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

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ClinicalTrials.gov Identifier: NCT06173570
Recruitment Status : Recruiting
First Posted : December 15, 2023
Last Update Posted : April 12, 2024
Sponsor:
Collaborator:
AstraZeneca K.K.
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: AZD0780 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized with equal distribution across 5 parallel treatment arms to either placebo or one of four AZD0780 doses.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 19, 2024
Estimated Primary Completion Date : November 13, 2024
Estimated Study Completion Date : November 27, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A
AZD0780, Dose 1
 Drug: AZD0780
AZD0780 administered orally, once daily for 12 weeks
Experimental: Arm B
AZD0780, Dose 2
 Drug: AZD0780
AZD0780 administered orally, once daily for 12 weeks
Experimental: Arm C
AZD0780, Dose 3
 Drug: AZD0780
AZD0780 administered orally, once daily for 12 weeks
Experimental: Arm D
AZD0780, Dose 4
 Drug: AZD0780
AZD0780 administered orally, once daily for 12 weeks
Placebo Comparator: Arm E
Placebo, matched for appearance
 Drug: Placebo
Placebo administered orally, once daily for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  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 ]
    Blood samples will be collected and LDL-C level for baseline up to week 12 assessed to evaluate the effect of different doses of AZD0780 compared to placebo, in 'ideal' scenarios in which intercurrent events would not occur.


Secondary Outcome Measures :
  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 ]
    Blood samples will be collected and LDL-C level for baseline up to week 12 assessed to evaluate the effect of different doses of AZD0780 compared to placebo, in 'real-world' conditions.

  2. AZD0780 Plasma Concentrations Summarized by Sampling Timepoint [ Time Frame: From week 1 up to week 12 ]
    Blood samples will be collected and the concentration of AZD0780 in plasma at specific timepoints used to assess the pharmacokinetics of AZD0780.

  3. Percent Change from Baseline at Week 12 in Other Lipid Parameters and Inflammatory Markers [ Time Frame: From first day of treatment up to week 12 ]
    Blood samples drawn at specific timepoints throughout the study will be assessed to evaluate the effects of different doses of AZD0780 compared to placebo from baseline at week 12, in 'ideal' scenarios in which intercurrent events do not occur, in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides, Non-High-Density Lipoprotein Cholesterol (non-HDL-C), Very Low-Density Lipoprotein Cholesterol (VLDL-C), Apolipoprotein A-1 (ApoA1), Apolipoprotein B-100 (ApoB), Lipoprotein (a) (Lp(a)), Remnant Cholesterol, and High-Sensitivity C-Reactive Protein (hsCRP).

  4. Percent Change from Baseline at Week 12 in Other Lipid Parameters and Inflammatory Markers [ Time Frame: From first day of treatment up to week 12 ]
    Blood samples drawn at specific timepoints throughout the study will be assessed to evaluate the effects of different doses of AZD0780 compared to placebo from baseline at week 12, in 'real-world' conditions, in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides, Non-High-Density Lipoprotein Cholesterol (non-HDL-C), Very Low-Density Lipoprotein Cholesterol (VLDL-C), Apolipoprotein A-1 (ApoA1), Apolipoprotein B-100 (ApoB), Lipoprotein (a) (Lp(a)), Remnant Cholesterol, and High-Sensitivity C-Reactive Protein (hsCRP).


Other Outcome Measures:
  1. Number of Participants with Adverse Events [ Time Frame: From first day of treatment up to week 14 ]
    Assessment of safety and tolerability of AZD0780 compared to placebo.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06173570


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
AstraZeneca K.K.
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT06173570    
Other Study ID Numbers: D7960C00006
First Posted: December 15, 2023    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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 refer 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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Dyslipidemia,
Low-Density Lipoprotein Cholesterol
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases