Study S002988

A Randomized, Double-Blind, Placebo-Controlled, Single and Repeated Dose Escalation, First-Time-In-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ECC5004 in Healthy Participants and in Patients With Type 2 Diabetes Mellitus

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT05654831
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: TRIPLE
Status: COMPLETED
Enrollment: 69
Start: 2022-12-01
Primary completion: 2023-11-01
Lead sponsor: Eccogene
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Placebo; DRUG:ECC5004
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations [SAD: Up to Day 8 and MAD: Up to Day 35]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0007796	Non-clinical and first-in-human characterization of ECC5004/AZD5004, a novel once-daily, oral small-molecule GLP-1 receptor agonist. Haggag AZ, Diabetes, obesity & metabolism	2025	Randomized trial	PMID 39495140 DOI	cites ClinicalTrials.gov:NCT05654831; registry reference DERIVED:39495140