AGN-151607-DP to help close the belly wall after open midline ventral hernia repair
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
Run by AbbVie · NCT07226791 · Data updated 2026-11-12
This trial tests whether a single intramuscular dose of AGN-151607-DP helps safely close the belly wall in adults having open midline ventral hernia repair.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 13 sites (Riverside, California and 12 other locations) |
| Status | Recruiting |
| Started | February 4, 2026 |
| Main results expected | September 2028 |
| Study ends | May 2030 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT07226791 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a midline ventral hernia who require open surgical repair and who do not have excluded neuromuscular conditions or recent abdominal/hernia surgery are the intended candidates.
✕Probably not a fit
People with diagnosed neuromuscular disorders (for example Duchenne muscular dystrophy, myasthenia gravis, ALS, mitochondrial disease) or those who had abdominal or hernia repair within the prior 6 months are unlikely to benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2, randomized, placebo-controlled trial will enroll about 200 adults undergoing open midline ventral hernia repair across roughly 30 U.S. sites. Participants are randomly assigned to receive a single intramuscular injection of AGN-151607-DP or matching placebo on Day 1, and are followed for adverse events and change in disease activity related to fascial closure. The study specifically examines whether the drug can enable primary fascial closure without requiring more complex surgical techniques. Total study duration for participants is approximately 25 months with scheduled follow-up visits.
Why it matters
Potential benefit: If successful, the drug could make primary fascial closure safer and reduce the need for more complex repair techniques.
How similar studies have gone: This approach is relatively novel, with limited prior clinical evidence for intramuscular pharmacologic agents specifically used to aid fascial closure in ventral hernia repair.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Midline ventral hernia requiring open surgical repair. Exclusion Criteria: * Medical condition that may put the participant at increased risk with exposure to AGN-151607-DP, including diagnosed muscular dystrophy (e.g., Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function. * History of abdominal or hernia repair surgery requiring hospitalization within 6 months prior to screening.
Where it's running
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CARI Clinical Trials INC /ID# 278844
Riverside, California, United States Recruiting -
Medical Research Center /ID# 278680
Miami, Florida, United States Recruiting -
Avanza Medical Research Center /ID# 278885
Pensacola, Florida, United States Recruiting -
NorthShore University-Endeavor Health Evanston Hospital /ID# 277995
Evanston, Illinois, United States Recruiting -
Mayo Clinic Hospital Rochester /ID# 278995
Rochester, Minnesota, United States Recruiting -
Novant Health New Hanover Regional Medical Center /ID# 261979
Wilmington, North Carolina, United States Recruiting
Show 7 more locations
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Cleveland Clinic - Cleveland /ID# 277914
Cleveland, Ohio, United States Recruiting -
Penn State Milton S. Hershey Medical Center /ID# 261987
Hershey, Pennsylvania, United States Recruiting -
Prisma Health Greenville Memorial Hospital /ID# 261995
Greenville, South Carolina, United States Recruiting -
Baylor University Medical Center /ID# 261955
Dallas, Texas, United States Recruiting -
Carilion Roanoke Memorial Hospital /ID# 278577
Roanoke, Virginia, United States Recruiting -
University of Florida - Jacksonville /ID# 261992
Jacksonville, Florida, United States Completed -
Integrity Clinical Research /ID# 278710
Wichita, Kansas, United States Completed
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
Similar studies
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This study tests if a special program that helps people change unhealthy habits can reduce complications after surgery for ventral hernia repair.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.