Healthy ParticipantsPhase 1NCT07013643
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
A Phase 1 study testing AZD6234, Ethinyl estradiol/Levonorgestrel (EE/LEVO) and Acetaminophen (APAP) in people with Healthy Participants, run by AstraZeneca at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD6234, Ethinyl estradiol/Levonorgestrel (EE/LEVO) and Acetaminophen (APAP)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jun 2025to 9 Jul 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Brooklyn, Maryland, 21225
Research Site
Glendale, California, 91206
About this study
Official title: 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
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.
Read the detailed description
This is a Phase I, open-label, single-sequence, multiple-cohort study which will be performed at multiple study sites in healthy females of childbearing and non-childbearing potential.
The purpose of this study is to investigate the effect of AZD6234, AZD9550 and a combination of AZD9550 and AZD6234 on the PK, safety and tolerability of a CoC, ethinyl estradiol/levonorgestrel (EE/LEVO).
The study will have 4 cohorts, and each cohort will consist of 5 periods which include, Screening, Start, Up-titration, Maintenance, and Follow-up periods.
- Conditions
- Healthy Participants
- Being tested
- AZD6234, Ethinyl estradiol/Levonorgestrel (EE/LEVO), Acetaminophen (APAP), AZD9550
- Keywords
- Obesity, Overweight, Oral contraceptives, Pharmacokinetics, Drug Interaction
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6234Drug
AZD6234 will be administered as a subcutaneous injection in the abdomen.
Ethinyl estradiol/Levonorgestrel (EE/LEVO)Drug
EE/LEVO will be administered as combined oral tablets.
Acetaminophen (APAP)Drug
APAP will be administered orally as a solution.
AZD9550Drug
AZD9550 will be administered as a subcutaneous injection in the abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Cohort-1: AZD6234 + EE/LEVO + Acetaminophen (APAP) | Experimental | All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 administration. Receives: Drug: AZD6234; Drug: Ethinyl estradiol/Levonorgestrel (EE/LEVO); Drug: Acetaminophen (APAP) |
| Cohort-2: AZD6234+AZD9550+EE/LEVO+APAP | Experimental | All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 (up to a maximum dose of Dose X1) and AZD9550 (up to a maximum dose of Dose Y1) administration. Receives: Drug: AZD6234; Drug: Ethinyl estradiol/Levonorgestrel (EE/LEVO); Drug: Acetaminophen (APAP); Drug: AZD9550 |
| Cohort-3: AZD9550 + EE/LEVO + APAP | Experimental | All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD9550 administration. Receives: Drug: Ethinyl estradiol/Levonorgestrel (EE/LEVO); Drug: Acetaminophen (APAP); Drug: AZD9550 |
| Cohort-4: AZD6234+AZD9550+EE/LEVO+APAP | Experimental | All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 (up to a maximum dose of Dose X2) and AZD9550 (up to a maximum dose of Dose Y1) administration. Receives: Drug: AZD6234; Drug: Ethinyl estradiol/Levonorgestrel (EE/LEVO); Drug: Acetaminophen (APAP); Drug: AZD9550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time 0 to infinity (AUCinf) of EE and LEVO
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
Measured: Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253
Area under the concentration-time curve from time of dosing to the last measurable concentration (AUClast) of EE and LEVO
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
Measured: Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253
Maximum plasma concentration (Cmax) of EE and LEVO
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
Measured: Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253
Time to reach maximum drug concentration in plasma (tmax) of EE and LEVO
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
Measured: Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253
Elimination half-life (t1/2λz) of EE and LEVO
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
Measured: Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253
Secondary outcomes (11)
Number of participants with adverse events (AEs)
To assess the safety and tolerability of AZD6234, co-administered AZD9550 and AZD6234, and AZD9550 with CoC EE/LEVO.
Measured: Cohort 1: Up to Day 120; Cohort 2: Up to Day 216; Cohort 3: Up to Day 272; Cohort 4: Up to Day 300
Number of participants developing detectable anti-drug antibodies (ADAs) against AZD6234 and AZD9550
To assess the immunogenicity of AZD6234, co-administered AZD9550 and AZD6234, and AZD9550 with CoC EE/LEVO.
Measured: Cohort 1: At predefined intervals from Day -2 up to Day 120; Cohort 2: At predefined intervals from Day -2 up to Day 216; Cohort 3: At predefined intervals from Day -2 up to Day 272; ; Cohort 4: At predefined intervals from Day -2 up to Day 300
Area under plasma concentration-time curve from time 0 to 168 hours postdose (AUC0-168h) of AZD6234
To characterize the PK of single and multiple doses of AZD6234.
Measured: Cohort 1: At predefined intervals from Day 1 to Day 120
AUClast of AZD6234
To characterize the PK of single and multiple doses of AZD6234.
Measured: Cohort 1: At predefined intervals from Day 1 to Day 120
Cmax of AZD6234
To characterize the PK of single and multiple doses of AZD6234.
Measured: Cohort 1: At predefined intervals from Day 1 to Day 120
AUC0-168h of co-administered AZD6234 and AZD9550
To characterize the PK of single and multiple doses of co-administered AZD6234 and AZD9550.
Measured: Cohort 2: At predefined intervals from Day 8 to Day 216; Cohort 4: At predefined intervals from Day 78 to Day 300
AUClast of co-administered AZD6234 and AZD9550
To characterize the PK of single and multiple doses of co-administered AZD6234 and AZD9550.
Measured: Cohort 2: At predefined intervals from Day 8 to Day 216; Cohort 4: At predefined intervals from Day 78 to Day 300
Cmax of co-administered AZD6234 and AZD9550
To characterize the PK of single and multiple doses of co-administered AZD6234 and AZD9550.
Measured: Cohort 2: At predefined intervals from Day 8 to Day 216; Cohort 4: At predefined intervals from Day 78 to Day 300
AUC0-168h of AZD9550
To characterize the PK of single and multiple doses of AZD9550.
Measured: Cohort 3: At predefined intervals from Day 8 up to Day 272
AUClast of AZD9550
To characterize the PK of single and multiple doses of AZD9550.
Measured: Cohort 3: At predefined intervals from Day 8 up to Day 272
Cmax of AZD9550
To characterize the PK of single and multiple doses of AZD9550.
Measured: Cohort 3: At predefined intervals from Day 8 up to Day 272
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start4 Jun 2025
- Primary completion9 Jul 2027 (estimated)
- Study completion9 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013643
- Sponsor's protocol ID
- D8750C00006
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.