[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07013643":3,"trial-entities:NCT07013643":154,"trial-summary:NCT07013643":158},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":55,"secondary_outcomes":68,"sex":101,"minimum_age":102,"maximum_age":103,"healthy_volunteers":104,"eligibility_criteria":105,"std_ages":125,"locations":128,"central_contacts":145,"overall_officials":151,"references":152,"see_also_links":153},"NCT07013643","D8750C00006","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","RECRUITING","2027-07-09","2026-08","2026-08-18","2025-06-04","AstraZeneca","INDUSTRY",false,"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.","This is a Phase I, open-label, single-sequence, multiple-cohort study which will be performed at multiple study sites in healthy females of childbearing and non-childbearing potential.\n\nThe purpose of this study is to investigate the effect of AZD6234, AZD9550 and a combination of AZD9550 and AZD6234 on the PK, safety and tolerability of a CoC, ethinyl estradiol\u002Flevonorgestrel (EE\u002FLEVO).\n\nThe study will have 4 cohorts, and each cohort will consist of 5 periods which include, Screening, Start, Up-titration, Maintenance, and Follow-up periods.",[19],"Healthy Participants",[21,22,23,24,25],"Obesity","Overweight","Oral contraceptives","Pharmacokinetics","Drug Interaction","INTERVENTIONAL","TREATMENT",[29],"PHASE1",{"count":31,"type":32},50,"ESTIMATED",[34,42,47,51],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","AZD6234","AZD6234 will be administered as a subcutaneous injection in the abdomen.",[39,40,41],"Cohort-1: AZD6234 + EE\u002FLEVO + Acetaminophen (APAP)","Cohort-2: AZD6234+AZD9550+EE\u002FLEVO+APAP","Cohort-4: AZD6234+AZD9550+EE\u002FLEVO+APAP",{"type":35,"name":43,"description":44,"armGroupLabels":45},"Ethinyl estradiol\u002FLevonorgestrel (EE\u002FLEVO)","EE\u002FLEVO will be administered as combined oral tablets.",[39,40,46,41],"Cohort-3: AZD9550 + EE\u002FLEVO + APAP",{"type":35,"name":48,"description":49,"armGroupLabels":50},"Acetaminophen (APAP)","APAP will be administered orally as a solution.",[39,40,46,41],{"type":35,"name":52,"description":53,"armGroupLabels":54},"AZD9550","AZD9550 will be administered as a subcutaneous injection in the abdomen.",[40,46,41],[56,60,62,64,66],{"measure":57,"description":58,"timeFrame":59},"Area under the concentration-time curve from time 0 to infinity (AUCinf) of EE and LEVO","To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE\u002FLEVO.","Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253",{"measure":61,"description":58,"timeFrame":59},"Area under the concentration-time curve from time of dosing to the last measurable concentration (AUClast) of EE and LEVO",{"measure":63,"description":58,"timeFrame":59},"Maximum plasma concentration (Cmax) of EE and LEVO",{"measure":65,"description":58,"timeFrame":59},"Time to reach maximum drug concentration in plasma (tmax) of EE and LEVO",{"measure":67,"description":58,"timeFrame":59},"Elimination half-life (t1\u002F2λz) of EE and LEVO",[69,73,77,81,83,85,89,91,93,97,99],{"measure":70,"description":71,"timeFrame":72},"Number of participants with adverse events (AEs)","To assess the safety and tolerability of AZD6234, co-administered AZD9550 and AZD6234, and AZD9550 with CoC EE\u002FLEVO.","Cohort 1: Up to Day 120; Cohort 2: Up to Day 216; Cohort 3: Up to Day 272; Cohort 4: Up to Day 300",{"measure":74,"description":75,"timeFrame":76},"Number of participants developing detectable anti-drug antibodies (ADAs) against AZD6234 and AZD9550","To assess the immunogenicity of AZD6234, co-administered AZD9550 and AZD6234, and AZD9550 with CoC EE\u002FLEVO.","Cohort 1: At predefined intervals from Day -2 up to Day 120; Cohort 2: At predefined intervals from Day -2 up to Day 216; Cohort 3: At predefined intervals from Day -2 up to Day 272; ; Cohort 4: At predefined intervals from Day -2 up to Day 300",{"measure":78,"description":79,"timeFrame":80},"Area under plasma concentration-time curve from time 0 to 168 hours postdose (AUC0-168h) of AZD6234","To characterize the PK of single and multiple doses of AZD6234.","Cohort 1: At predefined intervals from Day 1 to Day 120",{"measure":82,"description":79,"timeFrame":80},"AUClast of AZD6234",{"measure":84,"description":79,"timeFrame":80},"Cmax of AZD6234",{"measure":86,"description":87,"timeFrame":88},"AUC0-168h of co-administered AZD6234 and AZD9550","To characterize the PK of single and multiple doses of co-administered AZD6234 and AZD9550.","Cohort 2: At predefined intervals from Day 8 to Day 216; Cohort 4: At predefined intervals from Day 78 to Day 300",{"measure":90,"description":87,"timeFrame":88},"AUClast of co-administered AZD6234 and AZD9550",{"measure":92,"description":87,"timeFrame":88},"Cmax of co-administered AZD6234 and AZD9550",{"measure":94,"description":95,"timeFrame":96},"AUC0-168h of AZD9550","To characterize the PK of single and multiple doses of AZD9550.","Cohort 3: At predefined intervals from Day 8 up to Day 272",{"measure":98,"description":95,"timeFrame":96},"AUClast of AZD9550",{"measure":100,"description":95,"timeFrame":96},"Cmax of AZD9550","FEMALE","35 Years","75 Years",true,{"inclusion":106,"exclusion":111,"raw_text":124},[107,108,109,110],"All participants must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.","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.","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.",[112,113,114,115,116,117,118,119,120,121,122,123],"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).","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\u002Fsurgical procedure, or trauma.","Any laboratory values with deviations or clinically important abnormalities in clinical chemistry, hematology, or urinalysis.","Any positive result on screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) or Human immunodeficiency virus (HIV).","Abnormal vital signs.","Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead electrocardiogram (ECG), at screening.","Current smokers or those who have smoked or used nicotine products.","Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.","History of severe allergy\u002Fhypersensitivity or ongoing clinically important allergy\u002Fhypersensitivity.","Statin treatment within 4 weeks prior to the start of study treatment.","Current use of estrogen-containing products.","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.",[126,127],"ADULT","OLDER_ADULT",[129,138],{"facility":130,"status":8,"city":131,"state":132,"zip":133,"country":134,"geoPoint":135},"Research Site","Glendale","California","91206","United States",{"lat":136,"lon":137},34.14251,-118.25508,{"facility":130,"status":8,"city":139,"state":140,"zip":141,"country":134,"geoPoint":142},"Brooklyn","Maryland","21225",{"lat":143,"lon":144},39.23039,-76.60219,[146],{"name":147,"role":148,"phone":149,"email":150},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[],[],[],{"nct_id":4,"conditions":155,"biomarkers":157},[156,21,22],"Healthy Volunteers",[],{"nct_id":4,"found":104,"summary":159,"prompt_version":169},{"design":160,"status":161,"heading":162,"summary":163,"follow_up":164,"word_count":165,"commitments":166,"compensation":167,"drugs_mentioned":168},"This is an open-label (meaning you and the study staff will know what treatments you are receiving) study with multiple groups of participants. It will involve 50 healthy female participants.","completed","Study on AZD6234 and AZD9550 with Oral Contraceptives in Healthy Women","This study is looking at how two medications, AZD6234 and AZD9550, either alone or together, affect how your body processes a common birth control pill (Ethinyl Estradiol\u002FLevonorgestrel). We are looking for healthy women, aged 35 to 75, who are living with overweight or obesity to participate. The main goal is to see how the levels of the birth control hormones change in your blood when you also take AZD6234, AZD9550, or both. This helps us understand if these medications interact with birth control. The study is currently unclear on its recruitment status and plans to enroll 50 participants.","Your blood levels of the birth control hormones will be measured for up to 253 days after starting the study.",98,"You will receive AZD6234 and\u002For AZD9550 as injections, and Ethinyl Estradiol\u002FLevonorgestrel as oral tablets. Blood samples will be taken at specific times over periods ranging from 99 to 253 days.","Not stated in the trial record.",[36,52],"v2"]