Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

273

Participants

Timeline

Start Date

April 27, 2020

Primary Completion Date

March 30, 2022

Study Completion Date

November 28, 2022

Conditions
Type 2 Diabetes Mellitus (T2DM)
Interventions
DRUG

GLP-1 receptor agonist

PB-119 is an investigational pegylated human glucagon-like peptide-1 (GLP-1) receptor agonist. The dosing regimen is 150μg once every week as subcutaneous administration. Patients in PB-119 group will be administered the active drugs for 52 weeks (24+28).

DRUG

Placebo

PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.

Trial Locations (1)

Unknown

Central South University The Second Xiangya Hospital, Changsha

All Listed Sponsors
lead

PegBio Co., Ltd.

OTHER

NCT04504370 - Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects | Biotech Hunter | Biotech Hunter