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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/Levonorgestrel). 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.

Study design
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.
What's involved
You will receive AZD6234 and/or AZD9550 as injections, and Ethinyl Estradiol/Levonorgestrel as oral tablets. Blood samples will be taken at specific times over periods ranging from 99 to 253 days.
Compensation
Not stated in the trial record.
Follow-up
Your blood levels of the birth control hormones will be measured for up to 253 days after starting the study.

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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/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity

Recruiting
PHASE1Ages 35–75InterventionalTreatment
AstraZeneca
~50 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:AZD6234Ethinyl estradiol/Levonorgestrel (EE/LEVO)Acetaminophen (APAP)AZD9550

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area under the concentration-time curve from time 0 to infinity (AUCinf) of EE and LEVO
Measured over 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
+4 more outcomes measured

Conditions

Healthy Participants

Explore related trials

Healthy VolunteersObesityOverweight

Where it's being run

2 sites across 2 states
California1
Maryland1

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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/m2, both inclusive and weigh at least 60 kg for Cohorts 1, 2, and 3 and a BMI of \> 30 kg/m2 for Cohort 4.

Exclusion

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/L (50 pg/L) 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/surgical 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/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
Statin treatment within 4 weeks prior to the start of study treatment.
Current use of estrogen-containing products.

What this trial measures

  • Area under the concentration-time curve from time 0 to infinity (AUCinf) of EE and LEVOCohort 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

    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/LEVO.

  • Area under the concentration-time curve from time of dosing to the last measurable concentration (AUClast) of EE and LEVOCohort 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

    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/LEVO.

  • Maximum plasma concentration (Cmax) of EE and LEVOCohort 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

    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/LEVO.

  • Time to reach maximum drug concentration in plasma (tmax) of EE and LEVOCohort 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

    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/LEVO.

  • Elimination half-life (t1/2λz) of EE and LEVOCohort 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

    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/LEVO.