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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azelaprag | Small molecule | 300 mg | Oral |
| Subject | Tirzepatide | Peptide | 5 mg | Subcutaneous |