NCT07000357ClinicalTrials.gov

A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event

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Kurz gefasst

Phase 315.100 Teilnehmende gesucht1.452 Studienzentren36 Länder

Kategorien

Herz-Kreislauf100%

In 1 Register registriert

ClinicalTrials.govNCT07000357Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 4 Wochen

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2025-06-02; recorded start 2025-06-04
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 1365 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEGA

A very large study, international in scope: 15,100 participants (target), run at 1,452 sites, across 36 countries.

How this score is built

Enrolment39/40
15,100 participants (target)
Site count25/25
1,365 sites
Country count15/15
36 countries
Planned duration9/10
Planned over about 54 months
Sponsor scale10/10
AstraZeneca has led 991 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Zusammenfassung

The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.

Erkrankungen

Cardiovascular Disease

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

Inclusion Criteria: * Meets one of the following: 1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening Additional risk factors based on the level of the LDL-C and timing of MI or stroke: o Participants with an LDL-C ≥ 75 mg/dL (≥ 1.9 mmol/L) need to have at least one of the other additional risk factors (i to viii) below. ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD 2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii): (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases: 1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin/creatinine ratio ≥ 30 mg/g) and/or persistent eGFR \< 60 mL/min/1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening 2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist 3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist 4. ABI \< 0.9 or \> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance For (ii) and (iii), participants need to have at least one of the additional risk factors below:  1. CKD with eGFR x mL/min/1.73 m2 2. Current tobacco use 3. Age ≥ 65 4. T2DM (if included on the less significant atherosclerosis criterion iii) * Participants should receive a background lipid lowering regimen anticipated to achieve at least a \~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid). Participants must achieve a stable background lipid lowering therapy \> 28 days before screening. Exclusion criteria: * Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results. * Any revascularisation procedure planned within the next 3 months. * Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis. * Calculated eGFR \< 15 mL /min/1.73 m2 at screening. * Any laboratory values with the following deviations at screening: * AST or ALT \> 3 × ULN * TBL \> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \< 1.5 × ULN) * Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L). * Creatine kinase \> 5 × ULN * Urine albumin/creatinine ratio ≥ 500 mg/g * Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening. * Inadequately treated hypothyroidism defined as TSH \> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening. * Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study. * Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study. * Use of PCSK9 inhibitors: evolocumab/alirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	QUADRUPLE (4)
Teilnahme	15.100 Teilnehmende gesucht

Sponsor und Mitwirkende

AstraZeneca Sponsor

Studienarme und Interventionen

AZD0780EXPERIMENTAL
Participants will receive oral AZD0780 once daily
PlaceboPLACEBO_COMPARATOR
Participants will receive oral placebo once daily

Interventionen

Arzneimittel AZD0780
Participants will receive oral AZD0780 once daily
Arzneimittel Placebo
Participants will receive oral placebo once daily

Endpunkte

Primärer Endpunkt
Time to first event of any component of MACE-PLUS
To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MACE-PLUS (the composite of CV death, myocardial infarction \[MI\], ischaemic stroke, acute lower limb ischaemia, major amputation of a vascular aetiology, and urgent arterial revascularisation)
Zeitrahmen Up to approximately 54 months
Sekundärer Endpunkt
Time to first event of any component of 3P MACE
To compare the effect of treatment with AZD0780 to placebo in reducing the risk of 3-point (3P)-MACE (the composite of CV death, MI, and ischaemic stroke)
Zeitrahmen Up to approximately 54 months
Sekundärer Endpunkt
Time to first event of any component of MACE PLUS
To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MACE-PLUS in patients with a history of ASCVD
Zeitrahmen Up to approximately 54 months
Sekundärer Endpunkt
Time to first event of MI
To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MI
Zeitrahmen Up to approximately 54 months
Sekundärer Endpunkt
Time to first event of urgent coronary revascularisation
To compare the effect of treatment with AZD0780 to placebo in reducing the risk of urgent coronary revascularisation
Zeitrahmen Up to approximately 54 months
Sekundärer Endpunkt
Time to CV death
To compare the effect of treatment with AZD0780 to placebo in reducing the risk of CV death
Zeitrahmen Up to approximately 54 months
Sekundärer Endpunkt
Time to first event of MALE
To compare the effect of treatment with AZD0780 to placebo in reducing the risk of major adverse limb event (MALE) (the composite of acute lower limb ischaemia, major amputation of vascular aetiology, and urgent lower extremity revascularisation)
Zeitrahmen Up to approximately 54 months
Sekundärer Endpunkt
Time to all-cause mortality
To compare the effect of treatment with AZD0780 to placebo in reducing the risk of all-cause mortality
Zeitrahmen Up to approximately 54 months

Daten

Daten
Startdatum	4. Juni 2025 (tatsächlich)
Primärer Abschluss	26. Oktober 2029 (geschätzt)
Abschluss	26. Oktober 2029 (geschätzt)
Erstveröffentlichung	2. Juni 2025 (tatsächlich)
Zuletzt aktualisiert	24. August 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	August 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

1.106 Studienzentren rekrutieren

Argentina

Argentina
Einrichtung	Stadt	Status
Research Site	CABA	Rekrutiert
Research Site	CABA	Rekrutiert
Research Site	Capital Federal	Rekrutiert
Research Site	Ciudad Autonoma de Bs As	Rekrutiert
Research Site	Ciudad de Buenos Aires	Rekrutiert
Research Site	Ciudad de Buenos Aires	Rekrutiert
Research Site	Ciudad de Buenos Aires	Rekrutiert
Research Site	Ciudad de Buenos Aires	Rekrutiert
Research Site	Ciudad de Buenos Aires	Rekrutiert
Research Site	Ciudad de Rosario	Rekrutiert
Research Site	Córdoba	Rekrutiert
Research Site	Córdoba	Rekrutiert
Research Site	Córdoba	Rekrutiert
Research Site	Godoy Cruz	Rekrutiert
Research Site	Lanús Este	Rekrutiert
Research Site	Mar del Plata	Rekrutiert
Research Site	Nueva Córdoba	Rekrutiert
Research Site	Rosario	Rekrutiert
Research Site	Rosario	Rekrutiert
Research Site	Rosario	Rekrutiert
Research Site	Rosario	Rekrutiert
Research Site	San Juan	Rekrutiert
Research Site	San Miguel de Tucumán	Rekrutiert
Research Site	San Nicolás	Rekrutiert
Research Site	Santa Rosa	Rekrutiert
Research Site	Zárate	Rekrutiert

Brazil

Brazil
Einrichtung	Stadt	Status
Research Site	Aracaju	Rekrutiert
Research Site	Barretos	Rekrutiert
Research Site	Belo Horizonte	Rekrutiert
Research Site	Belo Horizonte	Rekrutiert
Research Site	Belo Horizonte	Rekrutiert
Research Site	Belém	Rekrutiert
Research Site	Blumenau	Rekrutiert
Research Site	Brasília	Rekrutiert
Research Site	Brasília	Rekrutiert
Research Site	Brasília	Rekrutiert
Research Site	Campina Grande do Sul	Rekrutiert
Research Site	Campinas	Rekrutiert
Research Site	Campinas	Rekrutiert
Research Site	Campinas	Rekrutiert
Research Site	Campinas	Rekrutiert
Research Site	Criciúma	Rekrutiert
Research Site	Curitiba	Zurückgezogen
Research Site	Curitiba	Rekrutiert
Research Site	Curitiba	Rekrutiert
Research Site	Goiânia	Rekrutiert
Research Site	Juiz de Fora	Rekrutiert
Research Site	Marília	Rekrutiert
Research Site	Natal	Rekrutiert
Research Site	Ponta Grossa	Rekrutiert

1.402 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

24. August 2026
Studienzentrum hinzugefügt
87 sites added (1452 total)
13651452

https://xmedica.io/trials/ctgov/NCT07000357