A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With Dyslipidemia

Part of paid clinical trials in Glendale, California.

Sponsor
AstraZeneca
Study ID
NCT06980428
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD4954 — DRUG
    AZD4954 will be administered orally.
  • Placebo — DRUG
    Placebo will be administered orally.

Study Details

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4954 in healthy participants with or without elevated Lipoprotein(a) (Lp\[a\]) levels and participants with dyslipidemia.

Key Dates

Start date
May 27, 2025
Status verified
Jun 2026
Primary completion
Dec 4, 2026
Completion
Dec 4, 2026

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A1: SAD Cohort 1 - AZD4954 (Dose 1)
    Participants will receive a single dose of AZD4954 (Dose 1) or matching placebo on Day 1.
  • Experimental: Part A1: SAD Cohort 2 - AZD4954 (Dose 2)
    Participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1.
  • Experimental: Part A1: SAD Cohort 3 - AZD4954 (Dose 3)
    Participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1.
  • Experimental: Part A1: SAD Cohort 4 - AZD4954 (Dose 4)
    Participants will receive a single dose of AZD4954 (Dose 4) or matching placebo on Day 1.
  • Experimental: Part A1: SAD Cohort 5 - AZD4954 (Dose 5)
    Participants will receive a single dose of AZD4954 (Dose 5) or matching placebo on Day 1.
  • Experimental: Part A1: SAD Optional Cohort 6 - AZD4954 (Dose 6)
    Participants will receive a single dose of AZD4954 (Dose 6) or matching placebo on Day 1. This additional cohort may be added depending on the findings.
  • Experimental: Part A1: SAD Cohort 1 (Japanese) - AZD4954 (Dose 2)
    Japanese participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1.
  • Experimental: Part A1: SAD Cohort 2 (Japanese) - AZD4954 (Dose 3)
    Japanese participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1.
  • Experimental: Part A1: SAD Optional Cohort 3 (Japanese) - AZD4954
    This additional cohort may be added depending on the findings.
  • Experimental: Part A1: SAD Cohort 1 (Chinese) - AZD4954 (Dose 5)
    Chinese participants will receive a single dose of AZD4954 (Dose 5) or matching placebo at the highest dose level on Day 1.
  • Experimental: Part A2: SAD Food Effect Cohort - AZD4954 (Dose 2)
    Participants will receive a single dose of AZD4954 (Dose 2) or matching placebo with a high-calorie, high-fat breakfast on Day 1.
  • Experimental: Part A2: SAD Food Effect Cohort - AZD4954 (Dose 3)
    Participants will receive a single dose of AZD4954 (Dose 3) or matching placebo with a high-calorie, high-fat breakfast on Day 1.
  • Experimental: Part B: Global MAD Cohort 1 (healthy participants) - AZD4954 (Dose 1)
    Participants will receive multiple doses of AZD4954 (Dose 1) or matching placebo for 21 days.
  • Experimental: Part B: Global MAD Cohort 2 (healthy participants) - AZD4954 (Dose 2)
    Participants will receive multiple doses of AZD4954 (Dose 2) or matching placebo for 21 days.
  • Experimental: Part B: Global MAD Cohort 3 (healthy participants) - AZD4954 (Dose 3)
    Participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 21 days.
  • Experimental: Part B: Optional Global MAD Cohort 4 (healthy participants) - AZD4954
    Participants will receive multiple doses of AZD4954 or matching placebo for 21 days. This additional cohort may be added depending on the findings.
  • Experimental: Part B: MAD Cohort (Japanese) - AZD4954 (Dose 3)
    Japanese participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 21 days.
  • Experimental: Part B: Global MAD Cohort (participants with dyslipidemia) - AZD4954 (Dose 1)
    Participants with dyslipidemia will receive multiple doses of AZD4954 (Dose 1) or matching placebo for 21 days.

Primary Outcome Measure

Part A: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 29±2 days) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteGlendaleCalifornia91206-
Research SiteInvernessFlorida34452-
Research SiteJacksonvilleFlorida32216-
Research SitePort OrangeFlorida32127-
Research SiteBrooklynMaryland21225-
Research SiteSan AntonioTexas78229-

Find similar trials in Glendale, CA

By research site
Research Site· Glendale, CAResearch Site· Inverness, FLResearch Site· Jacksonville, FLResearch Site· Port Orange, FLResearch Site· Brooklyn, MDResearch Site· San Antonio, TX

Related Studies