NCT07102459

An Efficacy and Safety Study of LTG-001 Following Abdominoplasty

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After an Abdominoplasty

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Latigo Biotherapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pain
• Postoperative Pain Control

Interventions

Type	Name	Description
DRUG	Experimental: LTG-001 High Dose	High Dose Active
DRUG	Experimental: LTG-001 Low Dose	Lower Dose Active
DRUG	Active Comparator: HB/APAP	Active Comparator
DRUG	Placebo Comparator	Placebo

Timeline

• Start date: 2025-07-24
• Primary completion: 2026-01-07
• Completion: 2026-01-07
• First posted: 2025-08-03
• Last updated: 2026-04-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study