Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy

NCT04504396 · Completed

Last updated 2026-05-28

This clinical trial is testing the safety and effectiveness of the medication PB-119 in adults with type 2 diabetes whose blood sugar is not well-controlled by metformin alone.

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 620 people

Who can join Ages 18–75 · all sexes

Timeline Started 2020-06 · est. completion 2023-05

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT04504396 ↗

Description as written by the study sponsor.

This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of PB-119 to subjects with type 2 diabetes mellitus (T2DM) not well-controlled by metformin monotherapy.

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 NCT04504396 ↗