Ventral HerniaPhase 2NCT07226791
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 study testing AGN-151607-DP in people with Ventral Hernia, run by AbbVie at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- AGN-151607-DP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 13 sitesUnited States
- Study dates
- 4 Feb 2026to May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Midline ventral hernia requiring open surgical repair.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 11 recruiting
- Recruiting
Cleveland Clinic - Cleveland /ID# 277914
Cleveland, Ohio, 44195
- Recruiting
Baylor University Medical Center /ID# 261955
Dallas, Texas, 75246
- Recruiting
NorthShore University-Endeavor Health Evanston Hospital /ID# 277995
Evanston, Illinois, 60201
- Recruiting
Prisma Health Greenville Memorial Hospital /ID# 261995
Greenville, South Carolina, 29605-4210
- Recruiting
Penn State Milton S. Hershey Medical Center /ID# 261987
Hershey, Pennsylvania, 17033-2360
- Completed
University of Florida - Jacksonville /ID# 261992
Jacksonville, Florida, 32209
- Recruiting
Medical Research Center /ID# 278680
Miami, Florida, 33144
- Recruiting
Avanza Medical Research Center /ID# 278885
Pensacola, Florida, 32503
- Recruiting
CARI Clinical Trials INC /ID# 278844
Riverside, California, 92504
- Recruiting
Carilion Roanoke Memorial Hospital /ID# 278577
Roanoke, Virginia, 24014
- Recruiting
Mayo Clinic Hospital Rochester /ID# 278995
Rochester, Minnesota, 55905
- Completed
Integrity Clinical Research /ID# 278710
Wichita, Kansas, 67202
- Recruiting
Novant Health New Hanover Regional Medical Center /ID# 261979
Wilmington, North Carolina, 28401-7407
Site Coordinator, 910-465-6679
About this study
Official 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
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.
Read more
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
- Being tested
- AGN-151607-DP, Placebo for AGN-151607-DP
- Keywords
- Ventral Hernia, AGN-151607-DP, Primary fascial closure, Open Abdominal Ventral Hernia Repair
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-151607-DPDrug
Intramuscular Injection
Placebo for AGN-151607-DPDrug
Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| AGN-151607-DP Dose A | Experimental | Participants will receive AGN-151607-DP Dose A on Day 1. Receives: Drug: AGN-151607-DP |
| AGN-151607-DP Dose B | Experimental | Participants will receive AGN-151607-DP Dose B on Day 1. Receives: Drug: AGN-151607-DP |
| AGN-151607-DP Dose C | Experimental | Participants will receive AGN-151607-DP Dose C on Day 1. Receives: Drug: AGN-151607-DP |
| Placebo for AGN-151607-DP | Placebo comparator | Participants will receive Placebo for AGN-151607-DP on Day 1. Receives: Drug: Placebo for AGN-151607-DP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 1 Month
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.
Measured: Up to approximately 25 Months
Secondary outcomes (7)
Percentage of Participants Achieving PFC
PFC will be defined as the ability to achieve fascia to fascia midline approximation.
Measured: Up to approximately 1 Month
Percentage of Participants With Usage of CST for the Purpose of PFC
Percentage of participants with usage of CST will be assessed.
Measured: Up to approximately 1 Month
Number of Lateral Abdominal Wall Muscles Released to Achieve PFC
Number of lateral abdominal wall muscles released to achieve PFC will be assessed.
Measured: Up to approximately 1 Month
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.
Measured: Up to approximately 1 Month
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.
Measured: Up to approximately 1 Month
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.
Measured: Up to approximately 1 Month
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.
Measured: Up to approximately 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start4 Feb 2026
- Primary completionSep 2028 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226791
- Sponsor's protocol ID
- M24-846
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07226791
- Acronym / sponsor ID
- M24-846
- Conditions
- Ventral Hernia
- Keywords
- Ventral Hernia, AGN-151607-DP, Primary fascial closure, Open Abdominal Ventral Hernia Repair
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AGN-151607-DP Dose A | Experimental | Drug: AGN-151607-DPParticipants will receive AGN-151607-DP Dose A on Day 1. |
| AGN-151607-DP Dose B | Experimental | Drug: AGN-151607-DPParticipants will receive AGN-151607-DP Dose B on Day 1. |
| AGN-151607-DP Dose C | Experimental | Drug: AGN-151607-DPParticipants will receive AGN-151607-DP Dose C on Day 1. |
| Placebo for AGN-151607-DP | Placebo comparator | Drug: Placebo for AGN-151607-DPParticipants will receive Placebo for AGN-151607-DP on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Midline ventral hernia requiring open surgical repair.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGN-151607-DPIntramuscular Injection | Drug | AGN-151607-DP Dose A, AGN-151607-DP Dose B, AGN-151607-DP Dose C |
| Placebo for AGN-151607-DPIntramuscular Injection | Drug | Placebo for AGN-151607-DP |
Primary outcome
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.
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.
7 secondary outcomes
Percentage of Participants Achieving PFC
Time frame: Up to approximately 1 Month
Percentage of Participants With Usage of CST for the Purpose of PFC
Time frame: Up to approximately 1 Month
Number of Lateral Abdominal Wall Muscles Released to Achieve PFC
Time frame: Up to approximately 1 Month
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 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 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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: 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.
Related trials for Ventral Hernia
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AGN-151607-DP in people with Ventral Hernia, run by AbbVie at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.