GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 1

A Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in Healthy Participants Aged 18 to 55 Years

A Phase I, Randomized, Single-dose, 3-Period, Open-Label Study to Assess the Pharmacokinetic Formulation Bridging, Safety, and Food Effect of Different Oral Formulations of AZD5004 in Healthy Participants

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI ≥23

Primary endpoints

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

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 IDNCT07455825

Org study IDD7260C00008

Timeline

Milestones

Study start2026-03-05actual

Study first posted2026-03-06actual

Last update posted2026-05-22actual

Primary completion2026-06-03estimated

Study completion2026-06-03estimated

Assets

Investigational agents

AZD5004 / ECC5004

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Eligibility criteria

Main Inclusion Criteria:

•Participants suitable veins for cannulation or repeated venipuncture.

•All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.

•Female participants:

1. of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, to avoid pregnancy.

2. of non-childbearing potential must be confirmed at the Screening Visit.

•Male participants:

1. Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.

2. Additional contraception must be used for the sexual partners of male study participants throughout the clinical study.

•Have a Body Mass Index (BMI) of ≥ 23 kg/m2 but not exceeding 35 kg/m2 inclusive (at the time of Screening) and weigh at least 60 kg.

Main Exclusion Criteria:

•History of any clinically important disease or disorder which, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.

•Any clinically significant illness, medical/surgical procedure, or trauma

•Participants who have a special dietary requirement and who are unable/unwilling to follow a uniform diet.

•Participants positive for anti- hepatitis B core antibody (anti-HBc) or anti-hepatitis C Virus Antibody (anti-HCV).

•Participants who are on or are planning to undertake a weight loss program during the study period.

•Abnormal vital signs, after 10 minutes supine rest, at Screening and/or admission to the Clinical Unit.

•Positive screen for drugs of abuse, or alcohol or cotinine (nicotine).

•Any laboratory values with the deviations specified in protocol and clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.

Endpoints (13)

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.