Recruiting
Phase 1

AZD6234, AZD9550

Sponsor:

AstraZeneca

Code:

NCT07013643

Conditions

Healthy Participants

Eligibility Criteria

Sex: Female

Age: 35 - 70+

Healthy Volunteers: Accepted

Interventions

AZD6234

Ethinyl estradiol/Levonorgestrel (EE/LEVO)

Acetaminophen (APAP)

AZD9550

Study Details

Brief 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.

Conditions

Healthy Participants

Study ID

NCT07013643

Start date

Jun 4, 2025

Status verified date

Aug, 2026

Completion date

Jul 9, 2027

Anticipated

Primary completion date

Jul 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 70+

Healthy Volunteers: Accepted

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 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort-1: AZD6234 + EE/LEVO + Acetaminophen (APAP)

All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 administration.

experimental: Cohort-2: AZD6234+AZD9550+EE/LEVO+APAP

All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 (up to a maximum dose of Dose X1) and AZD9550 (up to a maximum dose of Dose Y1) administration.

experimental: Cohort-3: AZD9550 + EE/LEVO + APAP

All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD9550 administration.

experimental: Cohort-4: AZD6234+AZD9550+EE/LEVO+APAP

All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 (up to a maximum dose of Dose X2) and AZD9550 (up to a maximum dose of Dose Y1) administration.

Interventions

AZD6234

AZD6234 will be administered as a subcutaneous injection in the abdomen.

Ethinyl estradiol/Levonorgestrel (EE/LEVO)

EE/LEVO will be administered as combined oral tablets.

Acetaminophen (APAP)

APAP will be administered orally as a solution.

AZD9550

AZD9550 will be administered as a subcutaneous injection in the abdomen.

Primary outcome measure

  • Area under the concentration-time curve from time 0 to infinity (AUCinf) of EE and LEVO [ Time Frame: 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 [ Time Frame: 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 ]
  • Maximum plasma concentration (Cmax) of EE and LEVO [ Time Frame: 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 ]
  • Time to reach maximum drug concentration in plasma (tmax) of EE and LEVO [ Time Frame: 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 ]
  • Elimination half-life (t1/2λz) of EE and LEVO [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Glendale, California, United States, 91206

Research Site

Recruiting

Brooklyn, Maryland, United States, 21225

More Information

Sponsor

AstraZeneca

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Obesity
  • Overweight
  • Oral contraceptives
  • Pharmacokinetics
  • Drug Interaction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-18.