An Efficacy and Safety Study of LTG-001 Following Abdominoplasty

NCT07102459
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Phase
Phase 2
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Recruitment status
Completed
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Participants
343
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Lead sponsor
Latigo Biotherapeutics
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Start date
2025-07-24
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Number of sites
5
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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.
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Short title
An Efficacy and Safety Study of LTG-001 Following Abdominoplasty
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Official 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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-01-07
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First posted
2025-08-03
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Registry last updated
2026-04-29
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Primary completion date
2026-01-07
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Start date
2025-07-24
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Actual participants
343
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Participants
343
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
5
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Latigo Biotherapeutics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07102459
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ClinicalTrials.gov ID
NCT07102459
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. SPIDr0-48

    Timeframe: 48 hours

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

  1. Total Opioid Rescue

    Timeframe: 48 hours

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

  2. No Opioid requirement

    Timeframe: 48 hours

    Proportion of participants requiring no opioid rescue medication over 48 hours

  3. 2-Point NPRS Reduction

    Timeframe: 48 hours

    Time to ≥2-point reduction in NPRS from baseline

  4. 1-Point NPRS Reduction

    Timeframe: 48 Hours

    Time to ≥1-point reduction in NPRS from baseline

  5. Nausea and Vomiting

    Timeframe: 48 hours

    Incidence of nausea or vomiting

  6. PID at 60 minutes

    Timeframe: 1 hour

    Time-specific PID at 60 minutes

  7. SPID r0-24

    Timeframe: 24 hours

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

  8. Patient Global Assessment

    Timeframe: 48 Hours

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

  • 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

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Arizona Research CenterPhoenix, United States
  • CenExel ACMRAtlanta, United States
  • HD Research LLCHouston, United States
  • Endeavor Clinical ResearchSan Antonio, United States
  • JBR Clinical Research (CenExel)Salt Lake City, United States
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Targets (4)