ClinicalTrials.gg
RecruitingNCT07226791Updated Aug 25, 2026

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

A Phase 2 interventional study of AGN-151607-DP and Placebo for AGN-151607-DP in Ventral Hernia, sponsored by AbbVie. Recruiting at 13 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by AbbVie · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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.

02

Conditions studied

  • Ventral Hernia

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Keywords

  • Ventral Hernia
  • AGN-151607-DP
  • Primary fascial closure
  • Open Abdominal Ventral Hernia Repair
03

In context

Hernia, Ventral

230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.

This study's planned enrollment of 200 is above the median of 90 across 153 interventional studies indexed under Hernia, Ventral.

Browse Hernia, Ventral studies →

Lead sponsor

AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- Midline ventral hernia requiring open surgical repair.

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    AGN-151607-DP Dose A

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

    Drug: AGN-151607-DP

  • Experimental
    AGN-151607-DP Dose B

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

    Drug: AGN-151607-DP

  • Experimental
    AGN-151607-DP Dose C

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

    Drug: AGN-151607-DP

  • Placebo comparator
    Placebo for AGN-151607-DP

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

    Drug: Placebo for AGN-151607-DP

Interventions

  • Intramuscular Injection

  • DrugPlacebo for AGN-151607-DP

    Intramuscular Injection

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving Primary Fascial Closure (PFC) Without Use of Component Separation Technique (CST) in Open Ventral Hernia Surgical Repair

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

    Time frame: Up to approximately 1 Month

  2. Percentage of Participants Experiencing Adverse Events

    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.

    Time frame: Up to approximately 25 Months

Secondary outcomes

  1. Percentage of Participants Achieving PFC

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

    Time frame: Up to approximately 1 Month

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

    Percentage of participants with usage of CST will be assessed.

    Time frame: Up to approximately 1 Month

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

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

    Time frame: Up to approximately 1 Month

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

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

    Time frame: Up to approximately 1 Month

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

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

    Time frame: Up to approximately 1 Month

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

    Change in width to the hernia defect will be assessed.

    Time frame: Up to approximately 1 Month

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

    Change in width to the hernia defect will be assessed.

    Time frame: Up to approximately 1 Month

07

Study locations

11 of 13 sites recruiting
  • CARI Clinical Trials INC /ID# 278844
    Riverside, California 92504, United States
    Recruiting
  • University of Florida - Jacksonville /ID# 261992
    Jacksonville, Florida 32209, United States
    Completed

    Not enrolling at this site.

  • Medical Research Center /ID# 278680
    Miami, Florida 33144, United States
    Recruiting
  • Avanza Medical Research Center /ID# 278885
    Pensacola, Florida 32503, United States
    Recruiting
  • NorthShore University-Endeavor Health Evanston Hospital /ID# 277995
    Evanston, Illinois 60201, United States
    Recruiting
  • Integrity Clinical Research /ID# 278710
    Wichita, Kansas 67202, United States
    Completed

    Not enrolling at this site.

  • Mayo Clinic Hospital Rochester /ID# 278995
    Rochester, Minnesota 55905, United States
    Recruiting
  • Novant Health New Hanover Regional Medical Center /ID# 261979
    Wilmington, North Carolina 28401-7407, United States
    Recruiting
    • Site Coordinator · Contact910-465-6679
  • Cleveland Clinic - Cleveland /ID# 277914
    Cleveland, Ohio 44195, United States
    Recruiting
  • Penn State Milton S. Hershey Medical Center /ID# 261987
    Hershey, Pennsylvania 17033-2360, United States
    Recruiting
  • Prisma Health Greenville Memorial Hospital /ID# 261995
    Greenville, South Carolina 29605-4210, United States
    Recruiting
  • Baylor University Medical Center /ID# 261955
    Dallas, Texas 75246, United States
    Recruiting
  • Carilion Roanoke Memorial Hospital /ID# 278577
    Roanoke, Virginia 24014, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Supporting information: Study protocol, Statistical analysis plan

Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2026 (actual). Primary completion is estimated for Sep 2028, 31 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2025
First posted
Nov 10, 2025
StartActual
Feb 4, 2026
Primary completionEst.
Sep 2028
CompletionEst.
May 2030
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07226791
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Nov 10, 2025
Start date
Feb 4, 2026
Primary completion
Sep 2028 (estimated)
Completion
May 2030 (estimated)
Last update
Aug 25, 2026

Study contacts

ABBVIE CALL CENTER
Contact
abbvieclinicaltrials@abbvie.com
844-663-3742
ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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