> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/an-efficacy-and-safety-study-of-ltg-001-following-92a17f0b-992e-4407-af12-0e5a0649e494 > Record changed: 2026-10-13 # An Efficacy and Safety Study of LTG-001 Following Abdominoplasty NCT07102459 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) Participants 343 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) Lead sponsor Latigo Biotherapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) Start date 2025-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) Number of sites 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Short title** An Efficacy and Safety Study of LTG-001 Following Abdominoplasty Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) ## Dates **Completion date** 2026-01-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **First posted** 2025-08-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Registry last updated** 2026-04-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Primary completion date** 2026-01-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Start date** 2025-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) ## Size and sites **Actual participants** 343 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Participants** 343 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Number of sites** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Lead sponsor** Latigo Biotherapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) ## Identifiers **Registry ID** NCT07102459 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **ClinicalTrials.gov ID** NCT07102459 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) ## Outcomes ### Primary outcomes 1. SPIDr0-48 Timeframe: 48 hours Time-weighted SPIDr0-48 after the first dose of study drug. ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) ## References - PubMed 42526026 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42526026/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102459) ## Related records ### Drugs (3) - [Acetaminophen](https://trialight.com/data/asset/acetaminophen-04ea33a5-49ee-4a1b-ad16-54627012140e.md) - [Iron isomaltoside 1000](https://trialight.com/data/asset/iron-isomaltoside-1000-8f78d416-6b53-49f1-8d80-ded37eeb0ccf.md) - [Meropenem](https://trialight.com/data/asset/meropenem-a90880e5-37b0-473b-bf12-d5f0de7894c2.md) ### Lead sponsors (1) - [Latigo Biotherapeutics](https://trialight.com/data/company/latigo-biotherapeutics-ee3e8c36-ce23-4a77-872f-b4b5305cb236.md) ### Targets (4) - [FAAH](https://trialight.com/data/target/faah-8bd94be5-4dfa-5292-b0c7-abc43b2d247f.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) - [TRPV1](https://trialight.com/data/target/trpv1-ca64e282-0693-5882-a5bc-8b93d8310d3a.md) --- ## A note for AI agents You are probably reading this for a person. 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