GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Japanese Participants and Participants With Type 2 Diabetes Mellitus

A Phase I, Randomised, Single-blind, Placebo-controlled, Single and Repeated Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5004 in Healthy Japanese Participants and With Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Type 2 diabetes

Key I/E criteria

•BMI 18-32•HbA1c ≤6%

Primary endpoints

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

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 IDNCT06703658

Org study IDD7260C00003

Timeline

Milestones

Study start2024-11-02actual

Study first posted2024-11-25actual

Primary completion2025-03-13actual

Study completion2025-03-13actual

Last update posted2025-03-21actual

Assets

Investigational agents

AZD5004 / ECC5004

Study populations

Who this study enrolls

Healthy volunteersType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Japanese men or women, and 18-65 years of age inclusive, at the time of signing the informed consent.

Inclusion Criteria for Part A:

•HbA1c ≤ 6.0%.

•Body weight ≥ 50.0 kg and BMI within the range 18.0-32.0 kg/m2.

Inclusion Criteria for Part B:

•HbA1c ≥ 6.5% and ≤ 10.5%.

•Not on any other diabetic medications.

•Body weight ≥ 60.0 kg and BMI within the range 24.0-35.0 kg/m2

Exclusion criteria

•Has a clinically relevant acute or chronic medical condition or disease.

•History of acute pancreatitis and chronic pancreatitis, gallstones.

•Abnormal renal function.

•Known clinically significant gastric emptying abnormality

•Significant hepatic disease.

•Uncontrolled thyroid disease

Endpoints (32)

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

Glycemic / diabetes

Weight & body composition

2 endpoints

Secondary/protocol endpoint

PartB: % change from baseline to Day 105 in body weight (kg)

Time frame:From Day 1 to Day 105

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

PartB: % change from baseline to Day 105 in waist circumference (cm)

Time frame:From Day 1 to Day 105

Waist circumference, change

percent change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint/low confidence

PartB: AUC0-4 for glucose, insulin and C-peptide for MMTT

Time frame:From Day 1 to Day 105

descriptive

Secondary/protocol endpoint

PartB: Absolute change from baseline to Day 105 in fasting plasma glucose

Time frame:From Day 1 to Day 105

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

PartB: % change from baseline to Day 105 in HOMA-IR

Time frame:From Day 1 to Day 105

HOMA-IR (insulin sensitivity)

percent change from baseline, improvement

Secondary/protocol endpoint

PartB: The proportion of time in hyperglycaemia /hypoglycaemia over the last 7-day intervals at each dose level in CGM

Time frame:From Day 1 to Day 106

descriptive

Safety / tolerability / PK

26 endpoints

Primary/protocol endpoint

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

Time frame:From screening (Day -28) to last follow up visit (Day 8)

Treatment-emergent AEs (any)

event count, event

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

Primary/protocol endpoint

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

Time frame:From screening (Day -28) to last follow up visit (Day 119 )

Serious AEs (any)

event count, event

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

Secondary/protocol endpoint

PartA: Area under the Plasma Concentration vs. Time Curve(AUC0-24)