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NCT07013643Active, not recruitingPhase 1

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

An Open-label, Single-sequence Multiple Cohort Study to Assess the Effect of Multiple Doses of AZD6234, AZD9550, 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

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
100 (actual)
First submitted
2 Jun 2025
Start date
4 Jun 2025
Primary completion date
9 Jul 2027
Lead sponsor
AstraZeneca
Diseases
Obesity
NCT number
NCT07013643

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 100
  • From 4 Jun 2025 to the primary completion date, 9 Jul 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • 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.
  • 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.

Lab values

  • 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).
  • 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).

Other

  • 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.
  • Current use of estrogen-containing products.

Who the study is looking for

  • 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.

Age in the registry: 35 years to 75 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
BrooklynUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
GlendaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.