A study to investigate the effect of AZD6234 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

Study identifier:D8750C00006

ClinicalTrials.gov identifier:NCT07013643

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

An open-label, single-sequence multiple cohort study to assess the effect of multiple doses of AZD6234 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

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD6234, Ethinyl estradiol/Levonorgestrel (EE/LEVO), Acetaminophen (APAP), AZD9550

Sex

Female

Estimated Enrollment

Study type

Interventional

Age

35 Years - 75 Years

Date

Study Start Date: 04 Jun 2025

Estimated Primary Completion Date: 07 Jan 2026

Estimated Study Completion Date: 07 Jan 2026

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2025 by AstraZeneca

Collaborators

Inclusion and 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 combined oral contraceptive assessment.
• Females of non-childbearing potential must be confirmed at the Screening Visit.
• Have a Body Mass Index (BMI) ≥ 25 kg/m2 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, 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), history of acute or chronic pancreatitis or pancreatic amylase or lipase >2×ULN at screening (cohort 2), 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)).
• 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.

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Arms	Assigned Interventions
Experimental: Cohort-1 AZD6234 + EE/LEVO + Acetaminophen (APAP) Participants will receive combined oral contraceptive (EE/LEVO) and, separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 administration.	Drug: AZD6234 AZD6234 will be administered as a subcutaneous injection in the abdomen. Drug: Ethinyl estradiol/Levonorgestrel (EE/LEVO) EE/LEVO will be administered as combined oral tablets. Drug: Acetaminophen (APAP) APAP will be administered orally as a solution.
Experimental: Cohort-2: AZD6234+AZD9550+EE/LEVO+APAP All participants will receive combined oral contraceptive EE/LEVO and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous administered AZD6234 and AZD9550.	Drug: AZD6234 AZD6234 will be administered as a subcutaneous injection in the abdomen. Drug: Ethinyl estradiol/Levonorgestrel (EE/LEVO) EE/LEVO will be administered as combined oral tablets. Drug: Acetaminophen (APAP) APAP will be administered orally as a solution. Drug: AZD9550 AZD9550 will be administered as a subcutaneous injection in the abdomen.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]