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

NCT ID: NCT06774625

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-19
• Study Completion Date: 2025-08-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LTG-001 High Dose

Group Type: EXPERIMENTAL

LTG-001 High Dose

Intervention Type: DRUG

LTG-001 High Dose

LTG-001 Mid Dose

Group Type: EXPERIMENTAL

LTG-001 Mid Dose

Intervention Type: DRUG

LTG-001 Mid Dose

LTG-001 Low Dose

Group Type: EXPERIMENTAL

LTG-001 Low Dose

Intervention Type: DRUG

LTG-001 Low Dose

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Suzetrigine

Group Type: ACTIVE_COMPARATOR

Suzetrigine

Intervention Type: DRUG

Active comparator - Nav1.8 inhibitor

Interventions

LTG-001 High Dose

LTG-001 High Dose

Intervention Type: DRUG

LTG-001 Mid Dose

LTG-001 Mid Dose

Intervention Type: DRUG

LTG-001 Low Dose

LTG-001 Low Dose

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

Suzetrigine

Active comparator - Nav1.8 inhibitor

Intervention Type: DRUG

Other Intervention Names

LTG-001

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Latigo Biotherapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

JBR Clinical Research

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

LTG-001-003

Identifier Type: -

Identifier Source: org_study_id