Clinical Trials

AZD5004 (ECC5004) has been evaluated in multiple Phase 1 and Phase 2 clinical trials sponsored by Eccogene and AstraZeneca, with several completed studies on record. These investigations assess the small-molecule candidate in healthy participants as well as cohorts with type 2 diabetes mellitus, obesity or overweight, hepatic impairment, and renal impairment. Phase 1 trials focused on safety, tolerability, pharmacokinetics, and drug-drug interactions, whereas Phase 2 trials expanded to evaluate therapeutic efficacy and safety across these metabolic and organ-impaired populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07444424 COMPLETED
Healthy Participants
AstraZeneca
 2026-03-13 PHASE1
NCT07455825 COMPLETED
Healthy Participants
AstraZeneca
 2026-03-05 PHASE1
NCT06942936 COMPLETED
Healthy Participants
AstraZeneca
 2025-05-28 PHASE1
NCT06579105 COMPLETED
Diabetes Mellitus, Type 2
AstraZeneca
 2024-10-08 PHASE2
NCT06988553 COMPLETED
Obesity or Overweight; Type 2 Diabetes
Eccogene
 2025-06-17 PHASE1
NCT06579092 COMPLETED
Obesity or Overweight
AstraZeneca
 2024-10-08 PHASE2
NCT06948747 COMPLETED
Healthy Participants
AstraZeneca
 2025-05-06 PHASE1
NCT06813781 COMPLETED
Hepatic Impairment
AstraZeneca
 2024-12-19 PHASE1
NCT06996886 COMPLETED
Healthy Participants
AstraZeneca
 2025-05-22 PHASE1
NCT06857695 COMPLETED
Healthy Participants
AstraZeneca
 2025-03-06 PHASE1
NCT06742762 COMPLETED
Renal Impairment
AstraZeneca
 2024-12-17 PHASE1
NCT06703658 COMPLETED
Healthy Participants; Type 2 Diabetes
AstraZeneca
 2024-11-02 PHASE1
NCT06555822 COMPLETED
Healthy Participants
AstraZeneca
 2024-08-15 PHASE1
NCT06293742 COMPLETED
Type 2 Diabetes Mellitus
Eccogene
 2024-02-08 PHASE1
NCT06268145 COMPLETED
Type 2 Diabetes Mellitus
Eccogene
 2024-02-06 PHASE1
NCT05654831 COMPLETED
Type 2 Diabetes Mellitus
Eccogene
 2022-12-01 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-13)

Check the AZD5004 (ECC5004) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD5004 functions as a small-molecule agonist of the glucagon-like peptide-1 receptor, selectively binding to the receptor to stimulate intracellular cyclic adenosine monophosphate production and induce glucose-dependent insulin secretion. This cellular activation improves metabolic homeostasis and promotes satiety, directly supporting its therapeutic application in clinical trial conditions such as type 2 diabetes mellitus and obesity.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.