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NCT Number: NCT07226791

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

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.

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CARI Clinical Trials INC /ID# 278844, Riverside, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AGN-151607-DP

Drug

Intramuscular Injection

Placebo for AGN-151607-DP

Drug

Intramuscular Injection

Primary outcomes

  1. 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

    PFC will be defined as the ability to achieve fascia to fascia midline approximation.

  2. Percentage of Participants Experiencing Adverse Events

    Time frame: 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.

Secondary outcomes

  1. Percentage of Participants Achieving PFC

    Time frame: Up to approximately 1 Month

    PFC will be defined as the ability to achieve fascia to fascia midline approximation.

  2. Percentage of Participants With Usage of CST for the Purpose of PFC

    Time frame: Up to approximately 1 Month

    Percentage of participants with usage of CST will be assessed.

  3. Number of Lateral Abdominal Wall Muscles Released to Achieve PFC

    Time frame: Up to approximately 1 Month

    Number of lateral abdominal wall muscles released to achieve PFC will be assessed.

  4. Change From Baseline in Length of Lateral Abdominal Wall Complex as Measured by Abdominal CT Scan in Supine Position Prior to Surgical Repair

    Time frame: Up to approximately 1 Month

    Change in length of lateral abdominal wall complex will be assessed.

  5. Change From Baseline in Length of Lateral Abdominal Wall Complex as Measured by Abdominal CT Scan Performing Valsalva Maneuver Prior to Surgical Repair

    Time frame: Up to approximately 1 Month

    Change in length of lateral abdominal wall complex will be assessed.

  6. Change From Baseline in Width to the Hernia Defect as Measured by Abdominal CT Scan in Supine Position Prior to Surgical Repair

    Time frame: Up to approximately 1 Month

    Change in width to the hernia defect will be assessed.

  7. Change From Baseline in Width to the Hernia Defect as Measured by Abdominal CT Scan Performing Valsalva Maneuver Prior to Surgical Repair

    Time frame: Up to approximately 1 Month

    Change in width to the hernia defect will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Nov 10, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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