Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-05-11
50
Participants Needed
2
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Negative pregnancy test at Screening and admission
- Females of childbearing potential must not be lactating
- Heterosexually active females must agree to use approved highly effective contraception excluding hormonal and estrogen-containing methods
- Females of non-childbearing potential must be confirmed at Screening
- Body Mass Index between 25 and 40 kg/m2 inclusive
- Weight of at least 60 kg
You will not qualify if you...
- History of clinically important diseases such as gastroparesis, deep vein thrombosis, venous thromboembolism, cardiovascular disease, neuromuscular or neurogenic disease
- Severe vitamin D deficiency in cohorts 1 and 2
- Type I or II diabetes mellitus or HbA1c ≥ 6.5% at screening
- History of neoplastic disease
- Elevated basal calcitonin >50 ng/L in cohorts 2 and 3
- History of pancreatitis or pancreatic enzyme elevation in cohorts 2 and 3
- Prior cholecystectomy or untreated gallstones
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 in cohorts 2 and 3
- Gastrointestinal, hepatic, or renal disease affecting drug absorption or metabolism
- Any clinically important illness, medical or surgical procedure, or trauma
- Significant lab abnormalities
- Positive tests for Hepatitis B surface antigen, Hepatitis B core antibody, or HIV
- Abnormal vital signs
- ECG abnormalities
- Current smokers or nicotine users
- History or suspicion of alcohol or drug abuse or excessive alcohol intake
- Severe allergy or ongoing important allergy/hypersensitivity
- Statin use within 4 weeks prior to study
- Current use of estrogen-containing products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Research Site
Glendale, California, United States, 91206
Actively Recruiting
2
Research Site
Brooklyn, Maryland, United States, 21225
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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