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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Dyslipidemia

Treatments: Drug: Placebo; Drug: AZD0780

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06173570

2023-506197-12-00 (Registry Identifier)

D7960C00006

Details and patient eligibility

About

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.

Enrollment: 428 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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428 participants in 5 patient groups, including a placebo group

Arm A

Experimental group

Description:

AZD0780, Dose 1

Treatment:

Drug: AZD0780

Arm B

Experimental group

Description:

AZD0780, Dose 2

Treatment:

Drug: AZD0780

Arm C

Experimental group

Description:

AZD0780, Dose 3

Treatment:

Drug: AZD0780

Arm D

Experimental group

Description:

AZD0780, Dose 4

Treatment:

Drug: AZD0780

Arm E

Placebo Comparator group

Description:

Placebo, matched for appearance

Treatment:

Drug: Placebo