drugset / Trial / NCT06515418

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

NCT06515418

Phase 2 Terminated 204 enrolled BioAge Labs, Inc. Eli Lilly and Company · collab
RandomizedParallel-groupTriple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Azelaprag Small molecule 300 mg Oral
Subject Tirzepatide Peptide 5 mg Subcutaneous

Indications