[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053223":3},{"organization":4,"armGroups":7,"interventions":83,"overallOfficials":89,"centralContacts":94,"locations":100,"responsibleParty":158,"collaborators":89,"id":160,"slug":161,"hasResults":162,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":89,"eligibilityCriteria":166,"healthyVolunteers":162,"sex":167,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":89,"studyType":173,"phases":174,"briefSummary":176,"conditions":177,"keywords":180,"overallStatus":103,"whyStopped":89,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,15,19,23,27,31,35,39,43,47,51,55,59,63,67,71,75,79],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A1: SAD Cohort 1 - AZD4954 (Dose 1)","EXPERIMENTAL","Participants will receive a single dose of AZD4954 (Dose 1) or matching placebo on Day 1.",[13,14],"Drug: AZD4954","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Part A1: SAD Cohort 2 - AZD4954 (Dose 2)","Participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Part A1: SAD Cohort 3 - AZD4954 (Dose 3)","Participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Part A1: SAD Cohort 4 - AZD4954 (Dose 4)","Participants will receive a single dose of AZD4954 (Dose 4) or matching placebo on Day 1.",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Part A1: SAD Cohort 5 - AZD4954 (Dose 5)","Participants will receive a single dose of AZD4954 (Dose 5) or matching placebo on Day 1.",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Part A1: SAD Optional Cohort 6 - AZD4954 (Dose 6)","Participants will receive a single dose of AZD4954 (Dose 6) or matching placebo on Day 1. This additional cohort may be added depending on the findings.",[13,14],{"label":36,"type":10,"description":37,"interventionNames":38},"Part A1: SAD Cohort 1 (Japanese) - AZD4954 (Dose 2)","Japanese participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1.",[13,14],{"label":40,"type":10,"description":41,"interventionNames":42},"Part A1: SAD Cohort 2 (Japanese) - AZD4954 (Dose 3)","Japanese participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1.",[13,14],{"label":44,"type":10,"description":45,"interventionNames":46},"Part A1: SAD Optional Cohort 3 (Japanese) - AZD4954","This additional cohort may be added depending on the findings.",[13,14],{"label":48,"type":10,"description":49,"interventionNames":50},"Part A1: SAD Cohort 1 (Chinese) - AZD4954 (Dose 5)","Chinese participants will receive a single dose of AZD4954 (Dose 5) or matching placebo at the highest dose level on Day 1.",[13,14],{"label":52,"type":10,"description":53,"interventionNames":54},"Part A2: SAD Food Effect Cohort - AZD4954 (Dose 2)","Participants will receive a single dose of AZD4954 (Dose 2) or matching placebo with a high-calorie, high-fat breakfast on Day 1.",[13,14],{"label":56,"type":10,"description":57,"interventionNames":58},"Part A2: SAD Food Effect Cohort - AZD4954 (Dose 3)","Participants will receive a single dose of AZD4954 (Dose 3) or matching placebo with a high-calorie, high-fat breakfast on Day 1.",[13,14],{"label":60,"type":10,"description":61,"interventionNames":62},"Part B: Global MAD Cohort 1 (healthy participants) - AZD4954 (Dose 1)","Participants will receive multiple doses of AZD4954 (Dose 1) or matching placebo for 21 days.",[13,14],{"label":64,"type":10,"description":65,"interventionNames":66},"Part B: Global MAD Cohort 2 (healthy participants) - AZD4954 (Dose 2)","Participants will receive multiple doses of AZD4954 (Dose 2) or matching placebo for 21 days.",[13,14],{"label":68,"type":10,"description":69,"interventionNames":70},"Part B: Global MAD Cohort 3 (healthy participants) - AZD4954 (Dose 3)","Participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 21 days.",[13,14],{"label":72,"type":10,"description":73,"interventionNames":74},"Part B: Optional Global MAD Cohort 4 (healthy participants) - AZD4954","Participants will receive multiple doses of AZD4954 or matching placebo for 21 days. This additional cohort may be added depending on the findings.",[13,14],{"label":76,"type":10,"description":77,"interventionNames":78},"Part B: MAD Cohort (Japanese) - AZD4954 (Dose 3)","Japanese participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 21 days.",[13,14],{"label":80,"type":10,"description":81,"interventionNames":82},"Part B: Global MAD Cohort (participants with dyslipidemia) - AZD4954 (Dose 1)","Participants with dyslipidemia will receive multiple doses of AZD4954 (Dose 1) or matching placebo for 21 days.",[13,14],[84,90],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":89},"DRUG","AZD4954","AZD4954 will be administered orally.",[48,36,9,40,16,20,24,28,44,32,52,56,80,60,64,68,76,72],null,{"type":85,"name":91,"description":92,"armGroupLabels":93,"otherNames":89},"Placebo","Placebo will be administered orally.",[48,36,9,40,16,20,24,28,44,32,52,56,80,60,64,68,76,72],[95],{"name":96,"role":97,"phone":98,"phoneExt":89,"email":99},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[101,115,124,132,140,149],{"facility":102,"status":103,"city":104,"state":105,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":89},"Research Site","RECRUITING","Glendale","California","91206","United States","US",{"type":110,"coordinates":111},"Point",[112,113],-118.25508,34.14251,{"lat":113,"lon":112},{"facility":102,"status":103,"city":116,"state":117,"zip":118,"country":107,"countryCode":108,"cosmosGeoPoint":119,"geoPoint":123,"contacts":89},"Inverness","Florida","34452",{"type":110,"coordinates":120},[121,122],-82.33037,28.83582,{"lat":122,"lon":121},{"facility":102,"status":103,"city":125,"state":117,"zip":126,"country":107,"countryCode":108,"cosmosGeoPoint":127,"geoPoint":131,"contacts":89},"Jacksonville","32216",{"type":110,"coordinates":128},[129,130],-81.65565,30.33218,{"lat":130,"lon":129},{"facility":102,"status":103,"city":133,"state":117,"zip":134,"country":107,"countryCode":108,"cosmosGeoPoint":135,"geoPoint":139,"contacts":89},"Port Orange","32127",{"type":110,"coordinates":136},[137,138],-80.99561,29.13832,{"lat":138,"lon":137},{"facility":102,"status":103,"city":141,"state":142,"zip":143,"country":107,"countryCode":108,"cosmosGeoPoint":144,"geoPoint":148,"contacts":89},"Brooklyn","Maryland","21225",{"type":110,"coordinates":145},[146,147],-76.60219,39.23039,{"lat":147,"lon":146},{"facility":102,"status":103,"city":150,"state":151,"zip":152,"country":107,"countryCode":108,"cosmosGeoPoint":153,"geoPoint":157,"contacts":89},"San Antonio","Texas","78229",{"type":110,"coordinates":154},[155,156],-98.49363,29.42412,{"lat":156,"lon":155},{"type":159,"investigatorFullName":89,"investigatorTitle":89,"investigatorAffiliation":89,"oldNameTitle":89,"oldOrganization":89},"SPONSOR","100053223","phase-1-a-study-to-investigate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-azd4954-in-healthy-adult-participants-with-or-without-elevated-lipoprotein-a-lpa-levels-and-participants-with-dyslipidemia-100053223",false,"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","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","Inclusion Criteria:\n\nAll Parts:\n\n* Participants with plasminogen level (concentration) within normal range at the Screening Visit.\n* All females must have a negative pregnancy test at the Screening Visit and on admission to the study site.\n* Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.\n* Females of non-childbearing potential must be confirmed at the Screening Visit.\n* 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.\n\nParts A and B (Healthy Participants):\n\n* Male and female participants aged 18 to 65 years with suitable veins for cannulation or repeated venipuncture.\n* Have a body mass index (BMI) between 18 and 35 kg\u002Fm² inclusive.\n* For Japanese and Chinese participants (Parts A and B):\n\n  1. 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 than Japan.\n  2. 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 China.\n\n     Part B (Healthy Participants):\n* Participants must have elevated Lp(a) ≥ 30 mg\u002FdL at the Screening Visit.\n\nPart B (Participants with Dyslipidemia):\n\n* Male and female participants aged 18 to 70 years with suitable veins for cannulation or repeated venipuncture.\n* Have a BMI \\> 18 kg\u002Fm².\n* Participants must have elevated Lp(a) ≥ 70 mg\u002FdL at the Screening Visit.\n* Participants with a fasting LDL-C ≥ 70 mg\u002FdL and \\\u003C 190 mg\u002FL at the Screening Visit.\n* 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\u002FAmerican Heart Association guidelines on blood cholesterol management.\n* Participants with documented coronary artery disease, stroke, or peripheral artery disease or at moderate or high risk for an atherosclerotic cardiovascular disease event.\n* There should be no planned medication or dose change during study participation.\n\nExclusion Criteria:\n\nAll Parts:\n\n* History of any clinically important disease or disorder.\n* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* Any clinically important illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the first administration of study intervention.\n* Participants with known bleeding or coagulation disorders.\n* Participants who have an elevated high-sensitivity C-reactive protein (\\> 3 mg\u002FL) or have a prothrombin time\u002Finternational normalized ratio (PT\u002FINR) or activated partial thromboplastin time (aPTT) \\> 1.25 times × upper limit normal (ULN).\n* Any clinically important abnormalities in hematology, coagulation, clinical chemistry, urinalysis, abnormal vital signs or abnormal laboratory values.\n* 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).\n* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG) at Screening.\n* Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of study intervention.\n\nParts A and B (Healthy Participants):\n\n* Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol\u002Facetaminophen), 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.\n* Current smokers or those who have smoked or used nicotine products.\n\nPart B (Participants with Dyslipidemia):\n\n* Acute ischemic cardiovascular event in the last 12 months prior to randomization.\n* Poorly controlled diabetes.\n* Previous administration of Lp(a) inhibitor.\n* Have uncontrolled hypertension.\n* Abnormal vital heart rate.","ALL","18 Years","70 Years",{"count":171,"type":172},136,"ESTIMATED","INTERVENTIONAL",[175],"PHASE1","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.",[178,179],"Healthy Participants","Dyslipidemia",[181,182],"Lipoprotein(a)","Low-density lipoprotein cholesterol (LDL-C)","2026-07-10",{"date":185,"type":186},"2026-07-13","ACTUAL",{"date":188,"type":186},"2025-05-27",{"date":190,"type":172},"2026-12-04",{"name":5,"class":6},6]