Recruiting
Phase 2

AGN-151607-DP

Sponsor:

AbbVie

Code:

NCT07226791

Conditions

Ventral Hernia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AGN-151607-DP

Placebo for AGN-151607-DP

Study Details

Brief summary:

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.

Conditions

Ventral Hernia

Study ID

NCT07226791

Start date

Feb 4, 2026

Status verified date

Aug, 2026

Completion date

May, 2030

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AGN-151607-DP Dose A

Participants will receive AGN-151607-DP Dose A on Day 1.

experimental: AGN-151607-DP Dose B

Participants will receive AGN-151607-DP Dose B on Day 1.

experimental: AGN-151607-DP Dose C

Participants will receive AGN-151607-DP Dose C on Day 1.

placebo comparator: Placebo for AGN-151607-DP

Participants will receive Placebo for AGN-151607-DP on Day 1.

Interventions

AGN-151607-DP

Intramuscular Injection

Placebo for AGN-151607-DP

Intramuscular Injection

Primary outcome measure

  • Percentage of Participants Achieving Primary Fascial Closure (PFC) Without Use of Component Separation Technique (CST) in Open Ventral Hernia Surgical Repair [ Time Frame: Up to approximately 1 Month ]
  • Percentage of Participants Experiencing Adverse Events [ Time Frame: Up to approximately 25 Months ]

Central Contacts and Locations

Central contacts

Locations

CARI Clinical Trials INC /ID# 278844

Recruiting

Riverside, California, United States, 92504

Medical Research Center /ID# 278680

Recruiting

Miami, Florida, United States, 33144

Avanza Medical Research Center /ID# 278885

Recruiting

Pensacola, Florida, United States, 32503

NorthShore University-Endeavor Health Evanston Hospital /ID# 277995

Recruiting

Evanston, Illinois, United States, 60201

Mayo Clinic Hospital Rochester /ID# 278995

Recruiting

Rochester, Minnesota, United States, 55905

Novant Health New Hanover Regional Medical Center /ID# 261979

Recruiting

Wilmington, North Carolina, United States, 28401-7407

Contacts

Site Coordinator

910-465-6679

Cleveland Clinic - Cleveland /ID# 277914

Recruiting

Cleveland, Ohio, United States, 44195

Penn State Milton S. Hershey Medical Center /ID# 261987

Recruiting

Hershey, Pennsylvania, United States, 17033-2360

Prisma Health Greenville Memorial Hospital /ID# 261995

Recruiting

Greenville, South Carolina, United States, 29605-4210

Baylor University Medical Center /ID# 261955

Recruiting

Dallas, Texas, United States, 75246

Carilion Roanoke Memorial Hospital /ID# 278577

Recruiting

Roanoke, Virginia, United States, 24014

More Information

Sponsor

AbbVie

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Ventral Hernia
  • AGN-151607-DP
  • Primary fascial closure
  • Open Abdominal Ventral Hernia Repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-25.