NCT07102459

Brief Summary

The goal of this clinical trial is to learn if LTG-001 works to treat post-operative / acute pain after an abdominoplasty procedure. It will also learn more information on the safety of LTG-001. The main questions it aims to answer are: Does drug LTG-001 treat the acute pain after surgical abdominoplasty over 48 hours? How tolerable is LTG-001 over 48 hours? What dose of LTG-001 is better for treating post-operative / acute pain? Participants will: Take LTG-001 bid after the surgical abdominoplasty. Remain at the clinic for approximately 48 hours during study dosing and return after two weeks for a safety check up. Report the pain relief during the 48 hours to record changes in the post-operative pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
343

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2026

Completed
Last Updated

April 29, 2026

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 28, 2025

Last Update Submit

April 28, 2026

Conditions

Acute PainPostoperative Pain Control

Keywords

Acute PainAbdominoplasty

Outcome Measures

Primary Outcomes (1)

  • SPIDr0-48

    Time-weighted SPIDr0-48 after the first dose of study drug.

    48 hours

Secondary Outcomes (8)

  • Total Opioid Rescue

    48 hours

  • No Opioid requirement

    48 hours

  • 2-Point NPRS Reduction

    48 hours

  • 1-Point NPRS Reduction

    48 Hours

  • Nausea and Vomiting

    48 hours

  • +3 more secondary outcomes

Study Arms (4)

LTG-001 High Dose

EXPERIMENTAL

High Dose LTG-001

Drug: Experimental: LTG-001 High Dose

LTG-001 Low Dose

EXPERIMENTAL
Drug: Experimental: LTG-001 Low Dose

HB/APAP

ACTIVE COMPARATOR
Drug: Active Comparator: HB/APAP

Placebo

PLACEBO COMPARATOR
Drug: Placebo Comparator

Interventions

Experimental: LTG-001 High DoseDRUG

High Dose Active

LTG-001 High Dose
Experimental: LTG-001 Low DoseDRUG

Lower Dose Active

LTG-001 Low Dose
Active Comparator: HB/APAPDRUG

Active Comparator

HB/APAP
Placebo ComparatorDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is male or female aged 18 to 65 years
  • Scheduled to undergo an elective "partial" abdominoplasty under general anesthesia
  • Has a body BMI 18.0 to 35 kg/m2
  • Has signed informed consent and will comply with the requirements and restrictions of the study
  • Meet lifestyle, medication, or other study restrictions
  • Subject must agree to study required use of birth control
  • Post-surgical (abdominoplasty) pain must meet the study threshold

You may not qualify if:

  • Inability to take oral medications
  • Prior abdominoplasty or a prior intra-abdominal and/or pelvic surgery (including hysterectomy and Cesarean section) that resulted in any complications
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

CenExel ACMR

Atlanta, Georgia, 30331, United States

Location

HD Research LLC

Houston, Texas, 77043, United States

Location

Endeavor Clinical Research

San Antonio, Texas, 78240, United States

Location

JBR Clinical Research (CenExel)

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, 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

July 28, 2025

First Posted

August 3, 2025

Study Start

July 24, 2025

Primary Completion

January 7, 2026

Study Completion

January 7, 2026

Last Updated

April 29, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(5)