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Completed

NCT Number: NCT06173570

A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia

The primary purpose of this study is to measure the effect of different daily doses of AZD0780 on Low-Density Lipoprotein (LDL-C) levels compared with placebo in participants with dyslipidemia. The effect of AZD0780 versus placebo on other lipid parameters and inflammatory markers is also investigated. The concentration of AZD0780 in blood at specific timepoints is measured, and the safety and tolerability of AZD0780 will be evaluated. There is a follow-up after end of treatment, but expanded access is not available. The primary hypothesis is that at least one of the investigated doses of AZD0780 is superior to placebo in lowering LDL-C level, in percent change from baseline up to week 12.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Barrie, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males, and females of non-childbearing potential 18 to 75 years of age, inclusive, at the time of signing the informed consent.
  • Participants with a fasting low-density lipoprotein cholesterol (LDL-C) higher than or equal to 70 mg/dL (1.8 mmol/L) and lower than 190 mg/dL (4.9 mmol/L) at screening.
  • Participants with fasting triglycerides lower than 400 mg/dL (lower than 4.52 mmol/L) at screening.
  • Should be receiving moderate or high-intensity statin therapy for more than or equal to 2 months prior to screening.
  • There should be no planned medication or dose change during study participation.
  • Body mass index at or above 19.0 kg/m^2.

Exclusion criteria

  • History or presence of gastrointestinal, hepatic or renal disease or any other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • Any uncontrolled or serious disease, or any medical (e.g., known major active infection or major hematological, renal, metabolic, gastrointestinal, respiratory, or endocrine dysfunction) or surgical condition that, in the opinion of the investigator, may either interfere with participation in the clinical study and/or put the participant at significant risk.
  • Poorly controlled type 2 diabetes mellitus, defined as hemoglobin A1c (HbA1c) greater than 10 percent at screening.
  • Acute ischemic cardiovascular event in the last 12 months.
  • Heart failure with New York Heart Association (NYHA) Class III-IV.
  • Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or Stage 1 prostate carcinoma) within the last 10 years.
  • Recipient of any major organ transplant, e.g., lung, liver, heart, bone marrow, renal.
  • LDL or plasma apheresis within 12 months prior to randomization.
  • Uncontrolled hypertension.
  • Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG as judged by the investigator.

Treatment and study plan

AZD0780

Drug

AZD0780 administered orally, once daily for 12 weeks

Placebo

Drug

Placebo administered orally, once daily for 12 weeks

Primary outcomes

  1. Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Level From Baseline to Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 LDL-C - Baseline LDL-C) / Baseline LDL-C * 100. Negative values indicate reduction in LDL-C. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.

Secondary outcomes

  1. Percent Change From Baseline of Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 LDL-C - Baseline LDL-C) / Baseline LDL-C * 100. Negative values indicate reduction in LDL-C. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.

  2. Percent Change From Baseline of Total Cholesterol at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.

  3. Percent Change From Baseline of High-Density Lipoprotein Cholesterol (HDL-C) at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.

  4. Percent Change From Baseline of Triglycerides at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.

  5. Percent Change From Baseline of Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.

  6. Percent Change From Baseline of Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.

  7. Percent Change From Baseline of Apolipoprotein A1 at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.

  8. Percent Change From Baseline of Apolipoprotein B at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.

  9. Percent Change From Baseline of Total Cholesterol at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.

  10. Percent Change From Baseline of High-Density Lipoprotein Cholesterol (HDL-C) at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.

  11. Percent Change From Baseline of Triglycerides at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.

  12. Percent Change From Baseline of Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.

  13. Percent Change From Baseline of Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.

  14. Percent Change From Baseline of Apolipoprotein A1 at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.

  15. Percent Change From Baseline of Apolipoprotein B at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.

  16. Percent Change From Baseline of Lipoprotein-a at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Descriptive statistics only.

  17. Percent Change From Baseline of Remnant Cholesterol at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Descriptive statistics only.

  18. Percent Change From Baseline of High Sensitivity C-reactive Protein (hsCRP) at Week 12

    Time frame: From first day of treatment up to week 12

    Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Descriptive statistics only.

  19. AZD0780 Plasma Concentrations Summarized by Sampling Timepoint

    Time frame: From week 1 up to week 12

    Geometric mean plasma concentration; LLOQ = 0.01 umol/L; BLQ values are handled as Not Quantified (NQ)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase IIb, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AZD0780 in Participants With Dyslipidemia

Acronym: PURSUIT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2023
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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