NCT07226791ClinicalTrials.gov
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 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
In brief
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…
Phase 2200 participants sought13 sites1 country
Registered in 1 registry
- ClinicalTrials.govNCT07226791Open this record at ClinicalTrials.govSynced 4 weeks ago
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Trial information is shown as published by the registry, in its original language.
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How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2025-11-10; recorded start 2026-02-04
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Present: Participants are randomly assignedAllocation is recorded as randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Present: Uses blinding (masking)A masking level is recorded in the record
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 378 other studies in this databaseCounted from the lead sponsor named in the record (AbbVie)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 1 condition.
- Lead sponsor type recorded as: industry.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
A definitive-grade design for a phase 2 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation20/20
Participants are randomly allocated between arms
- Blinding20/20
Quadruple-blind
- Control arm13/15
Placebo / sham control arm
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
- Multi-centre8/8
Multi-centre: 12 sites
- Data monitoring committee7/7
A data monitoring committee is in place
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A medium-sized study: 200 participants (target), run at 13 sites.
How this score is built
- Enrolment22/40
200 participants (target)
- Site count13/25
12 sites
- Country count0/15
Single country
- Planned duration9/10
Planned over about 52 months
- Sponsor scale9/10
AbbVie has led 364 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
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
Eligibility
| Sex | All |
|---|---|
| Ages | 18 Years – 80 Years |
| Healthy volunteers | No |
Eligibility as written in the registry
Eligibility in plain statements
This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.
Study design
| Study type | Interventional |
|---|---|
| Phase | Phase 2 |
| Allocation | Randomised |
| Intervention model | SEQUENTIAL |
| Primary purpose | TREATMENT |
| Masking | QUADRUPLE (4) |
| Enrolment | 200 participants sought |
Sponsor and collaborators
- AbbVie Sponsor
Arms and interventions
- AGN-151607-DP Dose AEXPERIMENTAL
Participants will receive AGN-151607-DP Dose A on Day 1.
- AGN-151607-DP Dose BEXPERIMENTAL
Participants will receive AGN-151607-DP Dose B on Day 1.
- AGN-151607-DP Dose CEXPERIMENTAL
Participants will receive AGN-151607-DP Dose C on Day 1.
- Placebo for AGN-151607-DPPLACEBO_COMPARATOR
Participants will receive Placebo for AGN-151607-DP on Day 1.
Interventions
- Drug AGN-151607-DP
Intramuscular Injection
- Drug Placebo for AGN-151607-DP
Intramuscular Injection
Outcome measures
Primary outcome
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
Primary outcome
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 outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Secondary outcome
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
Dates
| Start date | February 4, 2026 (actual) |
|---|---|
| Primary completion | September 1, 2028 (estimated) |
| Completion | May 1, 2030 (estimated) |
| First posted | November 10, 2025 (actual) |
| Last updated | August 25, 2026 |
| Results posted | Not stated in the registry record |
| Status last verified | August 2026 |
Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.
Locations
11 sites are recruiting
United States
| Facility | City | State or region | Status |
|---|---|---|---|
| Cleveland Clinic - Cleveland /ID# 277914 | Cleveland | Ohio | Recruiting |
| Baylor University Medical Center /ID# 261955 | Dallas | Texas | Recruiting |
| NorthShore University-Endeavor Health Evanston Hospital /ID# 277995 | Evanston | Illinois | Recruiting |
| Prisma Health Greenville Memorial Hospital /ID# 261995 | Greenville | South Carolina | Recruiting |
| Penn State Milton S. Hershey Medical Center /ID# 261987 | Hershey | Pennsylvania | 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 |
| CARI Clinical Trials INC /ID# 278844 | Riverside | California | Recruiting |
| Carilion Roanoke Memorial Hospital /ID# 278577 | Roanoke | Virginia | Recruiting |
| Mayo Clinic Hospital Rochester /ID# 278995 | Rochester | Minnesota | Recruiting |
| Integrity Clinical Research /ID# 278710 | Wichita | Kansas | Completed |
| Novant Health New Hanover Regional Medical Center /ID# 261979 | Wilmington | North Carolina | Recruiting |
Study documents
No documents are linked in this registry record.
Changes over time
- August 25, 2026
Site added
1 site added (13 total)
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