Study of Exenatide Once-Weekly Suspension in Chinese Patients With Type 2 Diabetes Mellitus

NCT04001231 · Withdrawn

Last updated 2026-05-28

This clinical trial tested a weekly injectable medication called exenatide in Chinese adults with type 2 diabetes to measure how the drug moves through their bloodstream over time.

Status Withdrawn Stopped before any participant enrolled.

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

Type Interventional (clinical trial)

Design open-label (no blinding) study

Who can join Ages 20–75 · all sexes

Timeline Started 2020-06 · est. completion 2021-07

What this study is testing ClinicalTrials.gov NCT04001231 ↗

Description as written by the study sponsor.

The purpose of this study is to evaluate the pharmacokinetics, tolerability, and safety of single and multiple doses of exenatide once-weekly suspension via subcutaneous (SC) injection using a pre-filled, single-dose autoinjector in male and female Chinese with type 2 diabetes.

Treatments tested

Exenatide Once-Weekly Suspension Drug

A single dose will be administered as 2.0-mg dose of exenatide onceweekly suspension via subcutaneous (SC) injection followed by blood samples be drawn for up to 168 hours after the first dose on Day 1 to assess single-dose PK for exenatide once-weekly suspension. Subsequently Patients will receive the second dose of the investigational product (IP) at Visit 6 (Day 8). Thereafter, patients will receive weekly (±1 day) doses of IP up to Visit 18 (Week 14).

Main thing measured	Plasma concentrations versus time profile of exenatide
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04001231 ↗