Recruiting

LTG-001 for Acute Pain After Abdominoplasty

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What is being tested

Experimental: LTG-001 High Dose

+ Experimental: LTG-001 Low Dose

+ Active Comparator: HB/APAP

Drug
Who is being recruted

Neurologic Manifestations+2

+ Pain

+ Signs and Symptoms

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorLatigo Biotherapeutics
Study ContactDirector of Clinical Operations
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: July 24, 2025

Actual date on which the first participant was enrolled.

This clinical trial is designed to find out if a medication called LTG-001 can effectively manage pain after undergoing an abdominoplasty, commonly known as a tummy tuck. The study focuses on people who have just had this type of surgery and aims to understand how well the drug can control pain within the first 48 hours after the operation. It also seeks to determine the most effective dose of LTG-001 and assess its safety during this period. This study is important because managing pain effectively after surgery can significantly improve recovery and comfort for patients. Participants in this study will take the medication LTG-001 twice a day after their abdominoplasty. They will stay in the clinic for about 48 hours while the medication is administered, allowing researchers to closely monitor their response to the treatment. After two weeks, participants will return for a safety check-up. During the initial 48-hour period, they will report any changes in their pain levels, helping to evaluate how well LTG-001 alleviates post-operative pain. The study will gather data on both the effectiveness and tolerability of the medication, contributing valuable information for future pain management strategies.

Official TitleA Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After an Abdominoplasty 
NCT07102459
Principal SponsorLatigo Biotherapeutics
Study ContactDirector of Clinical Operations
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

360 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsAcute Pain

Criteria

Inclusion Criteria: * Subject is male or female aged 18 to 50 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 Exclusion Criteria: * 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
High Dose LTG-001

Group II

Experimental

Group III

Active Comparator

Group IV

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Recruiting

Arizona Research Center

Phoenix, United StatesSee the location
Recruiting

CenExel ACMR

Atlanta, United States
Recruiting

HD Research LLC

Houston, United States
Recruiting

Endeavor Clinical Research

San Antonio, United States
Recruiting
5 Study Centers