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

Acute Pain

+ Postoperative Pain Control
From 18 to 65 Years
+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 2
Interventional
Study Start: July 2025

See protocol details

Summary

Principal SponsorLatigo Biotherapeutics
Study ContactDirector of Clinical Operations
Last updated: October 20, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 24, 2025Actual 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 
Principal SponsorLatigo Biotherapeutics
Study ContactDirector of Clinical Operations
Last updated: October 20, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Acute Pain
Postoperative Pain Control
Criteria
7 inclusion criteria required to participate
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

Show More Criteria

8 exclusion criteria prevent from participating
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

Show More Criteria

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

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

Total opioid rescue medication consumption from 0 48 hours, using MMEs

Proportion of participants requiring no opioid rescue medication over 48 hours

Incidence of nausea or vomiting

Time to ≥2-point reduction in NPRS from baseline

Time to ≥1-point reduction in NPRS from baseline

Time-specific PID at 60 minutes

Time-weighted SPIDr0-24 after the first dose of study drug

Proportion of participants with favorable PGA of study drug at end of treatment

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 CenterPhoenix, United StatesSee the location
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CenExel ACMRAtlanta, United States
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HD Research LLCHouston, United States
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Endeavor Clinical ResearchSan Antonio, United States
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5 Study Centers