Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants Undergoing Open Abdominal Ventral Hernia Repair
Public ClinicalTrials.gov record NCT07226791. 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 Double-Blind, Placebo-Controlled, Adaptive, Dose-Escalation Study to Evaluate the Safety and Efficacy of AGN-151607-DP (USAN: gemibotulinumtoxinA) for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique, in Subjects Undergoing Open Abdominal Ventral Hernia Repair
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A ventral hernia happens when the muscles in the front of your belly become weak and let organs push through, causing a bulge. If it gets worse, intestines can slip into the bulge, leading to serious pain and health problems. This study aims to asses if AGN-151607-DP is safe and effective for closing the belly wall after open ventral hernia surgery, without needing a complex procedure. Adverse Events and change in disease activity will be assessed. AGN-151607-DP is an investigational drug being developed to treat ventral hernia. Participants will be randomly placed in treatment groups to receive either AGN151607-DP or matching placebo. Approximately 200 adult participants with midline ventral hernia needing open surgical repair will be enrolled in approximately 30 sites in the United States. Participants will receive intramuscular injections of AGN-161607-DP or matching placebo on Day 1. Duration of the study is approximately 25 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT07226791
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- 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
- Feb 3, 2026
- Primary completion
- Aug 31, 2028
- Completion
- Apr 30, 2030
- Last update posted
- Aug 24, 2026
2026 – 2030
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CARI Clinical Trials INC /ID# 278844 | Riverside | California | 92504 | Recruiting |
| University of Florida - Jacksonville /ID# 261992 | Jacksonville | Florida | 32209 | Completed |
| Medical Research Center /ID# 278680 | Miami | Florida | 33144 | Recruiting |
| Avanza Medical Research Center /ID# 278885 | Pensacola | Florida | 32503 | Recruiting |
| NorthShore University-Endeavor Health Evanston Hospital /ID# 277995 | Evanston | Illinois | 60201 | Recruiting |
| Integrity Clinical Research /ID# 278710 | Wichita | Kansas | 67202 | Completed |
| Mayo Clinic Hospital Rochester /ID# 278995 | Rochester | Minnesota | 55905 | Recruiting |
| Novant Health New Hanover Regional Medical Center /ID# 261979 | Wilmington | North Carolina | 28401-7407 | Recruiting |
| Cleveland Clinic - Cleveland /ID# 277914 | Cleveland | Ohio | 44195 | Recruiting |
| Penn State Milton S. Hershey Medical Center /ID# 261987 | Hershey | Pennsylvania | 17033-2360 | Recruiting |
| Prisma Health Greenville Memorial Hospital /ID# 261995 | Greenville | South Carolina | 29605-4210 | Recruiting |
| Baylor University Medical Center /ID# 261955 | Dallas | Texas | 75246 | Recruiting |
| Carilion Roanoke Memorial Hospital /ID# 278577 | Roanoke | Virginia | 24014 | Recruiting |
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 NCT07226791, 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 Aug 24, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07226791 live on ClinicalTrials.gov.