Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over

Summary

This study aims to find out how well a combination of oral azelaprag taken once a day (QD) or twice a day (BID), along with a weekly injection of tirzepatide, works for weight management in adults 55 years and older. The researchers are also looking at safety. Estimated Study Length: * with the optional prescreening, the study duration may be up to 48 weeks. * the treatment duration will be 24 weeks followed by 12 weeks follow-up. * the visit frequency will be every 2 weeks for the first 8 weeks of the treatment period and every 4 weeks thereafter.

Timeline

Start

2024-06-27

Primary completion

2025-02-06

Completion

2025-02-12

Outcome

Outcome not reported

Stopped: “Dosing of both study drugs has been discontinued due to observation of liver transaminitis without clinically significant symptoms in some subjects receiving azelaprag. All participant visits have been completed.”

Drugs

Indications