A Phase I Study of Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes

NCT01965496 · Completed

Last updated 2026-05-28

This clinical trial tested a new diabetes medication called polyethylene glycol loxenatide in adults with type 2 diabetes to see how it affects blood sugar levels over 14 weeks.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 64 people

Who can join Ages 20–70 · all sexes

Timeline Started 2012-03 · est. completion 2013-04

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT01965496 ↗

Description as written by the study sponsor.

Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1) analogue that created on the basis of the Exenatide and modified by polyethylene glycol (PEG). This study aims to evaluate whether the titration mode of administration could reduce the incidence of adverse reactions of PEX168, also decided to observe long-term continuous administration of PK/PD correlation.

Treatments tested

PEX168 also known as Polyethylene Glycol Loxenatide Drug

A injection administered subcutaneously

Main thing measured	To assess HbA1C levels after 14 weeks continuous treatment
Sponsor	Jiangsu HengRui Medicine Co., Ltd.
Conditions studied	Type 2 Diabetes
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01965496 ↗