An Efficacy and Safety Study of LTG-001 Following Abdominoplasty

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Pain, Postoperative Pain Control

In brief

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.

Key facts

Study ID

NCT07102459

Run by

Latigo Biotherapeutics

People needed

343

Starts

2025-07-24

Expected to finish

2026-01-07

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• CenExel ACMR — Atlanta, Georgia, United States
• HD Research LLC — Houston, Texas, United States
• Endeavor Clinical Research — San Antonio, Texas, United States
• JBR Clinical Research (CenExel) — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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