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

Study identifier:D7960C00006

ClinicalTrials.gov identifier:NCT06173570

EudraCT identifier:N/A

CTIS identifier:2023-506197-12-00

Recruiting

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

Medical condition

Dyslipidemia

Phase

Phase 2

Healthy volunteers

Study drug

AZD0780, Placebo

Sex

All

Estimated Enrollment

375

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 19 Jan 2024

Estimated Primary Completion Date: 13 Nov 2024

Estimated Study Completion Date: 27 Nov 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2024 by AstraZeneca

Collaborators

AstraZeneca K.K.

Inclusion and exclusion 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.

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Arms	Assigned Interventions
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

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]