Phase
Condition
Dyslipidemia
Treatment
Placebo
AZD4954
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
All Parts:
Participants with plasminogen level (concentration) within normal range at theScreening Visit.
All females must have a negative pregnancy test at the Screening Visit and onadmission to the study site.
Females of childbearing potential must not be lactating and if heterosexually activemust 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 potentialmust adhere to the study specific contraception methods from the time of firstadministration of study intervention until 3 months after the study Follow-up Visit.
Parts A and B (Healthy Participants):
Male and female participants aged 18 to 65 years with suitable veins for cannulationor 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 whoare ethnically Japanese. This includes second and third generation Japanesewhose parents or grandparents are living in a country other than Japan.
A Chinese participant is defined as having both parents and 4 grandparents whoare ethnically Chinese. This includes second and third generation Chinese whoseparents or grandparents are living in a country other than China.Part B (Healthy Participants):
- 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 cannulationor 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 ≥ 2months prior to the Screening Visit, according to the American College ofCardiology/American Heart Association guidelines on blood cholesterol management.
Participants with documented coronary artery disease, stroke, or peripheral arterydisease or at moderate or high risk for an atherosclerotic cardiovascular diseaseevent.
There should be no planned medication or dose change during study participation.
Exclusion
Exclusion Criteria:
All Parts:
History of any clinically important disease or disorder.
History or presence of gastrointestinal, hepatic, or renal disease or any othercondition known to interfere with absorption, distribution, metabolism, or excretionof drugs.
Any clinically important illness, medical/surgical procedure, or trauma within 4weeks 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) orhave a prothrombin time/international normalized ratio (PT/INR) or activated partialthromboplastin time (aPTT) > 1.25 times × upper limit normal (ULN).
Any clinically important abnormalities in hematology, coagulation, clinicalchemistry, 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 immunodeficiencyvirus (HIV).
Any clinically important abnormalities in rhythm, conduction, or morphology of theresting 12-lead electrocardiogram (ECG) at Screening.
Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeksprior 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 × dailyrecommended levels of vitamins and minerals during the 2 weeks prior to the firstadministration of study intervention or longer if the medication has a longhalf-life.
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.
Study Design
Study Description
Connect with a study center
Research Site
Glendale, California 91206
United StatesSite Not Available
Research Site
Glendale 5352423, California 5332921 91206
United StatesActive - Recruiting
Research Site
Jacksonville, Florida 32216
United StatesSite Not Available
Research Site
Inverness 4159786, Florida 4155751 34452
United StatesSite Not Available
Research Site
Jacksonville 4160021, Florida 4155751 32216
United StatesSite Not Available
Research Site
Brooklyn, Maryland 21225
United StatesSite Not Available
Research Site
Brooklyn 4349594, Maryland 4361885 21225
United StatesActive - Recruiting
Research Site
San Antonio, Texas 78229
United StatesSite Not Available
Research Site
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.