NCT06980428

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

A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4954 Following Single and Multiple Ascending Dose Administration to Healthy Participants With or Without Elevated Lp(a) Levels, and Participants With Dyslipidemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a first time in human, placebo-controlled, single and multiple ascending dose (SAD and MAD) study in healthy male and female participants (Part A) or healthy participants with elevated Lp(a) levels (≥ 30 mg/dL) and participants with dyslipidemia with elevated Lp(a) levels (≥ 70 mg/dL) and low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL and \< 190 mg/dL (Part B). The study consists of 2 parts: Part A (SAD) and Part B (MAD). Part A of the study will consist of Part A1 and Part A2, comprising: * A Screening Period of maximum 28 days. * Admission to study site (Day -1). * A Treatment Period (Day 1 to Day 15 at the study site) with a single dose of AZD4954 or placebo on Day 1. * A Follow-up Visit within 26 to 30 days after the study intervention dose for all cohorts (Day 29 ±2 days). Part B has 3 types of MAD cohorts - global cohorts with healthy participants, global cohort with participants with dyslipidemia, and a Japanese cohort. The global MAD cohorts (healthy participants) and Japanese MAD cohort will comprise: * A Screening Period of maximum 28 days. * Admission to study site (Day -1). * A Treatment Period during which participants will receive either AZD4954 or placebo once daily for 21 days (Day 1 to 21). * A Follow-up Visit within 26 to 30 days after the last study intervention dose (Day 49 ±2 days). The global MAD cohort (participants with dyslipidemia) will comprise: * A Screening Period of maximum 28 days. * Residential study site visits from Day -1 to Day 2 and Day 21 to Day 22. * Non-residential study site visits on Day 8 and Day 15. * A Treatment Period during which participants will receive either AZD4954 or placebo once daily for 21 days (Day 1 to 21). * A Follow-up Visit within 26 to 30 days after the last study intervention dose (Day 49 ± 2 days).

Conditions

• Healthy Participants
• Dyslipidemia

Interventions

Type	Name	Description
DRUG	AZD4954	AZD4954 will be administered orally.
DRUG	Placebo	Placebo will be administered orally.

Timeline

• Start date: 2025-05-27
• Primary completion: 2026-12-04
• Completion: 2026-12-04
• First posted: 2025-05-20
• Last updated: 2026-03-27

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study