Acute Pain, PostoperativePhase 2NCT06774625
This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars
A Phase 2 study testing LTG-001 High Dose, LTG-001 Mid Dose and LTG-001 Low Dose in people with Acute Pain, Postoperative, run by Latigo Biotherapeutics at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if LTG-001 works to treat pain after third molar removal surgery in adults. It will also learn about the safety of LTG-001. The main questions it aims to answer are: Does drug LTG-001 treat the acute pain after surgical removal of impacted third molars (wisdom teeth) over 12… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Pain, Postoperative
- What is being tested?
- LTG-001 High Dose, LTG-001 Mid Dose and LTG-001 Low Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2024to 8 Aug 2025
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject is male or female aged 18 to 50 years, inclusive, at the time of signing the informed consent
- Has a body weight ≥ 45 kg and a BMI ≤ 35 kg/m2.
- Subject requires extraction of 2 or more third molars, two of which must be mandibular molars that must be fully or partially bony, or combination of one fully and one partially bony impaction.
- Subject must agree to study required use of birth control.
- Post-surgical pain must meet protocol requirements.
Who cannot join
- Inability to take oral medications
- Prior dental surgery within 60 days or other surgical history that could confound surgery or post-operative procedures.
- 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.
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- A subject with sleep apnea and/or on a home continuous positive airway pressure machine.
- Positive drug screen.
- Participant is under legal custodianship.
Trial locations and contacts
1 site in 1 country.
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 Surgical Removal of Impacted Third Molars
The goal of this clinical trial is to learn if LTG-001 works to treat pain after third molar removal surgery in adults. It will also learn about the safety of LTG-001. The main questions it aims to answer are:
Does drug LTG-001 treat the acute pain after surgical removal of impacted third molars (wisdom teeth) over 12 hours? How tolerable is LTG-001 after surgical removal of impacted third molars (wisdom teeth) over 12 hours?
Read more
Researchers in Part 1 will compare drug LTG-001 to a placebo (a look-alike substance that contains no drug) and in Part 2 to a placebo and a comparator to see if drug LTG-001 treats the post-surgical pain.
Participants will:
Take LTG-001 one time after the surgical removal of impacted third molars. Remain at the clinic for 12 hours after study dosing and return after a week for a safety check up.
Report the pain relief during the 12 hours after dosing to record changes in the post-operative pain
- Conditions
- Acute Pain, Postoperative
- Being tested
- LTG-001 High Dose, LTG-001 Mid Dose, LTG-001 Low Dose, Placebo, Suzetrigine
- Keywords
- Acute Pain, Surgical Removal of Impacted Third Molars, Wisdom teeth
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTG-001 High DoseDrug
Also called LTG-001
LTG-001 High Dose
LTG-001 Mid DoseDrug
LTG-001 Mid Dose
LTG-001 Low DoseDrug
LTG-001 Low Dose
PlaceboOther
Placebo
SuzetrigineDrug
Active comparator - Nav1.8 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| LTG-001 High Dose | Experimental | High Dose Receives: Drug: LTG-001 High Dose |
| LTG-001 Mid Dose | Experimental | Medium Dose Receives: Drug: LTG-001 Mid Dose |
| LTG-001 Low Dose | Experimental | Low Dose Receives: Drug: LTG-001 Low Dose |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
| Suzetrigine | Active comparator | Comparator Receives: Drug: Suzetrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID 0-12
Pain Intensity NRS Score change over the study.
Measured: 12 hours
Secondary outcomes (8)
Perceptible Pain Relief
Time to Confirmed Perceptible Pain Relief, assessed via 2-stopwatch technique.
Measured: 12 hours
Meaningful Pain Relief
Time to Meaningful Pain Relief, assessed via 2-stopwatch technique.
Measured: 12 hours
Time to Rescue
Time to first use of rescue medication.
Measured: 12 hours
TOTPAR over 0 to 12 hours
Time-weighted summed pain relief as recorded on a sum of total pain relief (TOTPAR) over 0 to 12 hours (TOTPAR12) after the first dose of study drug.
Measured: 12 hours
2 Point Reduction in Pain on 0-10 Numerical Rating Scale
Time to ≥ 2-point reduction in Numerical Rating Scale from baseline compared to placebo.
Measured: 12 hours
Global Evaluation
Subject's global evaluation based on a 5-point scale asking, "Overall, how effective do you think the study drug is as a treatment for pain?"
Measured: 12 hours
No Required Rescue
Subjects requiring no rescue opioid over 12 hours.
Measured: 12 hours
Total Rescue
Total opioid rescue consumption over 12 hours.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start19 Dec 2024
- Primary completion8 Aug 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pain, PostoperativeStudies 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
- 250 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
- NCT06774625
- Sponsor's protocol ID
- LTG-001-003
- Status last verified
- May 2026
- First submitted
- 23 Dec 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 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 Surgical Removal of Impacted Third Molars
- ClinicalTrials.gov ID
- NCT06774625
- Acronym / sponsor ID
- LTG-001-003
- Conditions
- Acute Pain, Postoperative
- Keywords
- Acute Pain, Surgical Removal of Impacted Third Molars, Wisdom teeth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Latigo BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 14 Jan 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 pain after third molar removal surgery in adults. It will also learn about the safety of LTG-001. The main questions it aims to answer are:
Does drug LTG-001 treat the acute pain after surgical removal of impacted third molars (wisdom teeth) over 12 hours? How tolerable is LTG-001 after surgical removal of impacted third molars (wisdom teeth) over 12 hours?
Researchers in Part 1 will compare drug LTG-001 to a placebo (a look-alike substance that contains no drug) and in Part 2 to a placebo and a comparator to see if drug LTG-001 treats the post-surgical pain.
Participants will:
Take LTG-001 one time after the surgical removal of impacted third molars. Remain at the clinic for 12 hours after study dosing and return after a week for a safety check up.
Report the pain relief during the 12 hours after dosing 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
- 5
| Arm | Type | Receives |
|---|---|---|
| LTG-001 High Dose | Experimental | Drug: LTG-001 High DoseHigh Dose |
| LTG-001 Mid Dose | Experimental | Drug: LTG-001 Mid DoseMedium Dose |
| LTG-001 Low Dose | Experimental | Drug: LTG-001 Low DoseLow Dose |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
| Suzetrigine | Active comparator | Drug: SuzetrigineComparator |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is male or female aged 18 to 50 years, inclusive, at the time of signing the informed consent
- Has a body weight ≥ 45 kg and a BMI ≤ 35 kg/m2.
- Subject requires extraction of 2 or more third molars, two of which must be mandibular molars that must be fully or partially bony, or combination of one fully and one partially bony impaction.
- Subject must agree to study required use of birth control.
- Post-surgical pain must meet protocol requirements.
Key exclusion criteria (9 listed)
- Inability to take oral medications
- Prior dental surgery within 60 days or other surgical history that could confound surgery or post-operative procedures.
- 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 |
|---|---|---|
| LTG-001 High DoseAlso: LTG-001LTG-001 High Dose | Drug | LTG-001 High Dose |
| LTG-001 Mid DoseLTG-001 Mid Dose | Drug | LTG-001 Mid Dose |
| LTG-001 Low DoseLTG-001 Low Dose | Drug | LTG-001 Low Dose |
| PlaceboPlacebo | Other | Placebo |
| SuzetrigineActive comparator - Nav1.8 inhibitor | Drug | Suzetrigine |
Primary outcome
SPID 0-12
Time frame: 12 hours
Pain Intensity NRS Score change over the study.
8 secondary outcomes
Perceptible Pain Relief
Time frame: 12 hours
Meaningful Pain Relief
Time frame: 12 hours
Time to Rescue
Time frame: 12 hours
TOTPAR over 0 to 12 hours
Time frame: 12 hours
2 Point Reduction in Pain on 0-10 Numerical Rating Scale
Time frame: 12 hours
Global Evaluation
Time frame: 12 hours
No Required Rescue
Time frame: 12 hours
Total Rescue
Time frame: 12 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 22 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LTG-001 High Dose, LTG-001 Mid Dose and LTG-001 Low Dose in people with Acute Pain, Postoperative, run by Latigo Biotherapeutics at 1 site 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 5 inclusion and 9 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
SPID 0-12 (time frame: 12 hours). 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 22 May 2026.