Atherosclerotic Cardiovascular DiseasePhase 2AZD0780-ABPMNCT06692764

A Study to Assess the Effect of AZD0780 on Ambulatory Blood Pressure

A Phase 2 study testing AZD0780 in people with Atherosclerotic Cardiovascular Disease, run by AstraZeneca at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase II, multi-centre, randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of AZD0780 Dose 1 versus placebo on systolic blood pressure (SBP) at Week 4, as measured by 24-hour ambulatory blood pressure monitoring (ABPM) in participants with ASCVD or risk equivalents and LDL-C… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atherosclerotic Cardiovascular Disease
What is being tested?: AZD0780
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 202 participants
Where: 26 sitesUnited States
Study dates: 30 Oct 2024to 2 May 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant must be ≥ 18 years of age at the time of signing the informed consent.
Participants with a history of ASCVD defined as myocardial infarction, stroke, or symptomatic peripheral arterial disease, or with risk factors hereof.
Participants with a fasting serum LDL-C ≥ 70 mg/dL (1.8 mmol/L) at screening.
Should be receiving stable SoC therapy for their comorbidities for at least 4 weeks prior to screening. There should be no planned medication or dose changes during study participation.
Body mass index ≥ 19.0 kg/m2.
Sex: males and females (females of non-childbearing potential).

Who cannot join

eGFR < 45 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (2021) at screening.
History or presence of gastrointestinal, hepatic, or renal disease, or any other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
4. Poorly controlled type 2 diabetes mellitus, defined as HbA1c > 10% at screening.
5. Participants with history of coronary artery bypass graft surgery ≤ 6 months prior to screening or percutaneous coronary intervention ≤ 3 months prior to screening.
6. Heart failure with New York Heart Association Class III to IV. 9. Low-density protein or plasma apheresis within 12 months prior to Period 1 Day -1.
10. Uncontrolled hypertension defined as average of triplicate seated SBP > 160 mmHg or DBP > 90 mmHg at screening.

Show all 17Show fewer

11. Pulse rate after 10 minutes seated rest < 50 or > 100 bpm at screening. 12. Any laboratory values with the following deviations at screening; test may be repeated at the discretion of the investigator if abnormal:
Any positive result on screening for hepatitis B, hepatitis C, or HIV; (b) ALT > 1.5 × ULN; (c) AST > 1.5 × ULN; (d) TBL > ULN; (e) Haemoglobin < 12 g/dL in males or < 11 g/dL in females; (f) Potassium < lower limit of normal. 13. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG as judged by the investigator, including:
family history of long QT syndrome;
PR interval prolongation > 240 ms;
QTcF > 450 ms; (> 470 ms in participants with bundle branch block)
any intermittent or persistent high degree atrioventricular-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias requiring treatment.
18. Lomitapide within 12 months prior to Period 1 Day -1. 19. Current or previous treatment with drugs for reduction or inhibition of PCSK9 (approved or investigational, eg, evolocumab, alirocumab, or inclisiran) within 12 months prior to Period 1 Day -1.
20. Fibrate therapy and derivatives are prohibited. 21. Receiving or has received within 14 days of screening, medication that contains a black box warning for significant QT prolongation. A list of prohibited medications can be found in Appendix G.
22. Nutraceuticals or homeopathic treatments which may have an impact on BP. 26. Participants working 3rd shift or night shifts based on potential changes in circadian rhythm.
27. Participants with sleep disorders that would affect ABPM measurements, in the investigator's opinion.
28. Participant arm circumference not appropriate for available ABPM cuff circumference, or participant has a medical device (eg, continuous glucose monitor) that prevents use of the ABPM device, in the opinion of the investigator.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Research Site
Austin, Texas, 78704
Research Site
Beavercreek, Ohio, 45431
Research Site
Boca Raton, Florida, 33434
Research Site
Chicago, Illinois, 60621
Research Site
Dallas, Texas, 75230
Research Site
El Paso, Texas, 79905
Research Site
Hialeah, Florida, 33012
Research Site
Horsham, Pennsylvania, 19044
Research Site
Hurst, Texas, 76054
Research Site
Inglewood, California, 90301
Research Site
Jacksonville, Florida, 32216
Research Site
Mesquite, Texas, 75149
Research Site
Miami, Florida, 33122
Research Site
Miami, Florida, 33165
Research Site
Miami, Florida, 33173
Research Site
Miami, Florida, 33174
Research Site
New Bedford, Massachusetts, 02740
Research Site
New Windsor, New York, 12553
Research Site
Northridge, California, 91325
Research Site
Ocala, Florida, 34474
Research Site
Paris, Texas, 75462
Research Site
Pomona, California, 91767
Research Site
Port Orange, Florida, 32127
Research Site
Potomac, Maryland, 20854
Research Site
Spartanburg, South Carolina, 29303
Research Site
Tamarac, Florida, 33321

Other trials in United States

About this study

Official title: A Phase II Study to Assess the Effect of AZD0780 on Ambulatory Blood Pressure in Participants With Atherosclerotic Cardiovascular Disease or Risk Equivalents and Elevated Low-Density Lipoprotein Cholesterol

Read the detailed description

Approximately 30 sites in the United Sites will enroll adult participants with Atherosclerotic Cardiovascular Disease or Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol.

Eligible participants will be randomized (1:1) on Period One (1) Day One (1) to One (1) of Two (2) treatment sequences.

Potential participants will be screened to assess their eligibility to enter the study up to 7 days prior to first administration of study intervention. Eligible participants will be randomized to Treatment Sequence AB or BA on Period One (1) Day One (1). A 14-day washout period will be required between the final dose in Period One (1) and start of baseline ABPM in Period Two (2).

In Periods One (1) and Two (2), participants will return to the study site for an outpatient visit (OPV) on Day -1 for the start of the baseline ABPM. The ABPM device will be worn for 25 hours. Participants will return to the study site for an OPV on the following day (Day 1) for removal of the ABPM device and to begin self-administration of AZD0780 or placebo for 29 ± 2 days as per the randomization scheme. First dose of study intervention will be taken after the ABPM device is removed on Day 1 at the study site after the baseline ABPM is qualified (i.e., determined not to require repeat). Additional OPVs will be required on Days 14 (± 2 days), 28 (± 2 days), and 29 (day after Day 28 [± 2 days]). On Days 28 and 29 of each period, the ABPM device will be worn for 25 hours. Study intervention will continue to be taken on each day after the start of Week 4 (Days 28 and 29) 24-hour ABPM for Periods 1 and 2 until a qualified ABPM is obtained. Only 1 repeat may be attempted within 2 days of the end of the first ABPM attempt. Participants will return to the study site for a follow-up visit 14 (± 2) days after the last dose of study intervention in Period Two (2).

Serial pharmacokinetic blood samples will be collected predose and up to 7 hours postdose on Day 14 and predose on Day 28 in each period. Monitoring of adverse events, vital sign measurements, 12-lead electrocardiograms, clinical laboratory tests, and physical examinations will be performed to assess safety and tolerability.

Conditions: Atherosclerotic Cardiovascular Disease
Being tested: Placebo, AZD0780
Keywords: Ambulatory Blood Pressure., Atherosclerotic Cardiovascular Disease., Elevated Low-density Lipoprotein Cholesterol
Medical subject headings: Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
0 mg (Placebo). Participants will receive three bottles, each containing 35 tablets with placebo tablets.
Participants will take 1 tablet from each bottle on each scheduled day of study intervention, which will provide the placebo dose.
AZD0780Drug
Dose 1 Participants will receive three bottles, each containing 35 tablets:
- 1 bottle of dose a AZD0780 tablets
- 1 bottle of dose b AZD0780 tablets
- 1 bottle of dose c AZD0780 tablets Participants will take 1 tablet from each bottle on each scheduled day of study intervention, which will provide the AZD0780 dose.

Study groups in NCT06692764
Study group	Role	What they receive
AZD0780	Experimental	Following randomization to treatment sequence, participants receive AZD0780 during period 1 or 2. Receives: Drug: AZD0780
Placebo	Placebo comparator	Following randomization to treatment sequence, participants receive Placebo during period 1 or 2. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory 24-hour average SBP at Week 4
Change from baseline in ambulatory 24-hour average systolic blood pressure (SBP) at Week 4
Measured: Week 4

Secondary outcomes (5)

To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory 24-hour average DBP at Week 4
Change from baseline in ambulatory 24-hour average diastolic blood pressure (DBP) at Week 4
Measured: Week 4
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory nighttime average SBP at Week 4
Change from baseline in ambulatory nighttime average systolic blood pressure (SBP) at Week 4
Measured: 4 Weeks
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory daytime average SBP at Week 4
Change from baseline in ambulatory daytime average systolic blood pressure (SBP) at Week 4
Measured: 4 Weeks
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory nighttime average DBP at Week 4
Change from baseline in ambulatory nighttime average diastolic blood pressure (DBP) at Week 4
Measured: 4 Weeks
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory daytime average DBP at Week 4
Change from baseline in ambulatory daytime average diastolic blood pressure (DBP) at Week 4
Measured: 4 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 20242 May 2025

First posted18 Nov 2024
Study start30 Oct 2024
Primary completion18 Apr 2025
Study completion2 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Potential participants will be screened to assess their eligibility to enter the study up to 7 days prior to first administration of study intervention. Eligible participants will be randomized to Treatment Sequence AB or BA on Period 1 Day 1. A 14-day washout period will be required between the final dose in Period 1 and start of baseline ABPM in Period 2. In Periods 1 and 2, participants will return to the study site for an OPV on Day -1 for the start of the baseline ABPM. The ABPM device will be worn for 25 hours. Participants will return to the study site for an OPV on the following day (Day 1) for removal of the ABPM device and to begin self-administration of AZD0780 or placebo for 29 ± 2 days as per the randomization scheme. First dose of study intervention will be taken after the ABPM device is removed on Day 1 at the study site after the baseline ABPM is qualified (i.e., determined not to require repeat).
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06692764
Sponsor's protocol ID: D7960C00009
Acronym: AZD0780-ABPM
Status last verified: Feb 2026
First submitted: 28 Oct 2024
Last updated: 18 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study to Assess the Effect of AZD0780 on Ambulatory Blood Pressure in Participants With Atherosclerotic Cardiovascular Disease or Risk Equivalents and Elevated Low-Density Lipoprotein Cholesterol
ClinicalTrials.gov ID: NCT06692764
Acronym / sponsor ID: AZD0780-ABPM / D7960C00009
Conditions: Atherosclerotic Cardiovascular Disease
Keywords: Ambulatory Blood Pressure., Atherosclerotic Cardiovascular Disease., Elevated Low-density Lipoprotein Cholesterol
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Fortrea
Study start: 30 Oct 2024 (actual)
Primary completion: 18 Apr 2025 (actual)
Study completion: 2 May 2025 (actual)
First posted: 18 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Approximately 30 sites in the United Sites will enroll adult participants with Atherosclerotic Cardiovascular Disease or Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol.

Eligible participants will be randomized (1:1) on Period One (1) Day One (1) to One (1) of Two (2) treatment sequences.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Potential participants will be screened to assess their eligibility to enter the study up to 7 days prior to first administration of study intervention. Eligible participants will be randomized to Treatment Sequence AB or BA on Period 1 Day 1. A 14-day washout period will be required between the final dose in Period 1 and start of baseline ABPM in Period 2. In Periods 1 and 2, participants will return to the study site for an OPV on Day -1 for the start of the baseline ABPM. The ABPM device will be worn for 25 hours. Participants will return to the study site for an OPV on the following day (Day 1) for removal of the ABPM device and to begin self-administration of AZD0780 or placebo for 29 ± 2 days as per the randomization scheme. First dose of study intervention will be taken after the ABPM device is removed on Day 1 at the study site after the baseline ABPM is qualified (i.e., determined not to require repeat).

Arm	Type	Receives
AZD0780	Experimental	Drug: AZD0780Following randomization to treatment sequence, participants receive AZD0780 during period 1 or 2.
Placebo	Placebo comparator	Drug: PlaceboFollowing randomization to treatment sequence, participants receive Placebo during period 1 or 2.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Participant must be ≥ 18 years of age at the time of signing the informed consent.
Participants with a history of ASCVD defined as myocardial infarction, stroke, or symptomatic peripheral arterial disease, or with risk factors hereof.
Participants with a fasting serum LDL-C ≥ 70 mg/dL (1.8 mmol/L) at screening.
Should be receiving stable SoC therapy for their comorbidities for at least 4 weeks prior to screening. There should be no planned medication or dose changes during study participation.
Body mass index ≥ 19.0 kg/m2.

Key exclusion criteria (17 listed)

eGFR < 45 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (2021) at screening.
History or presence of gastrointestinal, hepatic, or renal disease, or any other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
4. Poorly controlled type 2 diabetes mellitus, defined as HbA1c > 10% at screening.
5. Participants with history of coronary artery bypass graft surgery ≤ 6 months prior to screening or percutaneous coronary intervention ≤ 3 months prior to screening.
6. Heart failure with New York Heart Association Class III to IV. 9. Low-density protein or plasma apheresis within 12 months prior to Period 1 Day -1.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo0 mg (Placebo). Participants will receive three bottles, each containing 35 tablets with placebo tablets. Participants will take 1 tablet from each bottle on each scheduled day of study intervention, which will provide the placebo dose.	Drug	Placebo
AZD0780Dose 1 Participants will receive three bottles, each containing 35 tablets: * 1 bottle of dose a AZD0780 tablets * 1 bottle of dose b AZD0780 tablets * 1 bottle of dose c AZD0780 tablets Participants will take 1 tablet from each bottle on each scheduled day of study intervention, which will provide the AZD0780 dose.	Drug	AZD0780

Primary outcome

To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory 24-hour average SBP at Week 4
Time frame: Week 4
Change from baseline in ambulatory 24-hour average systolic blood pressure (SBP) at Week 4

5 secondary outcomes

To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory 24-hour average DBP at Week 4
Time frame: Week 4
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory nighttime average SBP at Week 4
Time frame: 4 Weeks
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory daytime average SBP at Week 4
Time frame: 4 Weeks
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory nighttime average DBP at Week 4
Time frame: 4 Weeks
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory daytime average DBP at Week 4
Time frame: 4 Weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD0780 in people with Atherosclerotic Cardiovascular Disease, run by AstraZeneca at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory 24-hour average SBP at Week 4 (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06692764.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.