RecruitingPhase 1

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

United States50 participantsStarted 2025-06-04

Plain-language summary

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)/levonorgestrel (LEVO) in healthy female participants with obesity.

Who can participate

Age range

35 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. 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. * 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 Criteria: * 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 hist…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

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

Maximum plasma concentration (Cmax) of EE and LEVO

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

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

Trial details

NCT IDNCT07013643

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-09

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

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