Phase
Condition
Obesity
Hypertriglyceridemia
Diabetes Prevention
Treatment
AZD6234
Ethinyl estradiol/Levonorgestrel (EE/LEVO)
Acetaminophen (APAP)
Clinical Study ID
Ages 35-75 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
All participants must have a negative pregnancy test at the Screening Visit and onadmission to the Clinical Unit.
Females of childbearing potential must not be lactating and if heterosexuallyactive, must agree to use an approved method of highly effective contraception. o Hormonal contraceptives and estrogen-containing hormonal methods of birth controlare not permitted due to potential effect and influence on the results using a CoCassessment.
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 atleast 60 kg.
Exclusion
Exclusion Criteria:
History of any clinically important disease or disorder (gastroparesis, deep veinthrombosis, venous thromboembolism, previous surgery of the upper gastrointestinaltract, cardiovascular disease, neuromuscular or neurogenic disease, severe vitamin Ddeficiency (cohort 1 and cohort 2), type I or type II diabetes mellitus, glycatedhemoglobin (HbA1c) ≥ 6.5% at screening, history of neoplastic disease, basalcalcitonin level >50 ng/L (50 pg/L) at screening (cohort 2 and cohort 3), history ofacute or chronic pancreatitis or pancreatic amylase or lipase >2×ULN at screening (cohort 2 and cohort 3), prior history of cholecystectomy or untreatedcholelithiasis and personal or family history of medullary thyroid cancer (MTC) ormultiple endocrine neoplasia type 2 (MEN2) (cohort 2 and cohort 3).
History or presence of gastrointestinal, hepatic, or renal disease or any othercondition known to interfere with absorption, distribution, metabolism, or excretionof drugs.
Any clinically important illness, medical/surgical procedure, or trauma.
Any laboratory values with deviations or clinically important abnormalities inclinical 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 theresting 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 importantallergy/hypersensitivity.
Statin treatment within 4 weeks prior to the start of study treatment.
Current use of estrogen-containing products.
Study Design
Study Description
Connect with a study center
Research Site
Glendale, California 91206
United StatesActive - Recruiting
Research Site
Glendale 5352423, California 5332921 91206
United StatesSite Not Available
Research Site
Brooklyn, Maryland 21225
United StatesActive - Recruiting
Research Site
Brooklyn 4349594, Maryland 4361885 21225
United StatesSite Not Available

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