NCT07013643

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
8mo left

Started Jun 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

June 2, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

June 2, 2025

Last Update Submit

April 9, 2026

Conditions

Healthy Participants

Keywords

ObesityOverweightOral contraceptivesPharmacokineticsDrug Interaction

Outcome Measures

Primary Outcomes (5)

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

    To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.

    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 272

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

    To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.

    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 272

  • Maximum plasma concentration (Cmax) of EE and LEVO

    To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.

    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 272

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

    To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.

    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 272

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

    To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.

    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 272

Secondary Outcomes (11)

  • Number of participants with adverse events (AEs)

    Cohort 1: Up to Day 120; Cohort 2: Up to Day 216; Cohort 3: Up to Day 272

  • Number of participants developing detectable anti-drug antibodies (ADAs) against AZD6234 and AZD9550

    Cohort 1: At predefined intervals from Day -2 up to Day 120; Cohort 2: At predefined intervals from Day -2 up to Day 216; Cohort 3: At predefined intervals from Day -2 up to Day 272

  • Area under plasma concentration-time curve from time 0 to 168 hours postdose (AUC0-168h) of AZD6234

    Cohort 1: At predefined intervals from Day 1 to Day 120

  • AUClast of AZD6234

    Cohort 1: At predefined intervals from Day 1 to Day 120

  • Cmax of AZD6234

    Cohort 1: At predefined intervals from Day 1 to Day 120

  • +6 more secondary outcomes

Study Arms (3)

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

EXPERIMENTAL

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.

Drug: AZD6234Drug: Ethinyl estradiol/Levonorgestrel (EE/LEVO)Drug: Acetaminophen (APAP)

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

EXPERIMENTAL

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

Drug: AZD6234Drug: Ethinyl estradiol/Levonorgestrel (EE/LEVO)Drug: Acetaminophen (APAP)Drug: AZD9550

Cohort-3 AZD9550 + EE/LEVO + APAP

EXPERIMENTAL

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.

Drug: Ethinyl estradiol/Levonorgestrel (EE/LEVO)Drug: Acetaminophen (APAP)Drug: AZD9550

Interventions

AZD6234DRUG

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

Cohort-1 AZD6234 + EE/LEVO + Acetaminophen (APAP)Cohort-2: AZD6234+AZD9550+EE/LEVO+APAP
Ethinyl estradiol/Levonorgestrel (EE/LEVO)DRUG

EE/LEVO will be administered as combined oral tablets.

Cohort-1 AZD6234 + EE/LEVO + Acetaminophen (APAP)Cohort-2: AZD6234+AZD9550+EE/LEVO+APAPCohort-3 AZD9550 + EE/LEVO + APAP
Acetaminophen (APAP)DRUG

APAP will be administered orally as a solution.

Cohort-1 AZD6234 + EE/LEVO + Acetaminophen (APAP)Cohort-2: AZD6234+AZD9550+EE/LEVO+APAPCohort-3 AZD9550 + EE/LEVO + APAP
AZD9550DRUG

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

Cohort-2: AZD6234+AZD9550+EE/LEVO+APAPCohort-3 AZD9550 + EE/LEVO + APAP

Eligibility Criteria

Age35 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Glendale, California, 91206, United States

RECRUITING

Research Site

Brooklyn, Maryland, 21225, United States

RECRUITING

MeSH Terms

Conditions

ObesityOverweight

Interventions

Ethinyl EstradiolLevonorgestrelAcetaminophen

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNorgestrelNorpregnenesAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2025

First Posted

June 10, 2025

Study Start

June 4, 2025

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

December 25, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

US(2)