Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over
Public ClinicalTrials.gov record NCT06515418. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Proof-of-Concept Study to Investigate Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over (STRIDES)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06515418
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 204 participants
Conditions and interventions
Conditions
Interventions
- Oral Azelaprag (BGE-105) Drug
- Oral Placebo for Azelaprag (BGE-105) Drug
- Tirzepatide Drug
- Tirzepatide Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 55 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 26, 2024
- Primary completion
- Feb 5, 2025
- Completion
- Feb 11, 2025
- Last update posted
- Mar 12, 2025
2024 – 2025
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 110 | Mesa | Arizona | 85210 | — |
| Site 107 | Los Angeles | California | 90057 | — |
| Site 103 | Montclair | California | 91763 | — |
| Site 105 | Spring Valley | California | 91978 | — |
| Site 100 | Louisville | Kentucky | 40213 | — |
| Site 101 | Marrero | Louisiana | 70072 | — |
| Site 112 | Boston | Massachusetts | 02114 | — |
| Site 111 | Troy | Michigan | 48098 | — |
| Site 113 | City of Saint Peters | Missouri | 63303 | — |
| Site 106 | Butte | Montana | 59701 | — |
| Site 109 | Fargo | North Dakota | 58104 | — |
| Site 108 | Beachwood | Ohio | 44122 | — |
| Site 102 | Dallas | Texas | 75230 | — |
| Site 104 | St. George | Utah | 84790 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06515418, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 12, 2025 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06515418 live on ClinicalTrials.gov.