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

Last updated: May 8, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1

Condition

Obesity

Hypertriglyceridemia

Diabetes Prevention

Treatment

AZD6234

Ethinyl estradiol/Levonorgestrel (EE/LEVO)

Acetaminophen (APAP)

Clinical Study ID

NCT07013643
D8750C00006
  • Ages 35-75
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All participants must have a negative pregnancy test at the Screening Visit and onadmission to the Clinical Unit.

  • Females of childbearing potential must not be lactating and if heterosexuallyactive, must agree to use an approved method of highly effective contraception. o Hormonal contraceptives and estrogen-containing hormonal methods of birth controlare not permitted due to potential effect and influence on the results using a CoCassessment.

  • 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 atleast 60 kg.

Exclusion

Exclusion Criteria:

  • History of any clinically important disease or disorder (gastroparesis, deep veinthrombosis, venous thromboembolism, previous surgery of the upper gastrointestinaltract, cardiovascular disease, neuromuscular or neurogenic disease, severe vitamin Ddeficiency (cohort 1 and cohort 2), type I or type II diabetes mellitus, glycatedhemoglobin (HbA1c) ≥ 6.5% at screening, history of neoplastic disease, basalcalcitonin level >50 ng/L (50 pg/L) at screening (cohort 2 and cohort 3), history ofacute or chronic pancreatitis or pancreatic amylase or lipase >2×ULN at screening (cohort 2 and cohort 3), prior history of cholecystectomy or untreatedcholelithiasis and personal or family history of medullary thyroid cancer (MTC) ormultiple endocrine neoplasia type 2 (MEN2) (cohort 2 and cohort 3).

  • History or presence of gastrointestinal, hepatic, or renal disease or any othercondition known to interfere with absorption, distribution, metabolism, or excretionof drugs.

  • Any clinically important illness, medical/surgical procedure, or trauma.

  • Any laboratory values with deviations or clinically important abnormalities inclinical 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 theresting 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 importantallergy/hypersensitivity.

  • Statin treatment within 4 weeks prior to the start of study treatment.

  • Current use of estrogen-containing products.

Study Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: AZD6234
Phase: 1
Study Start date:
June 04, 2025
Estimated Completion Date:
December 25, 2026

Study Description

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.

The 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/levonorgestrel (EE/LEVO).

The study will have 3 cohorts, and each cohort will consist of 5 periods which include, Screening, Start, Up-titration, Maintenance, and Follow-up periods.

Connect with a study center

  • Research Site

    Glendale, California 91206
    United States

    Active - Recruiting

  • Research Site

    Glendale 5352423, California 5332921 91206
    United States

    Site Not Available

  • Research Site

    Brooklyn, Maryland 21225
    United States

    Active - Recruiting

  • Research Site

    Brooklyn 4349594, Maryland 4361885 21225
    United States

    Site Not Available

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