Study S003257

A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects

ClinicalTrials.gov record

Registration

Registration: NCT05943886
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 164
Start: 2021-08-11
Primary completion: 2023-02-17
Lead sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Conditions: Healthy Subjects; Obesity; T2DM (Type 2 Diabetes Mellitus)
Interventions: DRUG:HEC88473 injection; DRUG:Placebo
Results posted: FALSE

Registered primary outcomes

Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473 [Baseline to day 15]
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473 [Baseline to day 43]
Cmax [Predose and postdose 4、8、10、12、14、24、48、72、96、168、216、336 hours]
AUC [Predose and postdose 4、8、10、12、14、24、48、72、96、168、216、336 hours]

Linked records (2)

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
R0029053	First-in-Human Study on Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Escalating Doses of HEC88473, a Novel Dual GLP-1 and FGF21 Receptor Agonist in Healthy and Obese Chinese Subjects. Zhang H, BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy	2025	Other trial	PMID 40175670 DOI	cites ClinicalTrials.gov:NCT05943886; registry reference DERIVED:40175670
R0029705	Safety and efficacy of GLP-1/FGF21 dual agonist HEC88473 in MASLD and T2DM: A randomized, double-blind, placebo-controlled study. Xiang L, Journal of hepatology	2025	Randomized trial	PMID 39709140 DOI	cites ClinicalTrials.gov:NCT05943886; registry reference DERIVED:39709140