GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study to Investigate Multiple Ascending Doses and Relative Bioavailability of AZD5004 in Healthy Participants

A Phase I, Two-Part Study in Healthy Volunteers Consisting of a Randomized, Single-blind, Placebo-controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5004 and a Randomized, Open-Label, Two-way Cross-over Study to Compare the Relative Bioavailability of Two Oral Tablet Strengths of AZD5004

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

•Serious AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))•Part B

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 IDNCT06555822

Org study IDD7260C00004

Timeline

Milestones

Study first posted2024-08-15actual

Study start2024-08-15actual

Primary completion2025-03-06actual

Study completion2025-03-06actual

Last update posted2025-03-17actual

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

Inclusion criteria

•Must have suitable veins for cannulation or repeated venipuncture.

•Female(s) of Childbearing Potential must use adequate contraception (oral contraceptives are not permitted).

•Have a BMI ≥ 23 kg/m2 and not exceeding 35 kg/m2 inclusive and weigh at least 60 kg.

•No or off statin treatment for ≥ 4 weeks prior to the study treatment.

Exclusion criteria

•History of any clinically important disease or disorder.

•History of acute pancreatitis, chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase.

•History or presence of gastrointestinal, hepatic, or renal disease.

•Clinically significant hepatic disease, inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper gastrointestinal tract.

•Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.

•Any clinically important abnormalities in rhythm, blood pressure, heart rate, conduction or morphology of the resting electrocardiogram (ECG).

•Uncontrolled thyroid disease, defined as thyroid-stimulating hormone > 6.0 mIU/L or < 0.4 mIU/L at Screening.

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

•History of severe allergy/hypersensitivity or excessive intake of caffeine-containing drinks or food.

•Use of any prescribed or nonprescribed medication including antacids or analgesics.

•Participants who are on or are planning to undertake a weight loss program.

•History of psychosis, major depressive disorder, suicide attempt or suicidal ideation within the past year.

•Lactating, breastfeeding, or pregnant females or females who intend to become pregnant.

•Participants who are vegans or have medical dietary restrictions.

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.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Part A: Percentage change from Baseline in body weight (kg)

Time frame:Baseline (Day - 2) to Days 49, 91, and 106

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Part A: Absolute change from Baseline in body weight (kg)

Time frame:Baseline (Day - 2) to Days 49, 91, and 106

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Part A: Percentage change from Baseline in Body Mass Index (BMI) (kg/m^2)

Time frame:Baseline (Day - 2) to Days 49, 91, and 106

BMI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Part A: Absolute change from Baseline in BMI (kg/m^2)

Time frame:Baseline (Day - 2) to Days 49, 91, and 106

BMI, change

change from baseline, improvement

Safety / tolerability / PK

12 endpoints

Primary/protocol endpoint

Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Time frame:From screening (Day -28) to last follow up visit (Day 120)

Serious AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Primary/protocol endpoint

Part B: Maximum observed plasma (peak) drug concentration (Cmax) of AZD5004

Time frame:From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)

Cmax

concentration, descriptive

Primary/protocol endpoint

Part B: Area under the concentration-curve from time zero to the last quantifiable concentration (AUClast)

Time frame:From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)

concentration, descriptive

Primary/protocol endpoint

Part B: Area under concentration-time curve from time 0 to infinity (AUCinf)

Time frame:From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Part B: Time to reach maximum observed concentration (tmax)

Time frame:From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)

Tmax

descriptive

Secondary/protocol endpoint

Part A: Maximum observed plasma (peak) drug concentration (Cmax) of AZD5004