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

NCT06774625 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: LTG-001-003
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Pain, Postoperative

Keywords

Acute Pain; Surgical Removal of Impacted Third Molars; Wisdom teeth

Outcome Measures

Primary Outcomes (1)

• SPID 0-12

  Pain Intensity NRS Score change over the study.

  12 hours

Secondary Outcomes (8)

• Perceptible Pain Relief

  12 hours

• Meaningful Pain Relief

  12 hours

• Time to Rescue

  12 hours

• TOTPAR over 0 to 12 hours

  12 hours

• 2 Point Reduction in Pain on 0-10 Numerical Rating Scale

  12 hours

Study Arms (5)

LTG-001 High Dose

EXPERIMENTAL

Drug: LTG-001 High Dose

LTG-001 Mid Dose

EXPERIMENTAL

Drug: LTG-001 Mid Dose

LTG-001 Low Dose

EXPERIMENTAL

Drug: LTG-001 Low Dose

Placebo

PLACEBO COMPARATOR

Other: Placebo

Suzetrigine

ACTIVE COMPARATOR

Drug: Suzetrigine

Interventions

LTG-001 High Dose DRUG

LTG-001 High Dose

Also known as: LTG-001

LTG-001 High Dose

LTG-001 Mid Dose DRUG

LTG-001 Mid Dose

LTG-001 Mid Dose

LTG-001 Low Dose DRUG

LTG-001 Low Dose

LTG-001 Low Dose

Placebo OTHER

Placebo

Placebo

Suzetrigine DRUG

Active comparator - Nav1.8 inhibitor

Suzetrigine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Latigo Biotherapeutics: lead

Study Sites (1)

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 14, 2025
• Study Start: December 19, 2024
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)