GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study in Healthy Participants to Investigate Relative Bioavailability of AZD5004 in Three Solid Oral Formulations

An Open-Label, Randomized, Four-Treatment, Four-Period, Single-Dose Crossover Study in Healthy Participants to Assess the Relative Bioavailability of AZD5004 in Three Solid Oral Formulations (F1, F3, F4)

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI ≥23•Healthy volunteers

Primary endpoints

•Area under concentration-time curve from time 0 to infinity (AUCinf)•Area under concentration-curve from time 0 to the 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 IDNCT06996886

Org study IDD7260C00012

Timeline

Milestones

Study start2025-05-22actual

Study first posted2025-05-30actual

Primary completion2025-07-15actual

Study completion2025-07-25actual

Last update posted2025-07-31actual

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:

•Healthy male and female participants with suitable veins for cannulation or repeated venipuncture.

•Female participants:

1. Female(s) of childbearing potential: If heterosexually active must agree to use an approved method of highly effective contraception.

2. Female(s) not of childbearing potential

•Male participants:

1. Condom use is required for the duration of the clinical study.

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

•Have a Body Mass Index (BMI) ≥ 23 kg/m2 and 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, in the opinion of the Investigator, 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

•History of acute pancreatitis (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy), chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase.

•Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract (including bariatric surgery).

•Any clinically important illness, medical/surgical procedure, or trauma.

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

•Any positive result at Screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) or Human immunodeficiency Virus (HIV).

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

•Serum triglyceride concentrations above 1000 mg/dL (11 mmol/L).

•Basal calcitonin level > 50 ng/L or pg/mL at Screening or history/family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN), type 2.

•Known or suspected history of alcohol or drug abuse or excessive intake of alcohol

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

•History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5004.

•Excessive intake of caffeine-containing drinks or food

•History of psychosis or bipolar disorder and major depressive disorder.

•History of suicide attempt or history of suicidal ideation within the past year.

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.