How AZD6234 and AZD9550 affect combined oral contraceptive hormones in women 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/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity
This trial will test whether injections of AZD6234, AZD9550, or both change how a combined oral contraceptive (ethinyl estradiol/levonorgestrel) is processed in healthy women with overweight or obesity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 35 Years to 75 Years |
| Sex | Female |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 2 sites (Glendale, California and 1 other locations) |
| Trial ID | NCT07013643 on ClinicalTrials.gov |
What this trial studies
This is a Phase I, open-label, single-sequence, multiple-cohort pharmacokinetic study conducted at multiple clinical sites in healthy female participants with overweight or obesity. The study enrolls three cohorts and follows five periods per cohort: screening, start, up-titration, maintenance, and follow-up. Participants will receive injections of AZD6234, AZD9550, or a combination alongside dosing with a combined oral contraceptive (EE/levonorgestrel) and will undergo blood sampling to measure hormone pharmacokinetics as well as safety and tolerability monitoring. Concomitant use of acetaminophen and other protocol-specified procedures may be included per cohort to support safety and PK analyses.
Who should consider this trial
Good fit: Healthy adult women with a BMI of 25–40 kg/m2 who are not using hormonal or estrogen-containing contraception and who meet childbearing or non-childbearing potential criteria are the intended participants.
Not a fit: Women with significant medical conditions such as diabetes, cardiovascular or thromboembolic disease, those outside the BMI range, or those already using hormonal/estrogen-containing birth control are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, the results could clarify whether these injected therapies change contraceptive hormone levels, helping clinicians and patients make safer contraceptive choices during treatment.
How similar studies have performed: Drug–drug interaction studies with other agents have shown that some treatments can change contraceptive hormone levels, but the specific effects of AZD6234 and AZD9550 on EE/levonorgestrel are novel and have not been clinically characterized.
Eligibility criteria
Show full inclusion / exclusion criteria
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. 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 and cohort 2), type I or type II diabetes mellitus, glycated hemoglobin (HbA1c) ≥ 6.5% at screening, history of neoplastic disease, basal calcitonin level \>50 ng/L (50 pg/L) at screening (cohort 2 and cohort 3), history of acute or chronic pancreatitis or pancreatic amylase or lipase \>2×ULN at screening (cohort 2 and cohort 3), 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 and cohort 3). * 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.
Where this trial is running
Glendale, California and 1 other locations
- Research Site — Glendale, California, United States (Recruiting)
- Research Site — Brooklyn, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.