Acute PainPhase 2NCT07102459
An Efficacy and Safety Study of LTG-001 Following Abdominoplasty
A Phase 2 study testing Experimental: LTG-001 High Dose, Experimental: LTG-001 Low Dose and Active Comparator: HB/APAP in people with Acute Pain and Postoperative Pain Control, run by Latigo Biotherapeutics at 5 sites in United States.
Trial summary
The goal of this clinical trial is to learn if LTG-001 works to treat post-operative / acute pain after an abdominoplasty procedure. It will also learn more information on the safety of LTG-001. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Pain, Postoperative Pain Control
- What is being tested?
- Experimental: LTG-001 High Dose, Experimental: LTG-001 Low Dose and Active Comparator: HB/APAP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 343 participants
- Where
- 5 sitesUnited States
- Study dates
- 24 Jul 2025to 7 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male or female aged 18 to 65 years
- Scheduled to undergo an elective "partial" abdominoplasty under general anesthesia
- Has a body BMI 18.0 to 35 kg/m2
- Has signed informed consent and will comply with the requirements and restrictions of the study
- Meet lifestyle, medication, or other study restrictions
- Subject must agree to study required use of birth control
- Post-surgical (abdominoplasty) pain must meet the study threshold
Who cannot join
- Inability to take oral medications
- Prior abdominoplasty or a prior intra-abdominal and/or pelvic surgery (including hysterectomy and Cesarean section) that resulted in any complications
- History of impaired hepatic function or heart disease.
- Abnormal liver laboratories or other lab abnormality indicative of serious medical condition
- Sensory abnormality that would confound post-surgery pain assessments
- Chronic use of NSAIDs, benzodiazepines, opioid use within the last year, use of medications that prolong QTc intervals, or other dietary and medication restrictions
- A subject with sleep apnea and/or on a home continuous positive airway pressure machine.
- Positive drug screen.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
CenExel ACMR
Atlanta, Georgia, 30331
HD Research LLC
Houston, Texas, 77043
Arizona Research Center
Phoenix, Arizona, 85053
JBR Clinical Research (CenExel)
Salt Lake City, Utah, 84107
Endeavor Clinical Research
San Antonio, Texas, 78240
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After an Abdominoplasty
The goal of this clinical trial is to learn if LTG-001 works to treat post-operative / acute pain after an abdominoplasty procedure. It will also learn more information on the safety of LTG-001.
The main questions it aims to answer are:
Read more
Does drug LTG-001 treat the acute pain after surgical abdominoplasty over 48 hours? How tolerable is LTG-001 over 48 hours? What dose of LTG-001 is better for treating post-operative / acute pain?
Participants will:
Take LTG-001 bid after the surgical abdominoplasty. Remain at the clinic for approximately 48 hours during study dosing and return after two weeks for a safety check up. Report the pain relief during the 48 hours to record changes in the post-operative pain.
- Conditions
- Acute Pain, Postoperative Pain Control
- Being tested
- Experimental: LTG-001 High Dose, Experimental: LTG-001 Low Dose, Active Comparator: HB/APAP, Placebo Comparator
- Keywords
- Acute Pain, Abdominoplasty
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: LTG-001 High DoseDrug
High Dose Active
Experimental: LTG-001 Low DoseDrug
Lower Dose Active
Active Comparator: HB/APAPDrug
Active Comparator
Placebo ComparatorDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| LTG-001 High Dose | Experimental | High Dose LTG-001 Receives: Drug: Experimental: LTG-001 High Dose |
| LTG-001 Low Dose | Experimental | Not described Receives: Drug: Experimental: LTG-001 Low Dose |
| HB/APAP | Active comparator | Not described Receives: Drug: Active Comparator: HB/APAP |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPIDr0-48
Time-weighted SPIDr0-48 after the first dose of study drug.
Measured: 48 hours
Secondary outcomes (8)
Total Opioid Rescue
Total opioid rescue medication consumption from 0 48 hours, using MMEs
Measured: 48 hours
No Opioid requirement
Proportion of participants requiring no opioid rescue medication over 48 hours
Measured: 48 hours
2-Point NPRS Reduction
Time to ≥2-point reduction in NPRS from baseline
Measured: 48 hours
1-Point NPRS Reduction
Time to ≥1-point reduction in NPRS from baseline
Measured: 48 Hours
Nausea and Vomiting
Incidence of nausea or vomiting
Measured: 48 hours
PID at 60 minutes
Time-specific PID at 60 minutes
Measured: 1 hour
SPID r0-24
Time-weighted SPIDr0-24 after the first dose of study drug
Measured: 24 hours
Patient Global Assessment
Proportion of participants with favorable PGA of study drug at end of treatment
Measured: 48 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start24 Jul 2025
- Primary completion7 Jan 2026
- Study completion7 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latigo Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102459
- Sponsor's protocol ID
- LTG-001-010
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singla N, Katz NP, Vaughn B, Rogier T, Bertoch T, Minkowitz H, Loflin M. Phase 2b Trial of a NaV1.8 Inhibitor for Acute Pain. N Engl J Med. 2026 Jul 30;395(5):454-464. doi: 10.1056/NEJMoa2602910.
PubMed 42526026
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After an Abdominoplasty
- ClinicalTrials.gov ID
- NCT07102459
- Acronym / sponsor ID
- LTG-001-010
- Conditions
- Acute Pain, Postoperative Pain Control
- Keywords
- Acute Pain, Abdominoplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Latigo BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 3 Aug 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.
The goal of this clinical trial is to learn if LTG-001 works to treat post-operative / acute pain after an abdominoplasty procedure. It will also learn more information on the safety of LTG-001.
The main questions it aims to answer are:
Does drug LTG-001 treat the acute pain after surgical abdominoplasty over 48 hours? How tolerable is LTG-001 over 48 hours? What dose of LTG-001 is better for treating post-operative / acute pain?
Participants will:
Take LTG-001 bid after the surgical abdominoplasty. Remain at the clinic for approximately 48 hours during study dosing and return after two weeks for a safety check up. Report the pain relief during the 48 hours to record changes in the post-operative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LTG-001 High Dose | Experimental | Drug: Experimental: LTG-001 High DoseHigh Dose LTG-001 |
| LTG-001 Low Dose | Experimental | Drug: Experimental: LTG-001 Low Dose |
| HB/APAP | Active comparator | Drug: Active Comparator: HB/APAP |
| Placebo | Placebo comparator | Drug: Placebo Comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is male or female aged 18 to 65 years
- Scheduled to undergo an elective "partial" abdominoplasty under general anesthesia
- Has a body BMI 18.0 to 35 kg/m2
- Has signed informed consent and will comply with the requirements and restrictions of the study
- Meet lifestyle, medication, or other study restrictions
Key exclusion criteria (8 listed)
- Inability to take oral medications
- Prior abdominoplasty or a prior intra-abdominal and/or pelvic surgery (including hysterectomy and Cesarean section) that resulted in any complications
- History of impaired hepatic function or heart disease.
- Abnormal liver laboratories or other lab abnormality indicative of serious medical condition
- Sensory abnormality that would confound post-surgery pain assessments
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 |
|---|---|---|
| Experimental: LTG-001 High DoseHigh Dose Active | Drug | LTG-001 High Dose |
| Experimental: LTG-001 Low DoseLower Dose Active | Drug | LTG-001 Low Dose |
| Active Comparator: HB/APAPActive Comparator | Drug | HB/APAP |
| Placebo ComparatorPlacebo | Drug | Placebo |
Primary outcome
SPIDr0-48
Time frame: 48 hours
Time-weighted SPIDr0-48 after the first dose of study drug.
8 secondary outcomes
Total Opioid Rescue
Time frame: 48 hours
No Opioid requirement
Time frame: 48 hours
2-Point NPRS Reduction
Time frame: 48 hours
1-Point NPRS Reduction
Time frame: 48 Hours
Nausea and Vomiting
Time frame: 48 hours
PID at 60 minutes
Time frame: 1 hour
SPID r0-24
Time frame: 24 hours
Patient Global Assessment
Time frame: 48 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 42526026Singla N, Katz NP, Vaughn B, Rogier T, Bertoch T, Minkowitz H, Loflin M. Phase 2b Trial of a NaV1.8 Inhibitor for Acute Pain. N Engl J Med. 2026 Jul 30;395(5):454-464. doi: 10.1056/NEJMoa2602910.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 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 Experimental: LTG-001 High Dose, Experimental: LTG-001 Low Dose and Active Comparator: HB/APAP in people with Acute Pain and Postoperative Pain Control, run by Latigo Biotherapeutics at 5 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPIDr0-48 (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07102459, which also lists 1 linked publication.
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 29 Apr 2026.