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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age35-75
SponsorAstraZeneca

About this trial

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

Qualifiers

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) 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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

50 Participants
are divided into 4 treatment groups

Sponsors and collaborators