An Efficacy and Safety Study of LTG-001 Following Abdominoplasty

Latigo Biotherapeutics

Status and phase: Enrolling; Phase 2

Conditions: Acute Pain; Postoperative Pain Control

Treatments: Drug: Experimental: LTG-001 Low Dose; Drug: Placebo Comparator; Drug: Experimental: LTG-001 High Dose; Drug: Active Comparator: HB/APAP

Study type: Interventional

Funder types: Industry

Identifiers

NCT07102459

LTG-001-010

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 4 patient groups, including a placebo group

LTG-001 High Dose

Experimental group

Description:

High Dose LTG-001

Treatment:

Drug: Experimental: LTG-001 High Dose

LTG-001 Low Dose

Experimental group

Treatment:

Drug: Experimental: LTG-001 Low Dose

HB/APAP

Active Comparator group

Treatment:

Drug: Active Comparator: HB/APAP

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo Comparator