A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly Suspension

NCT00894322 · Completed

Last updated 2026-05-28

This clinical trial tests a once-weekly injection of exenatide in healthy adults to study how the drug is absorbed, tolerated, and its safety.

Status Completed The study has finished.

Phase Phase1, Phase2

Type Interventional (clinical trial)

Design Randomized, single-blind treatment study

Participants 65 people

Who can join Ages 19–75 · all sexes

Timeline Started 2009-04 · est. completion 2009-08

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT00894322 ↗

Description as written by the study sponsor.

This study is designed to evaluate the pharmacokinetics, tolerability, and safety of exenatide once weekly suspension in both healthy subjects and in subjects with type 2 diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. Development of this exenatide once weekly presentation would eliminate the need to reconstitute the product prior to use.

Treatments tested

exenatide once weekly Drug

subcutaneous injection, 10.0 mg, single injection
exenatide once weekly Drug

subcutaneous injection, 2.0 mg, once a week for 12 weeks
Placebo Other

subcutaneous injection, volume equivalent to Cohort 2 experimental intervention, once a week for 12 weeks

Main thing measured	Area Under the Curve (AUC) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00894322 ↗