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Tests treatment safety and results for Healthy Participants
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
ClinicalTrials.gov ID: NCT06980428
What this study is testing
What is AZD4954?
AZD4954 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for healthy participants.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- All Parts:
- 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...
- Females of non-childbearing potential must be confirmed at the Screening Visit.
You likely can't join if
- All Parts:
- 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...
- 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)...
See the full eligibility criteria
- All Parts:
- 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...
- 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):
- A Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese. This includes second and third generation Japanese whose parents or grandparents are living in a country other...
- A Chinese participant is defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than...
- Participants must have elevated Lp(a) ≥ 30 mg/dL at the Screening Visit. Part B (Participants with Dyslipidemia):
- 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...
- 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.
- All Parts:
- 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...
- 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. Parts A and B (Healthy Participants):
- 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...
- Current smokers or those who have smoked or used nicotine products. Part B (Participants with Dyslipidemia):
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
- Inverness, Florida, United States
- Jacksonville, Florida, United States
- Port Orange, Florida, United States
- Brooklyn, Maryland, United States
- San Antonio, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, California, United States; Inverness, Florida, United States; Jacksonville, Florida, United States; Port Orange, Florida, United States; Brooklyn, Maryland, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.