoint

Time to CV Death

Time frame:Up to approximately 35 months

Cardiovascular death

time to event, event

Secondary/protocol endpoint

Time to All-cause Death

Time frame:Up to approximately 35 months

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Time to First Coronary Revascularization

Time frame:Up to approximately 35 months

Coronary revascularization

time to event, event

SNOMED 415070008

Secondary/protocol endpoint

Time to First HF Event or CV Death

Time frame:Up to approximately 35 months

Expanded / custom MACE composite

time to event, event

componentsHeart-failure hospitalization, Cardiovascular death

Secondary/protocol endpoint

Time to First Unstable Angina Requiring Hospitalization

Time frame:Up to approximately 35 months

Unstable angina hospitalization

time to event, event

Secondary/protocol endpoint

Time to First Occurrence of MI or CV Death

Time frame:Up to approximately 35 months

Expanded / custom MACE composite

time to event, event

componentsMyocardial infarction (any), Cardiovascular death

Secondary/protocol endpoint

Time to First Occurrence of MI, Ischemic Stroke or All-cause Death

Time frame:Up to approximately 35 months

Expanded / custom MACE composite

time to event, event

componentsMyocardial infarction (any), Ischemic stroke, All-cause death

Secondary/protocol endpoint

Total Major Ischemic Events (Time to First and Recurrent MI or Ischemic Stroke)

Time frame:Up to approximately 35 months

CV events (total recurrent)

event count, event

componentsMyocardial infarction (any), Ischemic stroke

Secondary/protocol endpoint

Total All-cause Hospitalizations (Time to First and Recurrent Event)

Time frame:Up to approximately 35 months

All-cause hospitalization

event count, event

Secondary/protocol endpoint

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

Time frame:Up to approximately 35 months

MALE composite (major adverse limb events)

time to event, event

componentsAcute limb ischemia, Peripheral revascularization, Major amputation

Secondary/protocol endpoint

Total Arterial (Coronary, Cerebrovascular, and Peripheral) Revascularization Procedures (Time to First and Recurrent Event)

Time frame:Up to approximately 35 months

CV events (total recurrent)

event count, event

componentsCoronary revascularization, Cerebrovascular revascularization, Peripheral revascularization

Secondary/protocol endpoint

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, MALE, or Arterial Revascularization

Time frame:Up to approximately 35 months

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, Myocardial infarction (any), Ischemic stroke, MALE composite (major adverse limb events), Coronary revascularization, Cerebrovascular revascularization, Peripheral revascularization

Secondary/protocol endpoint

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or Acute Limb Ischemia

Time frame:Up to approximately 35 months

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, Myocardial infarction (any), Ischemic stroke, Acute limb ischemia

Secondary/protocol endpoint

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)

Time frame:Up to approximately 35 months

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, Myocardial infarction (any), Ischemic stroke, Acute limb ischemia, Coronary revascularization, Cerebrovascular revascularization, Peripheral revascularization

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI) at Week 72

Time frame:Baseline and Week 72

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference at Week 72

Time frame:Baseline and Week 72

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight at Week 72

Time frame:Baseline and Week 72

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

11 endpoints
Secondary/protocol endpoint

Time to Onset of Type 2 Diabetes Mellitus (T2DM) in Participants with Prediabetes at Baseline

Time frame:Up to approximately 35 months

Time to T2DM onset

time to event, event

Secondary/protocol endpoint

Time to Onset of T2DM in Participants without T2DM at Baseline

Time frame:Up to approximately 35 months

Time to T2DM onset

time to event, event

Secondary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72

Time frame:Baseline and Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in Fasting Plasma Glucose at Week 72

Time frame:Baseline and Week 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Number of Participants at Week 72 with HbA1c < 6.5% (48 mmol/mol) in Participants with T2DM at Baseline

Time frame:Baseline and Week 72

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants at Week 72 with HbA1c < 6.0% (42 mmol/mol) in Participants with T2DM at Baseline

Time frame:Baseline and Week 72

HbA1c <6.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants with T2DM at Baseline

Time frame:Baseline and Week 72

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants at Week 72 with HbA1c < 6.5% (48 mmol/mol) in Participants Without T2DM at Baseline

Time frame:Baseline and Week 72

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants at Week 72 with HbA1c < 6.0% (42 mmol/mol) in Participants Without T2DM at Baseline

Time frame:Baseline and Week 72

HbA1c <6.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants Without T2DM at Baseline

Time frame:Baseline and Week 72

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants with HbA1c ≥ 5.7% and < 6.5% at Baseline

Time frame:Baseline and Week 72

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Heart failure

1 endpoint
Secondary/protocol endpoint

Time to First HF Event

Time frame:Up to approximately 35 months

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Renal / kidney

4 endpoints
Secondary/protocol endpoint

Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72

Time frame:Baseline and Week 72

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

Time to First Event of a Composite Nephropathy Endpoint

Time frame:Up to approximately 35 months

Custom renal composite

time to event, event

componentsuACR, change, eGFR, change, End-stage renal disease, Kidney-replacement therapy, Cardiovascular death, Renal death

Secondary/protocol endpoint

Change in eGFR (total slope) for the period from baseline to the final follow up visit

Time frame:Baseline up to approximately 35 months

eGFR slope (total)

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in eGFR (chronic slope) for the period from 4 months to the final follow-up visit

Time frame:From 4 months up to approximately 35 months

eGFR slope (chronic)

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

7 endpoints
Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP) at Week 72

Time frame:Baseline and Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from Baseline in Diastolic Blood Pressure (DBP) at Week 72

Time frame:Baseline and Week 72

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Percent Change from Baseline in High-sensitivity C-reactive protein (hs-CRP) at Week 72

Time frame:Baseline and Week 72

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Percent Change from Baseline in Total Cholesterol at Week 72

Time frame:Baseline and Week 72

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percent Change from Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 72

Time frame:Baseline and Week 72

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 72

Time frame:Baseline and Week 72

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Percent Change from Baseline in Triglycerides (TG) at Week 72

Time frame:Baseline and Week 72

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Short Form 36 Health Survey Acute Version 2 (SF-36 v2) Physical Function Domain Score at Week 48

Time frame:Baseline and Week 48

SF-36 physical

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Number of Participants with Treatment-emergent Adverse Events

Time frame:Up to approximately 35 months

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants with Serious Adverse Events

Time frame:Up to approximately 35 months

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Plasma Concentration of Maridebart Cafraglutide at Week 72

Time frame:Week 72

Plasma concentration (steady state)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.