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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

Description

This study will measure the effects of multiple doses of AZD6234 and a combination of AZD6234 and AZD9550 given as injection(s) on pharmacokinetics (PK) of combined oral contraceptive ethinyl estradiol (EE)/levonorgestrel (LEVO) in healthy female participants with obesity.

Study Overview

Study Details

Study overview

This study will measure the effects of multiple doses of AZD6234 and a combination of AZD6234 and AZD9550 given as injection(s) on pharmacokinetics (PK) of combined oral contraceptive ethinyl estradiol (EE)/levonorgestrel (LEVO) in healthy female participants with obesity.

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

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

Condition
Healthy Participants
Intervention / Treatment

-

Contacts and Locations

Glendale

Research Site, Glendale, California, United States, 91206

Brooklyn

Research Site, Brooklyn, Maryland, United States, 21225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * 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.

Ages Eligible for Study

35 Years to 75 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2026-01-07