Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-05-01
136
Participants Needed
6
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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.
- Females must have a negative pregnancy test at screening and admission.
- Females of childbearing potential must not be lactating and must agree to use highly effective contraception if sexually active.
- Females of non-childbearing potential must be confirmed at screening.
- Sexually active fertile males must use contraception from first dose until 3 months after follow-up.
- For Parts A and B (healthy participants): aged 18 to 65 years 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 ethnically Japanese.
- Chinese participants must have both parents and four grandparents ethnically Chinese.
- Part B healthy participants must have elevated Lp(a) levels of 30 mg/dL or higher.
- Part B participants with dyslipidemia: aged 18 to 70 years with suitable veins.
- Dyslipidemia participants must have BMI over 18 kg/m².
- Dyslipidemia participants must have elevated Lp(a) levels of 70 mg/dL or higher.
- Dyslipidemia participants must have fasting LDL-C between 70 and 190 mg/dL.
- Receiving moderate or high-intensity statin therapy for at least 2 months before screening.
- Documented coronary artery disease, stroke, peripheral artery disease, or moderate/high risk for atherosclerotic cardiovascular disease.
- No planned medication or dose changes during study participation.
You will not qualify if you...
- History of any clinically important disease or disorder.
- History or presence of gastrointestinal, liver, kidney disease, or conditions affecting drug metabolism.
- Illness, surgery, or trauma within 4 weeks before first dose.
- Known bleeding or clotting disorders.
- Elevated C-reactive protein (>3 mg/L) or prolonged blood clotting times (PT/INR or aPTT >1.25× upper limit).
- Abnormal blood tests, vital signs, or laboratory values.
- Positive tests for hepatitis B, hepatitis C, or HIV.
- Abnormal resting electrocardiogram.
- Use of enzyme-inducing drugs like St John's Wort within 3 weeks before first dose.
- For healthy participants: use of prescription or nonprescription medications (except paracetamol), herbal remedies, or high-dose vitamins within 2 weeks before dosing.
- Current smokers or recent users of nicotine products.
- For dyslipidemia participants: acute ischemic cardiovascular event in last 12 months.
- Poorly controlled diabetes.
- Previous use of Lp(a) inhibitors.
- Uncontrolled high blood pressure.
- Abnormal heart rate.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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