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

Dyslipidemia Clinical Trial

— PURSUIT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173570
• Other study ID #: D7960C00006
• Status: Recruiting
• Phase: Phase 2
• Start date: January 19, 2024
• Est. completion date: November 27, 2024

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: November 27, 2024
• Est. primary completion date: November 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• AZD0780
AZD0780 administered orally, once daily for 12 weeks
• Placebo
Placebo administered orally, once daily for 12 weeks

Locations

Country	Name	City	State
Canada	Research Site	Barrie	Ontario
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Cambridge	Ontario
Canada	Research Site	Concord	Ontario
Canada	Research Site	Guelph	Ontario
Canada	Research Site	Sarnia	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Czechia	Research Site	Benesov
Czechia	Research Site	Brandys nad Labem
Czechia	Research Site	Brno
Czechia	Research Site	Louny
Czechia	Research Site	Nachod
Czechia	Research Site	Praha
Czechia	Research Site	Pribram
Czechia	Research Site	Teplice
Czechia	Research Site	Uherske Hradiste
Denmark	Research Site	Aarhus
Denmark	Research Site	Herning
Denmark	Research Site	Hvidovre
Denmark	Research Site	Svendborg
Denmark	Research Site	Viborg
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Orosháza
Hungary	Research Site	Pécs
Japan	Research Site	Chuo-ku
Japan	Research Site	Itabashi-ku
Japan	Research Site	Kasuya-gun
Japan	Research Site	Tama-shi
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Brezno
Slovakia	Research Site	Lucenec
Slovakia	Research Site	Presov
Slovakia	Research Site	Roznava
Slovakia	Research Site	Svidnik
Slovakia	Research Site	Trebisov
Spain	Research Site	Barcelona
Spain	Research Site	Cordoba
Spain	Research Site	Ferrol
Spain	Research Site	La Coruna
Spain	Research Site	Santiago de Compostela
Spain	Research Site	Sevilla
Spain	Research Site	Sevilla
Spain	Research Site	Sevilla
United States	Research Site	Boca Raton	Florida
United States	Research Site	Chicago	Illinois
United States	Research Site	Columbus	Ohio
United States	Research Site	Fargo	North Dakota
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Gurnee	Illinois
United States	Research Site	Hialeah	Florida
United States	Research Site	Huntsville	Alabama
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Inverness	Florida
United States	Research Site	Jacksonville	Florida
United States	Research Site	Lincoln	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	New Windsor	New York
United States	Research Site	Palm Springs	California
United States	Research Site	San Marcos	Texas
United States	Research Site	Santa Ana	California

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	AstraZeneca K.K.

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Denmark,  Hungary,  Japan,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Adverse Events	Assessment of safety and tolerability of AZD0780 compared to placebo.	From first day of treatment up to week 14
Primary	Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Level from Baseline 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.	From first day of treatment up to week 12
Secondary	Percent Change from Baseline of Low-Density Lipoprotein Cholesterol (LDL-C) at 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.	From first day of treatment up to week 12
Secondary	AZD0780 Plasma Concentrations Summarized by Sampling Timepoint	Blood samples will be collected and the concentration of AZD0780 in plasma at specific timepoints used to assess the pharmacokinetics of AZD0780.	From week 1 up to week 12
Secondary	Percent Change from Baseline at Week 12 in Other Lipid Parameters and Inflammatory Markers	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).	From first day of treatment up to week 12
Secondary	Percent Change from Baseline at Week 12 in Other Lipid Parameters and Inflammatory Markers	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).	From first day of treatment up to week 12