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

NCT06173570
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Phase
Phase 2
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Recruitment status
Completed
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Participants
428
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Lead sponsor
AstraZeneca
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Start date
2024-01-19
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Number of sites
55
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Summary
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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Acronym
PURSUIT
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Short title
A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia
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Official 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
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Control arm
Placebo
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2024-09-30
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First posted
2023-12-15
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Registry last updated
2025-11-17
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Primary completion date
2024-09-30
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Start date
2024-01-19
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Actual participants
428
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Participants
428
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Participant count basis
Actual
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Protocol amendments
4
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Number of sites
55
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06173570
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ClinicalTrials.gov ID
NCT06173570
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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.

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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: From week 1 up to week 12

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
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  • Research SiteHuntsville, United States
  • Research SiteLincoln, United States
  • Research SitePalm Springs, United States
  • Research SiteSanta Ana, United States
  • Research SiteBoca Raton, United States
  • Research SiteHialeah, United States
  • Research SiteInverness, United States
  • Research SiteJacksonville, United States
  • Research SiteIndianapolis, United States
  • Research SiteLouisville, United States
  • Research SiteNew Windsor, United States
  • Research SiteGreensboro, United States
  • Research SiteFargo, United States
  • Research SiteSan Marcos, United States
  • Research SiteBarrie, Canada
  • Research SiteBrampton, Canada
  • Research SiteCambridge, Canada
  • Research SiteConcord, Canada
  • Research SiteGuelph, Canada
  • Research SiteToronto, Canada
  • Research SiteBenešov, Czechia
  • Research SiteBrandýs nad Labem, Czechia
  • Research SiteBrno, Czechia
  • Research SiteLouny, Czechia
  • Research SiteNáchod, Czechia

And 30 more, listed on the interactive page.

Sources for sites
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  • 2023
  • 2023-506197-12-00
Sources for references
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Related records

Drugs (1)

Lead sponsors (1)