Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-06-03
136
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD4954 in healthy adults, both with and without elevated Lipoprotein(a) (Lp[a]) levels, as well as in participants with dyslipidemia. This early-phase, placebo-controlled study includes healthy male and female participants and those with dyslipidemia, focusing on how the body processes AZD4954 and its effects on Lp(a) and cholesterol levels. The study has two parts: Part A involves single ascending doses (SAD) of AZD4954 or placebo, with participants receiving one dose on Day 1 followed by monitoring. Part B involves multiple ascending doses (MAD) where participants receive AZD4954 or placebo once daily for 21 days, with different cohorts including healthy participants globally, Japanese participants, and those with dyslipidemia. Various cohorts may receive different dose levels or food-effect assessments. Participants undergo a screening period up to 28 days before dosing, admission to the study site, treatment periods (single dose for Part A; 21 days of daily dosing for Part B), and follow-up visits 26 to 30 days after the last dose. Researchers monitor adverse events, drug levels in the body, changes in Lp(a), and cholesterol measures. Safety, tolerability, and how the drug moves through and affects the body are carefully evaluated throughout the study.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have plasminogen levels within the normal range at screening.
- Female participants must have negative pregnancy tests at screening and upon admission.
- Females able to have children must not be breastfeeding and must agree to use effective contraception if sexually active.
- Females not able to have children must be confirmed as such at screening.
- Sexually active fertile males must use study-specific contraception from first dose until 3 months after follow-up.
- For Parts A and B (Healthy Participants): aged 18 to 65 years, male or female, with suitable veins for blood sampling.
- Body mass index (BMI) between 18 and 35 kg/m² for healthy participants.
- Japanese participants must have both parents and four grandparents who are ethnically Japanese; Chinese participants must have both parents and four grandparents who are ethnically Chinese.
- Part B healthy participants must have elevated Lipoprotein(a) levels of 30 mg/dL or higher at screening.
- For Part B participants with dyslipidemia: aged 18 to 70 years, male or female, with suitable veins for blood sampling.
- BMI above 18 kg/m² for participants with dyslipidemia.
- Dyslipidemia participants must have elevated Lipoprotein(a) levels of 70 mg/dL or higher.
- Dyslipidemia participants must have fasting LDL cholesterol between 70 and less than 190 mg/dL.
- Dyslipidemia participants should have been on moderate or high-intensity statin therapy for at least 2 months before screening.
- Participants with dyslipidemia should have documented coronary artery disease, stroke, peripheral artery disease, or moderate to high risk of cardiovascular events.
- No planned medication or dose changes during the study participation.
You will not qualify if you...
- History of any important disease or disorder.
- History or presence of gastrointestinal, liver, or kidney disease or other conditions affecting drug absorption or metabolism.
- Any significant illness, medical procedure, or trauma within 4 weeks before the first dose.
- Known bleeding or clotting disorders.
- Elevated high-sensitivity C-reactive protein above 3 mg/L or abnormal blood clotting test results.
- Clinically important abnormalities in blood tests, vital signs, or lab values.
- Positive screening for hepatitis B, hepatitis C, or HIV infections.
- Abnormal heart rhythm or ECG results at screening.
- Use of enzyme-inducing drugs like St John's Wort within 3 weeks before first dose.
- For healthy participants: use of prescribed or nonprescribed medications (except paracetamol), herbal remedies, or high vitamin/mineral intake within 2 weeks before first dose.
- Current smokers or recent users of nicotine products.
- For participants with dyslipidemia: acute ischemic cardiovascular event within last 12 months.
- Poorly controlled diabetes.
- Previous use of Lipoprotein(a) inhibitors.
- Uncontrolled high blood pressure.
- Abnormal heart rate or vital signs.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person)
Duration - 1 to 21 days depending on cohort
Participants receive either a single dose or multiple doses of AZD4954 or placebo at the study site, depending on cohort assignment.
1 to 22 visits including admission and dosing visits depending on cohort
Duration - Approximately 1 month
Participants have follow-up visits to assess safety and drug effects after treatment ends.
1 visit (in-person) within 26 to 30 days after last dose
Trial Site Locations
Total: 6 locations
1
Research Site
Glendale, California, United States, 91206
Actively Recruiting
2
Research Site
Inverness, Florida, United States, 34452
Actively Recruiting
3
Research Site
Jacksonville, Florida, United States, 32216
Actively Recruiting
4
Research Site
Port Orange, Florida, United States, 32127
Not Yet Recruiting
5
Research Site
Brooklyn, Maryland, United States, 21225
Actively Recruiting
6
Research Site
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
18
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