This is a Study Evaluating the Efficacy and Safety of LTG... | NCT06774625

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 19, 2024Actual

Primary Completion Date

Aug 8, 2025Actual

Completion Date

Aug 8, 2025Actual

First Submitted Date

Dec 23, 2024

First Submission Date that Met QC Criteria

Jan 8, 2025

First Posted Date

Jan 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

May 15, 2026

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Jan 9, 2026Actual

Last Update Submitted Date

May 20, 2026

Last Update Posted Date

May 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LTG-001 High Dose	Experimental	High Dose	Drug: LTG-001 High Dose
LTG-001 Mid Dose	Experimental	Medium Dose	Drug: LTG-001 Mid Dose
LTG-001 Low Dose	Experimental	Low Dose	Drug: LTG-001 Low Dose
Placebo	Placebo Comparator	Placebo	Other: Placebo
Suzetrigine	Active Comparator	Comparator	Drug: Suzetrigine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LTG-001 High Dose	Drug	LTG-001 High Dose	LTG-001 High Dose	LTG-001

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
JBR Clinical Research		Salt Lake City	Utah	84107	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D010149	Pain, Postoperative
D059787	Acute Pain

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms