[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593992":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":48,"locations":54,"responsibleParty":78,"collaborators":35,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":35,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":35,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":57,"whyStopped":35,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,16,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort-1: AZD6234 + EE\u002FLEVO + Acetaminophen (APAP)","EXPERIMENTAL","All participants will receive CoC (EE\u002FLEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 administration.",[13,14,15],"Drug: AZD6234","Drug: Ethinyl estradiol\u002FLevonorgestrel (EE\u002FLEVO)","Drug: Acetaminophen (APAP)",{"label":17,"type":10,"description":18,"interventionNames":19},"Cohort-2: AZD6234+AZD9550+EE\u002FLEVO+APAP","All participants will receive CoC (EE\u002FLEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 (up to a maximum dose of Dose X1) and AZD9550 (up to a maximum dose of Dose Y1) administration.",[13,14,15,20],"Drug: AZD9550",{"label":22,"type":10,"description":23,"interventionNames":24},"Cohort-3: AZD9550 + EE\u002FLEVO + APAP","All participants will receive CoC (EE\u002FLEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD9550 administration.",[14,15,20],{"label":26,"type":10,"description":27,"interventionNames":28},"Cohort-4: AZD6234+AZD9550+EE\u002FLEVO+APAP","All participants will receive CoC (EE\u002FLEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 (up to a maximum dose of Dose X2) and AZD9550 (up to a maximum dose of Dose Y1) administration.",[13,14,15,20],[30,36,40,44],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","AZD6234","AZD6234 will be administered as a subcutaneous injection in the abdomen.",[9,17,26],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Ethinyl estradiol\u002FLevonorgestrel (EE\u002FLEVO)","EE\u002FLEVO will be administered as combined oral tablets.",[9,17,22,26],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Acetaminophen (APAP)","APAP will be administered orally as a solution.",[9,17,22,26],{"type":31,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"AZD9550","AZD9550 will be administered as a subcutaneous injection in the abdomen.",[17,22,26],[49],{"name":50,"role":51,"phone":52,"phoneExt":35,"email":53},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[55,69],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":35},"Research Site","RECRUITING","Glendale","California","91206","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-118.25508,34.14251,{"lat":67,"lon":66},{"facility":56,"status":57,"city":70,"state":71,"zip":72,"country":61,"countryCode":62,"cosmosGeoPoint":73,"geoPoint":77,"contacts":35},"Brooklyn","Maryland","21225",{"type":64,"coordinates":74},[75,76],-76.60219,39.23039,{"lat":76,"lon":75},{"type":79,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100593992","phase-1-a-study-to-investigate-the-effect-of-azd6234-azd9550-and-a-combination-of-azd9550-and-azd6234-on-pharmacokinetics-of-combined-oral-contraceptive-ethinyl-estradiollevonorgestrel-in-healthy-female-participants-living-with-overweight-or-obesity-100593992",false,"NCT07013643","A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol\u002FLevonorgestrel in Healthy Female Participants Living With Overweight or Obesity","An Open-label, Single-sequence Multiple Cohort Study to Assess the Effect of Multiple Doses of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on the Pharmacokinetics of Single Doses of Combined Oral Contraceptive Ethinyl Estradiol\u002FLevonorgestrel in Healthy Female Participants Living With Overweight or Obesity","Inclusion Criteria:\n\n* All participants must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.\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\n  o Hormonal contraceptives and estrogen-containing hormonal methods of birth control are not permitted due to potential effect and influence on the results using a CoC assessment.\n* Females of non-childbearing potential must be confirmed at the Screening Visit.\n* Have a Body Mass Index (BMI) between 25 and 40 kg\u002Fm2, both inclusive and weigh at least 60 kg for Cohorts 1, 2, and 3 and a BMI of \\> 30 kg\u002Fm2 for Cohort 4.\n\nExclusion Criteria:\n\n* History of any clinically important disease or disorder (gastroparesis, deep vein thrombosis, venous thromboembolism, previous surgery of the upper gastrointestinal tract, cardiovascular disease, neuromuscular or neurogenic disease, severe vitamin D deficiency (cohort 1, cohort 2 and cohort 4), type I or type II diabetes mellitus, glycated hemoglobin (HbA1c) ≥ 6.5% at screening, history of neoplastic disease (cohort 2, cohort 3 and cohort 4), basal calcitonin level \\>50 ng\u002FL (50 pg\u002FL) at screening (cohort 2, cohort 3 and cohort 4), history of acute or chronic pancreatitis or pancreatic amylase or lipase \\>2×ULN at screening (cohort 2, cohort 3 and cohort 4), prior history of cholecystectomy or untreated cholelithiasis and personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (MEN2) (cohort 2, cohort 3 and cohort 4).\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.\n* Any laboratory values with deviations or clinically important abnormalities in clinical chemistry, hematology, or urinalysis.\n* Any positive result on screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) or Human immunodeficiency virus (HIV).\n* Abnormal vital signs.\n* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead electrocardiogram (ECG), at screening.\n* Current smokers or those who have smoked or used nicotine products.\n* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.\n* History of severe allergy\u002Fhypersensitivity or ongoing clinically important allergy\u002Fhypersensitivity.\n* Statin treatment within 4 weeks prior to the start of study treatment.\n* Current use of estrogen-containing products.",true,"FEMALE","35 Years","75 Years",{"count":92,"type":93},50,"ESTIMATED","INTERVENTIONAL",[96],"PHASE1","This study will measure the effects of multiple doses of AZD6234, AZD9550 and a combination of AZD9550 and AZD6234 given as injection(s) on pharmacokinetics (PK) of combined oral contraceptive (CoC) ethinyl estradiol (EE)\u002Flevonorgestrel (LEVO) in healthy female participants with obesity.",[99],"Healthy Participants",[101,102,103,104,105],"Obesity","Overweight","Oral contraceptives","Pharmacokinetics","Drug Interaction","2026-06-12",{"date":108,"type":109},"2026-06-15","ACTUAL",{"date":111,"type":109},"2025-06-04",{"date":113,"type":93},"2027-07-09",{"name":5,"class":6},2]