A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics With AZD0780 Following Repeated Dose Administration in Healthy Adults With Elevated LDL-C Levels

A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 Following Repeated Dose Administration to Healthy Adults With Elevated LDL-C Levels

The purpose of this study is to evaluate pharmacodynamics (PD) of AZD0780 compared with placebo by assessment of low-density lipoprotein-cholesterol (LDL-C) levels following repeated oral dosing in healthy adults with elevated LDL-C levels.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Placebo; Drug: AZD0780

Detailed Description

This is a Phase I, randomized, single-blind, placebo-controlled study of AZD0780 in healthy adults with elevated LDL-C levels.

The study comprises of:

• An optional Pre-screening visit.
• A Screening Period (maximum 28 days).
• Admission to the Clinical Unit (Day -1).
• A Treatment Period for administration of AZD0780 or placebo (Days 1 to 28).
• Follow-up Visit 12 ± 2 days after the last study intervention dose.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Brooklyn, Maryland, United States, 21225
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy participants with suitable veins for cannulation or repeated venipuncture.
• All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
• Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
• Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
• Have a body mass index between 18 and 35 kg/m2 inclusive and weigh at least 50 kg.
• Fasting LDL-C ≥ 70 mg/dL and < 190 mg/dL at Screening.

Exclusion Criteria:

• History of any clinically important disease or disorder.
• History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration.
• Any abnormal vital signs or laboratory values including clinical chemistry, hematology, coagulation, or urinalysis results.
• Current smokers or those who have smoked or used nicotine products (including e-cigarettes) or any known or suspected history of alcohol or drug abuse.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, especially to drugs with a similar chemical structure or class to AZD0780.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AZD0780; Participants will receive a dose of AZD0780.	Drug: AZD0780; AZD0780 will be administered orally.
Placebo Comparator: Placebo; Participants will receive a dose of matching placebo to AZD0780	Drug: Placebo; Placebo will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change from baseline in LDL-C levels	To determine the pharmacodynamic profile of AZD0780 versus placebo by evaluating LDL-C concentrations after repeated oral administration	From Baseline (Day 1) to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under concentration-time curve from time 0 to infinity (AUCinf)	To characterize the single dose and steady state pharmacokinetics (PK) of AZD0780 following oral administration of AZD0780	At pre-defined intervals from Day 1 to Day 40
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)	To characterize the single dose and steady state PK of AZD0780 following oral administration of AZD0780	At pre-defined intervals from Day 1 to Day 40
Maximum observed drug concentration (Cmax)	To characterize the single dose and steady state PK of AZD0780 following oral administration of AZD0780	At pre-defined intervals from Day 1 to Day 40
Number of participants with adverse events (AEs) and serious adverse events (SAEs)	To assess the safety and tolerability of AZD0780 versus placebo following oral administration of repeated dosing in healthy participants	Upto Day 40

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Dyslipidemia; Pharmacokinetics; Pharmacodynamics; Repeated dosing; Elevated low-density lipoprotein cholesterol
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Dyslipidemias
• Other Study ID Numbers: D7960C00021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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 shared.

• IPD Sharing 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.
• IPD Sharing 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. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No