GLP-1 Peptide Atlas, by Delfa

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

Lead sponsor

AstraZeneca

Assets

AZD6234 / AZD9550

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 25-40•Female

Primary endpoints

•AUC from time 0 to infinity (AUCinf) of EE and LEVO•AUC from time of dosing to the last measurable concentration (AUClast) of EE•Cmax of EE and LEVO

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07013643

Org study IDD8750C00006

Timeline

Milestones

Study start2025-06-04actual

Study first posted2025-06-10actual

Last update posted2026-05-11actual

Primary completion2026-12-25estimated

Study completion2026-12-25estimated

Assets

Investigational agents

AZD6234 AZD9550

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age35 Years

Maximum age75 Years

SexFemale

Healthy volunteersAccepted

Inclusion criteria

•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.

Exclusion criteria

•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.

•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.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

16 endpoints

Primary/protocol endpoint

Area under the concentration-time curve from time 0 to infinity (AUCinf) of EE and LEVO

Time frame: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

concentration, descriptive

Primary/protocol endpoint

Area under the concentration-time curve from time of dosing to the last measurable concentration (AUClast) of EE and LEVO

concentration, descriptive

Primary/protocol endpoint

Maximum plasma concentration (Cmax) of EE and LEVO

concentration, descriptive

Primary/protocol endpoint

Time to reach maximum drug concentration in plasma (tmax) of EE and LEVO

time to event, event

Primary/protocol endpoint

Elimination half-life (t1/2λz) of EE and LEVO

concentration, descriptive

Secondary/protocol endpoint

Number of participants with adverse events (AEs)

Time frame:Cohort 1: Up to Day 120; Cohort 2: Up to Day 216; Cohort 3: Up to Day 272; Cohort 4: Up to Day 300

event count, event

Secondary/protocol endpoint

Number of participants developing detectable anti-drug antibodies (ADAs) against AZD6234 and AZD9550

Time frame: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

event count, event

Secondary/protocol endpoint

Area under plasma concentration-time curve from time 0 to 168 hours postdose (AUC0-168h) of AZD6234

Time frame:Cohort 1: At predefined intervals from Day 1 to Day 120

concentration, descriptive

Secondary/protocol endpoint

AUClast of AZD6234

Time frame:Cohort 1: At predefined intervals from Day 1 to Day 120

descriptive

Secondary/protocol endpoint

Cmax of AZD6234

Time frame:Cohort 1: At predefined intervals from Day 1 to Day 120

concentration, descriptive

Secondary/protocol endpoint

AUC0-168h of co-administered AZD6234 and AZD9550

Time frame:Cohort 2: At predefined intervals from Day 8 to Day 216; Cohort 4: At predefined intervals from Day 78 to Day 300

descriptive

Secondary/protocol endpoint

AUClast of co-administered AZD6234 and AZD9550

Time frame:Cohort 2: At predefined intervals from Day 8 to Day 216; Cohort 4: At predefined intervals from Day 78 to Day 300

descriptive

Secondary/protocol endpoint

Cmax of co-administered AZD6234 and AZD9550

Time frame:Cohort 2: At predefined intervals from Day 8 to Day 216; Cohort 4: At predefined intervals from Day 78 to Day 300

concentration, descriptive

Secondary/protocol endpoint

AUC0-168h of AZD9550

Time frame:Cohort 3: At predefined intervals from Day 8 up to Day 272

descriptive

Secondary/protocol endpoint

AUClast of AZD9550

Time frame:Cohort 3: At predefined intervals from Day 8 up to Day 272

descriptive

Secondary/protocol endpoint

Cmax of AZD9550

Time frame:Cohort 3: At predefined intervals from Day 8 up to Day 272

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.