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

NCT04504370 · Completed

Last updated 2026-05-28

This clinical trial tests the safety and effectiveness of a new injectable medication called PB-119 in people with type 2 diabetes who have not yet taken diabetes medications.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 273 people

Who can join Ages 18–75 · all sexes

Timeline Started 2020-04 · est. completion 2022-11

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT04504370 ↗

Description as written by the study sponsor.

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of PB-119 in Drug-naïve T2DM Subjects.

Treatments tested

GLP-1 receptor agonist Drug

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).
Placebo also known as PB-119 Placebo Drug

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

Main thing measured	Change in HbA1c
Sponsor	PegBio Co., Ltd.
Conditions studied	Type 2 Diabetes Mellitus (T2DM)
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04504370 ↗