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

NCT07423598 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: D7960C00021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Keywords

Pharmacokinetics; Pharmacodynamics; Repeated dosing; Dyslipidemia; Elevated low-density lipoprotein cholesterol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Area under concentration-time curve from time 0 to infinity (AUCinf)

  At pre-defined intervals from Day 1 to Day 40

• Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

  At pre-defined intervals from Day 1 to Day 40

• Maximum observed drug concentration (Cmax)

  At pre-defined intervals from Day 1 to Day 40

• Number of participants with adverse events (AEs) and serious adverse events (SAEs)

  Upto Day 40

Study Arms (2)

AZD0780

EXPERIMENTAL

Participants will receive a dose of AZD0780.

Drug: AZD0780

Placebo

PLACEBO COMPARATOR

Participants will receive a dose of matching placebo to AZD0780

Drug: Placebo

Interventions

AZD0780 DRUG

AZD0780 will be administered orally.

AZD0780

Placebo DRUG

Placebo will be administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Brooklyn, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

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

Locations

US (1)