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Completed

NCT Number: NCT07102459

An Efficacy and Safety Study of LTG-001 Following Abdominoplasty

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Postoperative Pain Control Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Research Center, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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.

Treatment and study plan

Experimental: LTG-001 High Dose

Drug

High Dose Active

Experimental: LTG-001 Low Dose

Drug

Lower Dose Active

Active Comparator: HB/APAP

Drug

Active Comparator

placebo comparator

Drug

Placebo

Primary outcomes

  1. SPIDr0-48

    Time frame: 48 hours

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

Secondary outcomes

  1. Total Opioid Rescue

    Time frame: 48 hours

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

  2. No Opioid requirement

    Time frame: 48 hours

    Proportion of participants requiring no opioid rescue medication over 48 hours

  3. 2-Point NPRS Reduction

    Time frame: 48 hours

    Time to ≥2-point reduction in NPRS from baseline

  4. 1-Point NPRS Reduction

    Time frame: 48 Hours

    Time to ≥1-point reduction in NPRS from baseline

  5. Nausea and Vomiting

    Time frame: 48 hours

    Incidence of nausea or vomiting

  6. PID at 60 minutes

    Time frame: 1 hour

    Time-specific PID at 60 minutes

  7. SPID r0-24

    Time frame: 24 hours

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

  8. Patient Global Assessment

    Time frame: 48 Hours

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

Sponsors and collaborators

Lead sponsor

Latigo Biotherapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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