Study to Evaluate Safety and Efficacy of AGN-151607-DP for Closing Belly Wall Without Complex Surgery in Adults Undergoing Open Ventral Hernia Repair

What this Trial Is About

A ventral hernia occurs when the muscles at the front of the belly weaken, allowing organs to push through and form a bulge. This condition can worsen, causing intestines to slip into the bulge, leading to serious pain and health issues. The trial is studying AGN-151607-DP, an investigational drug, to assess its safety and effectiveness in closing the belly wall after open ventral hernia surgery without requiring a complex procedure. Researchers will also monitor adverse events and changes in disease activity. Participants will be randomly assigned to receive one of three different doses of AGN-151607-DP or a matching placebo through intramuscular injection on Day 1. The study plans to enroll approximately 200 adults with midline ventral hernia needing open surgical repair. The total study duration is about 25 months, involving regular weekly visits at hospitals or clinics. During the study, participants will undergo medical assessments, blood tests, and questionnaires to evaluate treatment effects and side effects. Researchers will measure the percentage of participants achieving primary closure of the fascia without using the component separation technique, as well as track adverse events throughout the study period. Monitoring will include imaging and evaluations of changes in abdominal muscle and hernia defect size.

Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants Undergoing Open Abdominal Ventral Hernia Repair