NCT07513571

Brief Summary

The purpose this study is to measure the impact of laroprovstat (AZD0780) on the pharmacokinetics (PK) of AZD4954 and the impact of AZD4954 on the PK of laroprovstat in healthy male and female participants.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
2mo left

Started Apr 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

March 31, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

March 31, 2026

Last Update Submit

April 17, 2026

Conditions

Healthy Participants

Keywords

PharmacokineticsDrug-drug interactionDyslipidemiasHypercholesterolemiaLipoprotein (a)

Outcome Measures

Primary Outcomes (4)

  • Area under concentration time curve from time 0 to infinity (AUCinf) of AZD4954

    To assess the effect of a single dose of oral laroprovstat on the PK of a single dose of oral AZD4954 in healthy participants.

    Cohort 1: Day 1 to Day 41

  • Maximum observed drug concentration (Cmax) of AZD4954

    To assess the effect of a single dose of oral laroprovstat on the PK of a single dose of oral AZD4954 in healthy participants.

    Cohort 1: Day 1 to Day 41

  • AUCinf of laroprovstat

    To assess the effect of a single dose of oral AZD4954 on the PK of a single dose of oral laroprovstat in healthy participants.

    Cohort 2: Day 1 to Day 25

  • Cmax of laroprovstat

    To assess the effect of a single dose of oral AZD4954 on the PK of a single dose of oral laroprovstat in healthy participants.

    Cohort 2: Day 1 to Day 25

Secondary Outcomes (15)

  • Area under concentration curve from time 0 to the last quantifiable concentration (AUClast) of AZD4954

    Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31

  • Apparent total body clearance (CL/F) of AZD4954

    Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31

  • Terminal elimination half-life (t½λz) of AZD4954

    Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31

  • Time to reach maximum observed concentration (tmax) of AZD4954

    Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31

  • Time of last quantifiable concentration (tlast) of AZD4954

    Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31

  • +10 more secondary outcomes

Study Arms (2)

Cohort 1: Treatment Sequence AC

EXPERIMENTAL

Participant will receive single dose of AZD4954 alone (Treatment A) followed by single doses of laroprovstat+AZD4954 (Treatment C).

Drug: AZD4954Drug: Laroprovstat

Cohort 2: Treatment Sequence BC

EXPERIMENTAL

Participant will receive single dose of laroprovstat alone (Treatment B) followed by single doses of laroprovstat+AZD4954 (Treatment C).

Drug: AZD4954Drug: Laroprovstat

Interventions

AZD4954DRUG

AZD4954 will be administered orally.

Cohort 1: Treatment Sequence ACCohort 2: Treatment Sequence BC
LaroprovstatDRUG

Laroprovstat will be administered orally.

Also known as: AZD0780
Cohort 1: Treatment Sequence ACCohort 2: Treatment Sequence BC

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All females must have a negative pregnancy test at the Screening Visit.
  • 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.
  • Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
  • Have a body mass index between 18 and 35 kg/m2 inclusive and weigh at least 50 kg.

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 of study intervention.
  • Participants with known bleeding or coagulation disorders.
  • Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs.
  • Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  • Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram at screening.
  • Participants who are current smokers or have used any tobacco or nicotine-containing products (including e-cigarettes) within 3 months prior to screening; known or suspected history of alcohol or drug abuse; positive screen for drugs of abuse, alcohol, or cotinine at screening or on each admission to the Clinical Unit.
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs of a similar chemical structure or class to AZD4954 or laroprovstat.
  • Participants who have previously received AZD4954.
  • Treatment with any lipid-lowering therapy or laroprovstat within the 3 months prior to the Screening Visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Glendale, California, 91206, United States

RECRUITING

MeSH Terms

Conditions

DyslipidemiasHypercholesterolemia

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperlipidemias

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 7, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

July 9, 2026

Study Completion (Estimated)

July 9, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

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 rerefer 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
More information

Locations

US(1)