A Study of AZD4954 for Healthy Adults and Those with Dyslipidemia
This study is testing a new medication called AZD4954. Researchers want to see how safe it is, how well your body handles it (tolerability), and how it moves through and affects your body (pharmacokinetics and pharmacodynamics). The study includes healthy adults, some with high levels of Lipoprotein(a) (Lp[a]), and others with dyslipidemia (unhealthy levels of fats in the blood). Participants will receive either AZD4954 or a placebo (an inactive substance) by mouth. The main goal is to track any side effects or serious problems that might happen. About 136 people aged 18 to 70 years old are expected to join. The study status is currently unclear.
- Study design
- This is a placebo-controlled study with single and multiple ascending doses of AZD4954. It plans to enroll about 136 participants.
- What's involved
- You would have a screening period, be admitted to a study site, and receive the study drug or placebo for either 1 day or 21 days. There will be follow-up visits after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in Part A will have a follow-up visit about 29 days after their dose. Participants in Part B will have a follow-up visit about 49 days after their last dose.
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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
Recruiting
PHASE1Ages 18–70InterventionalTreatmentAstraZeneca
~136 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:AZD4954Placebo
At a glance
Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured over From Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 29±2 days)
+1 more outcome measured
Conditions
Where it's being run
6 sites across 4 statesFlorida3
California1
Maryland1
Texas1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants with plasminogen level (concentration) within normal range at the Screening Visit.
All females must have a negative pregnancy test at the Screening Visit and on admission to the study site.
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 at the Screening Visit.
Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods from the time of first administration of study intervention until 3 months after the study Follow-up Visit.
Male and female participants aged 18 to 65 years with suitable veins for cannulation or repeated venipuncture.
Have a body mass index (BMI) between 18 and 35 kg/m² inclusive.
For Japanese and Chinese participants (Parts A and B):
Participants must have elevated Lp(a) ≥ 30 mg/dL at the Screening Visit.
Male and female participants aged 18 to 70 years with suitable veins for cannulation or repeated venipuncture.
Have a BMI \> 18 kg/m².
Participants must have elevated Lp(a) ≥ 70 mg/dL at the Screening Visit.
Participants with a fasting LDL-C ≥ 70 mg/dL and \< 190 mg/L at the Screening Visit.
Participants should be receiving moderate or high-intensity statin therapy for ≥ 2 months prior to the Screening Visit, according to the American College of Cardiology/American Heart Association guidelines on blood cholesterol management.
Participants with documented coronary artery disease, stroke, or peripheral artery disease or at moderate or high risk for an atherosclerotic cardiovascular disease event.
There should be no planned medication or dose change during study participation.
Exclusion
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.
Participants who have an elevated high-sensitivity C-reactive protein (\> 3 mg/L) or have a prothrombin time/international normalized ratio (PT/INR) or activated partial thromboplastin time (aPTT) \> 1.25 times × upper limit normal (ULN).
Any clinically important abnormalities in hematology, coagulation, clinical chemistry, urinalysis, abnormal vital signs or abnormal laboratory values.
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 (ECG) at Screening.
Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of study intervention.
Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, intake of \> 3 × daily recommended levels of vitamins and minerals during the 2 weeks prior to the first administration of study intervention or longer if the medication has a long half-life.
Current smokers or those who have smoked or used nicotine products.
Acute ischemic cardiovascular event in the last 12 months prior to randomization.
Poorly controlled diabetes.
Previous administration of Lp(a) inhibitor.
Have uncontrolled hypertension.
Abnormal vital heart rate.
What this trial measures
- Part A: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)From Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 29±2 days)
To assess the safety and tolerability of AZD4954 following oral administration of SAD (Part A).
- Part B: Number of participants with AEs and SAEsFrom Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 49±2 days)
To assess the safety and tolerability of AZD4954 following oral administration of MAD (Part B).