This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars

Phase 2

Recruiting

• Conditions: Acute Pain, Postoperative
• Interventions: Drug: LTG-001 High Dose; Drug: LTG-001 Mid Dose; Drug: LTG-001 Low Dose; Other: Placebo; Drug: Suzetrigine

• Registration Number: NCT06774625
• Lead Sponsor: Latigo Biotherapeutics

Brief 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 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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-19
• Study First Submitted: 2024-12-23
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-14
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• A subject with sleep apnea and/or on a home continuous positive airway pressure machine.
• Positive drug screen.
• Participant is under legal custodianship.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LTG-001 High Dose	LTG-001 High Dose	-
LTG-001 Mid Dose	LTG-001 Mid Dose	-
LTG-001 Low Dose	LTG-001 Low Dose	-
Placebo	Placebo	-
Suzetrigine	Suzetrigine	-

Primary Outcome Measures

Name	Time	Method
SPID 0-12	12 hours	Pain Intensity NRS Score change over the study.

Secondary Outcome Measures

Name	Time	Method
Perceptible Pain Relief	12 hours	Time to Confirmed Perceptible Pain Relief, assessed via 2-stopwatch technique.
2 Point Reduction in Pain on 0-10 Numerical Rating Scale	12 hours	Time to ≥ 2-point reduction in Numerical Rating Scale from baseline compared to placebo.
Meaningful Pain Relief	12 hours	Time to Meaningful Pain Relief, assessed via 2-stopwatch technique.
Time to Rescue	12 hours	Time to first use of rescue medication.
Global Evaluation	12 hours	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?"
No Required Rescue	12 hours	Subjects requiring no rescue opioid over 12 hours.
Total Rescue	12 hours	Total opioid rescue consumption over 12 hours.
TOTPAR over 0 to 12 hours	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.

Trial Locations

Locations (1)

JBR Clinical Research; 🇺🇸 Salt Lake City, Utah, United States