Clinical trial Recruiting at 11 sites Phase 2 Interventional Ages 18 to 80

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.

More Ventral Hernia trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment200 (estimated)
SponsorAbbVie
Industry-sponsored
Locations13 sites (Riverside, California and 12 other locations)
StatusRecruiting
StartedFebruary 4, 2026
Main results expectedSeptember 2028
Study endsMay 2030
Registry record updatedAugust 25, 2026
Trial IDNCT07226791 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.