Study S000819

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered HRS9531

ClinicalTrials.gov record

Registration

Registration: NCT05152277
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 90
Start: 2021-12-06
Primary completion: 2022-08-24
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions: Type 2 Diabetes
Interventions: DRUG:HRS9531; OTHER:placebo
Results posted: FALSE
Individual participant data sharing: UNDECIDED

Registered primary outcomes

Number of Adverse Events [Start of Treatment to end of study (approximately 7 weeks or 9 weeks)]

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
R0007327	Preclinical and First-In-Human Evaluation of Ribupatide (HRS9531), a Dual GLP-1/GIP Receptor Agonist. He K, Diabetes, obesity & metabolism	2026	Randomized trial	PMID 42764407 DOI	cites ClinicalTrials.gov:NCT05152277; registry reference DERIVED:42764407
R0047935	763-P: Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of a Dual GLP-1/GIP Receptor Agonist (HRS9531) in Healthy Subjects—A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose (SAD and MAD) Study Kun He, Diabetes	2023	Randomized trial	DOI	cites ClinicalTrials.gov:NCT05152277