LTG-001 for Postoperative Pain

Recruiting at 4 trial locations

Overseen By Director of Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Latigo Biotherapeutics

Must not be taking: NSAIDs, Benzodiazepines, Opioids, QTc prolongers

Disqualifiers: Hepatic function, Heart disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 48 hours

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new drug, LTG-001, can alleviate pain after "tummy tuck" surgery. The researchers aim to determine the drug's effectiveness in reducing pain over 48 hours and assess its safety. Participants will receive either a high dose, a low dose, or a placebo. Candidates may qualify if they are scheduled for a tummy tuck and have no history of major abdominal surgeries or certain medical conditions. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but it excludes those who have used NSAIDs, benzodiazepines, or opioids in the last year, and those on medications that affect heart rhythms. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LTG-001 has promising safety results from earlier studies. In a study with 72 healthy participants, LTG-001 was well tolerated, with most experiencing no serious side effects. The body absorbed the treatment quickly, indicating potential for effective pain relief. Overall, these findings suggest that LTG-001 is generally safe for humans. However, monitoring for any side effects during the trial is crucial to ensure continued safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for postoperative pain, such as opioids or NSAIDs, LTG-001 offers a novel approach by potentially targeting pain through a unique mechanism. Researchers are particularly excited about the high and low doses of LTG-001 because they may provide effective pain relief with potentially fewer side effects than traditional pain medications. This could be a game-changer in managing postoperative pain, reducing reliance on opioids, and enhancing recovery for patients.

What evidence suggests that LTG-001 might be an effective treatment for postoperative pain?

In earlier studies, LTG-001 has shown promise in managing pain. Research on LTG-001 for pain after dental surgery, such as wisdom tooth removal, showed it effectively reduced pain levels. Participants tolerated the drug well, experiencing no serious side effects. Additionally, LTG-001 is absorbed quickly in the body, providing fast pain relief. These findings suggest that LTG-001 might effectively treat sudden pain after abdominoplasty, a type of tummy tuck surgery. Participants in this trial will receive either a high dose or a low dose of LTG-001, while others will receive a placebo or an active comparator, HB/APAP, to evaluate its effectiveness in postoperative pain management. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing acute pain after an abdominoplasty surgery. Participants will take the study drug twice daily and stay at the clinic for about 48 hours post-surgery, then return after two weeks for a safety follow-up.

Inclusion Criteria

My BMI is between 18.0 and 35.

I am between 18 and 50 years old.

Has signed informed consent and will comply with the requirements and restrictions of the study

Exclusion Criteria

Abnormal liver laboratories or other lab abnormality indicative of serious medical condition

I cannot take medications by mouth.

I haven't used NSAIDs, benzodiazepines, opioids, or QTc-prolonging drugs regularly in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants take LTG-001 bid after the surgical abdominoplasty and remain at the clinic for approximately 48 hours during study dosing

48 hours

Continuous stay at clinic

Follow-up

Participants return after two weeks for a safety check-up and report pain relief during the 48 hours to record changes in post-operative pain

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LTG-001

Trial Overview The study tests LTG-001's effectiveness in managing acute pain following abdominoplasty. It compares low and high doses of LTG-001 against HB/APAP (a known medication) and a placebo to determine which dose works better.

How Is the Trial Designed?

Group I: LTG-001 Low Dose Experimental Treatment 1 Intervention

Group II: LTG-001 High Dose Experimental Treatment 1 Intervention

High Dose LTG-001

Group III: HB/APAP Active Control 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Latigo Biotherapeutics

Lead Sponsor

Trials

4

Recruited

480+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06774625

NCT06774625 | This is a Study Evaluating the Efficacy ... The goal of this clinical trial is to learn if LTG-001 works to treat pain after third molar removal surgery in adults. It will also learn about the safety of ...

2. latigobio.com latigobio.com/latigo-biotherapeutics-announces-positive-phase-1-data-for-lead-non-opioid-pain-medicine-candidate/

Latigo Biotherapeutics Announces Positive Phase 1 Data ... Results from the Phase 1 clinical trial in 72 healthy subjects showed that LTG-001 was well tolerated and demonstrated rapid absorption with a T ...

3. enterprises.upmc.com enterprises.upmc.com/resources/insights/reimagining-relief-fostering-innovation-in-pain-management/

Reimagining Relief: Fostering Innovation in Pain ... In the Phase 1 first-in-human clinical trial, data showed that LTG-001 was well tolerated with rapid absorption.

4. prnewswire.com prnewswire.com/news-releases/latigo-biotherapeutics-announces-positive-phase-1-data-for-lead-non-opioid-pain-medicine-candidate-and-appoints-neil-singla-md-chief-medical-officer-302224151.html

Latigo Biotherapeutics Announces Positive Phase 1 Data ... Results from the Phase 1 clinical trial in 72 healthy subjects showed that LTG-001 was well tolerated and demonstrated rapid absorption with a T ...

5. patlynk.com patlynk.com/trial/NCT07102459

LTG-001 for Acute Pain After Abdominoplasty The study will gather data on both the effectiveness and tolerability of the medication, contributing valuable information for future pain management ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11992992/

A Double-Blind, Sequential Dose-Finding Study - PMC Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesthesia Analg ...