GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus

A Phase Ib, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus

Lead sponsor

Eccogene

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≤35•HbA1c 7-10.5%

Primary endpoint

•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any), Discontinuation due to AE, Death (safety endpoint))

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 IDNCT06988553

Org study IDD7260C00005

Timeline

Milestones

Study first posted2025-05-25actual

Study start2025-06-17actual

Primary completion2025-11-28actual

Study completion2025-11-28actual

Last update posted2025-12-23actual

Assets

Investigational agents

AZD5004 / ECC5004

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age74 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Aged 18 to 74 years inclusive at the time of signing the informed consent.

•Stable self-reported body weight for 3 months prior to Screening.

Inclusion Criteria for Cohort A:

- 27 kg/m2 ≤ BMI ≤ 35 kg/m2 and weigh at least 60 kg at Screening.

Inclusion Criteria for Cohort B:

•Diagnosed with T2DM for at least 6 months prior to signing the informed consent.

•HbA1c value at Screening of ≥ 7.0% and ≤ 10.5%

•BMI of ≥ 24 kg/m2 at the Screening Visit.

Exclusion criteria

•History of, or any existing condition that influence the participant's ability to participate or affect the interpretation of the results of the study.

•Known clinically significant gastric emptying abnormality.

•Significant hepatic disease.

•Abnormal renal function.

•History of acute pancreatitis and chronic pancreatitis, gallstones.

•Uncontrolled thyroid disease.

Endpoints (7)

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.

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse event leading to the discontinuation of study intervention (DAEs), death, and Adverse events of special interest (AESIs)

Time frame:From baseline to week 16.

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any), Discontinuation due to AE, Death (safety endpoint)

Secondary/protocol endpoint

AZD5004 concentrations in plasma

Time frame:Week 16.

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Area under the concentration-time curve over a dosing interval (AUCtau)

Time frame:Week 16.

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax)

Time frame:Week 16.

Cmax

concentration, descriptive

Secondary/protocol endpoint

Half-Life (t1/2)

Time frame:Week 16.

Half-life

descriptive

Secondary/protocol endpoint

Time of Occurrence of Maximum Plasma Concentration (tmax)

Time frame:Week 16.

Tmax

descriptive

Secondary/protocol endpoint

Trough concentration (Ctrough)

Time frame:Week 16.

Plasma concentration (steady state)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 July 1, 2026 snapshot.