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

NCT07226791 · tracked via the Priya Life Science USA tracker

Sponsor

AbbVie

Phase

Phase 2

Started

2026-02-04

Last updated

2026-08-25

Condition(s) studied

Ventral Hernia

Investigational drug(s) / intervention(s)

AGN-151607-DPPlacebo for AGN-151607-DP

AGN-151607-DP: Intramuscular Injection

Placebo for AGN-151607-DP: Intramuscular Injection

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

Percentage of Participants Achieving Primary Fascial Closure (PFC) Without Use of Component Separation Technique (CST) in Open Ventral Hernia Surgical Repair — Up to approximately 1 Month
PFC will be defined as the ability to achieve fascia to fascia midline approximation.
Percentage of Participants Experiencing Adverse Events — Up to approximately 25 Months
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Trial sites (13)

Facility	City	Region	Status
CARI Clinical Trials INC /ID# 278844	Riverside	California	Recruiting
University of Florida - Jacksonville /ID# 261992	Jacksonville	Florida	Completed
Medical Research Center /ID# 278680	Miami	Florida	Recruiting
Avanza Medical Research Center /ID# 278885	Pensacola	Florida	Recruiting
NorthShore University-Endeavor Health Evanston Hospital /ID# 277995	Evanston	Illinois	Recruiting
Integrity Clinical Research /ID# 278710	Wichita	Kansas	Completed
Mayo Clinic Hospital Rochester /ID# 278995	Rochester	Minnesota	Recruiting
Novant Health New Hanover Regional Medical Center /ID# 261979	Wilmington	North Carolina	Recruiting
Cleveland Clinic - Cleveland /ID# 277914	Cleveland	Ohio	Recruiting
Penn State Milton S. Hershey Medical Center /ID# 261987	Hershey	Pennsylvania	Recruiting
Prisma Health Greenville Memorial Hospital /ID# 261995	Greenville	South Carolina	Recruiting
Baylor University Medical Center /ID# 261955	Dallas	Texas	Recruiting
Carilion Roanoke Memorial Hospital /ID# 278577	Roanoke	Virginia	Recruiting

More AbbVie trials in the USA

Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17) Recruiting

Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer Active, not recruiting

A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) Active, not recruiting

RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD) Active, not recruiting

A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma Active, not recruiting

Other trials for the same condition

Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair) Active, not recruiting

AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07226791 on ClinicalTrials.gov ↗ ← All trials in the USA