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, 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?

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 Overview

• Status: Completed
• Conditions: Acute Pain, Postoperative
• Intervention / Treatment: Other: Placebo; Drug: LTG-001 High Dose; Drug: LTG-001 Mid Dose; Drug: LTG-001 Low Dose; Drug: Suzetrigine

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • JBR Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Experimental: LTG-001 High Dose; High Dose	Drug: LTG-001 High Dose; LTG-001 High Dose; Other Names: LTG-001
Experimental: LTG-001 Mid Dose; Medium Dose	Drug: LTG-001 Mid Dose; LTG-001 Mid Dose
Experimental: LTG-001 Low Dose; Low Dose	Drug: LTG-001 Low Dose; LTG-001 Low Dose
Active Comparator: Suzetrigine; Comparator	Drug: Suzetrigine; Active comparator - Nav1.8 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPID 0-12	Pain Intensity NRS Score change over the study.	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceptible Pain Relief	Time to Confirmed Perceptible Pain Relief, assessed via 2-stopwatch technique.	12 hours
Meaningful Pain Relief	Time to Meaningful Pain Relief, assessed via 2-stopwatch technique.	12 hours
Time to Rescue	Time to first use of rescue medication.	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.	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.	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?"	12 hours
No Required Rescue	Subjects requiring no rescue opioid over 12 hours.	12 hours
Total Rescue	Total opioid rescue consumption over 12 hours.	12 hours

Collaborators and Investigators

• Sponsor: Latigo Biotherapeutics

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Actual): August 8, 2025
• Study Completion (Actual): August 8, 2025

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): January 14, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Acute Pain; Surgical Removal of Impacted Third Molars; Wisdom teeth
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: LTG-001-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No