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

NCT06692764 | Completed Phase 2 FDA Drug

• 1 other identifier: D7960C00009
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 26

Brief 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 ≥ 70 mg/dL, on stable medication.

Conditions

Atherosclerotic Cardiovascular Disease

Keywords

Ambulatory Blood Pressure.; Atherosclerotic Cardiovascular Disease.; Elevated Low-density Lipoprotein Cholesterol

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Week 4

• To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory nighttime average SBP at Week 4

  4 Weeks

• To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory daytime average SBP at Week 4

  4 Weeks

• To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory nighttime average DBP at Week 4

  4 Weeks

• To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory daytime average DBP at Week 4

  4 Weeks

Study Arms (2)

AZD0780

EXPERIMENTAL

Following randomization to treatment sequence, participants receive AZD0780 during period 1 or 2.

Drug: AZD0780

Placebo

PLACEBO COMPARATOR

Following randomization to treatment sequence, participants receive Placebo during period 1 or 2.

Drug: Placebo

Interventions

Placebo DRUG

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.

Placebo

AZD0780 DRUG

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.

AZD0780

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• \. Poorly controlled type 2 diabetes mellitus, defined as HbA1c \> 10% at screening.
• \. Participants with history of coronary artery bypass graft surgery ≤ 6 months prior to screening or percutaneous coronary intervention ≤ 3 months prior to screening.
• \. 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.
• \. Uncontrolled hypertension defined as average of triplicate seated SBP \> 160 mmHg or DBP \> 90 mmHg at screening.
• \. 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:
• (a) 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.
• \. 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.
• \. 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.
• \. 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Fortrea: collaborator

Study Sites (26)

Research Site

Inglewood, California, 90301, United States

Location

Research Site

Northridge, California, 91325, United States

Location

Research Site

Pomona, California, 91767, United States

Location

Research Site

Boca Raton, Florida, 33434, United States

Location

Research Site

Hialeah, Florida, 33012, United States

Location

Research Site

Jacksonville, Florida, 32216, United States

Location

Research Site

Miami, Florida, 33122, United States

Location

Research Site

Miami, Florida, 33165, United States

Location

Research Site

Miami, Florida, 33173, United States

Location

Research Site

Miami, Florida, 33174, United States

Location

Research Site

Ocala, Florida, 34474, United States

Location

Research Site

Port Orange, Florida, 32127, United States

Location

Research Site

Tamarac, Florida, 33321, United States

Location

Research Site

Chicago, Illinois, 60621, United States

Location

Research Site

Potomac, Maryland, 20854, United States

Location

Research Site

New Bedford, Massachusetts, 02740, United States

Location

Research Site

New Windsor, New York, 12553, United States

Location

Research Site

Beavercreek, Ohio, 45431, United States

Location

Research Site

Horsham, Pennsylvania, 19044, United States

Location

Research Site

Spartanburg, South Carolina, 29303, United States

Location

Research Site

Austin, Texas, 78704, United States

Location

Research Site

Dallas, Texas, 75230, United States

Location

Research Site

El Paso, Texas, 79905, United States

Location

Research Site

Hurst, Texas, 76054, United States

Location

Research Site

Mesquite, Texas, 75149, United States

Location

Research Site

Paris, Texas, 75462, United States

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 18, 2024
• Study Start: October 30, 2024
• Primary Completion: April 18, 2025
• Study Completion: May 2, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (26)