Not yet recruitingPhase 1

A Trial to Assess the Relative Bioavailability of Different Subcutaneous Formulations of AZD9550 and AZD6234

A Phase I, Single-Dose, Randomised, Parallel-Group, Open-Label Trial to Assess the Relative Bioavailability of Different Subcutaneous Formulations of AZD9550 and AZD6234 in Participants Living With Overweight or Obesity

Lead sponsor

AstraZeneca

Assets

AZD6234 / AZD9550

Listed sites

Recruiting sites

Estimated enrollment

Study population

Healthy volunteers, Obesity / overweight

Eligibility highlights

•BMI 25-35•Healthy volunteers

Primary endpoints

•Cmax•Area under the curve from time 0 to the time of last quantifiable concentration•Area under the curve from time 0 extrapolated to infinity (AUCinf)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07911514

Org study IDD8460C00005

Timeline

Milestones

Study first posted2026-11-02actual

Last update posted2026-11-02actual

Study start2026-11-09estimated

Primary completion2027-05-04estimated

Study completion2027-05-04estimated

Assets

Investigational agents

AZD6234 AZD9550

Who this study enrolls

Healthy volunteersObesity / overweight

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy males or non-pregnant, non-lactating females aged 18 to 55 years inclusive

•BMI of 25.0 to 35.0 kg/m2 inclusive and weight ≥50 kg

Exclusion criteria

•History of any clinically important disease or disorder

•History or presence of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric or GI disorder including a history of pancreatitis or gall stones

•History of suicidal ideation or behaviour

•Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of dosing

•History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to any component of the AZD6234 or AZD9550 drug products

•Prior or planned bariatric surgery or placement of a weight loss device

•Participants who do not have suitable veins for multiple venepunctures/cannulation

•Skin disorder/condition or tattoos in the abdominal area of the proposed injection site which can interfere with study assessments

•Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis

•Basal calcitonin level > 50 ng/L

•Any clinically significant abnormal findings in vital signs

•Any clinically significant abnormalities on 12-lead ECG

•HbA1c ≥6.5% (≥48 mmol/mol)

•Evidence of renal impairment

•Females who are pregnant or lactating

•Participants who have received any IMP in the last 90 days prior to dosing

•Participants who have previously received AZD9550 and/or AZD6234

•Treatment with prescription or non-prescription medication intended for weight loss within 3 months before screening

•Treatment with a GLP-1-containing preparation within 3 months before screening

•Treatment with an amylin analogue containing preparation within 30 days before screening

•Treatment with medication for diabetes within 3 months before screening

•Treatment with medication associated with significant weight gain in the 3 months before screening

•Plasma donation within 3 months of screening or any blood donation/loss more than 500 mL within 3 months before screening

•Use of any prescribed or non-prescribed medication including antacids, gastric pH modifying agents, analgesics, herbal remedies, vitamins and minerals within 2 weeks of dosing

•Use of drugs or herbal medications with CYP3A4 enzyme-inducing properties within 3 weeks of dosing

•Current smokers or known or suspected history of alcohol or drug abuse

•Excessive intake of caffeine-containing drinks or food

Endpoints (12)

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.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

9 endpoints

Primary/protocol endpoint

Maximum observed plasma concentration (Cmax)

Time frame:Plasma sample collection from pre dose to Day 22

concentration, descriptive

Primary/protocol endpoint

Area under the curve from time 0 to the time of last quantifiable concentration (AUClast)

Time frame:Plasma sample collection from pre dose to Day 22

concentration, descriptive

Primary/protocol endpoint

Area under the curve from time 0 extrapolated to infinity (AUCinf)

Time frame:Plasma sample collection from pre dose to Day 22

descriptive

Secondary/protocol endpoint

Number of participants with adverse events (AEs)/serious AEs (SAEs), and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests

Time frame:Through study duration, approximately 9 weeks

change from baseline, event

Secondary/protocol endpoint

Time of maximum observed concentration (tmax)

Time frame:Plasma sample collection from pre dose to Day 22

concentration, descriptive

Secondary/protocol endpoint

Terminal elimination half-life (t1/2λz)

Time frame:Plasma sample collection from pre dose to Day 22

concentration, descriptive

Secondary/protocol endpoint

Apparent total body clearance (CL/F)

Time frame:Plasma sample collection from pre dose to Day 22

concentration, descriptive

Secondary/protocol endpoint

Apparent volume of distribution based on the terminal phase (Vz/F)

Time frame:Plasma sample collection from pre dose to Day 22

descriptive

Secondary/protocol endpoint

Mean residence time from time 0 extrapolated to infinity (MRTinf)

Time frame:Plasma sample collection from pre dose to Day 22

descriptive

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Time of last measurable observed concentration (tlast)

Time frame:Plasma sample collection from pre dose to Day 22

concentration, descriptive

Secondary/protocol endpoint/low confidence

Time prior to the first measurable concentration (tlag)

Time frame:Plasma sample collection from pre dose to Day 22

concentration, descriptive

Secondary/protocol endpoint/low confidence

First order rate constant associated with the terminal (log-linear) portion of the curve (λz)

Time frame:Plasma sample collection from pre dose to Day 22

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.