Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-26 @ 1:23 PM
Study NCT ID:
NCT07102459
Status:
RECRUITING
Last Update Posted:
2025-10-20
First Post:
2025-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy and Safety Study of LTG-001 Following Abdominoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-07-28', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SPIDr0-48', 'timeFrame': '48 hours', 'description': 'Time-weighted SPIDr0-48 after the first dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Total Opioid Rescue', 'timeFrame': '48 hours', 'description': 'Total opioid rescue medication consumption from 0 48 hours, using MMEs'}, {'measure': 'No Opioid requirement', 'timeFrame': '48 hours', 'description': 'Proportion of participants requiring no opioid rescue medication over 48 hours'}, {'measure': 'Nausea and Vomiting', 'timeFrame': '48 hours', 'description': 'Incidence of nausea or vomiting'}, {'measure': '2-Point NPRS Reduction', 'timeFrame': '48 hours', 'description': 'Time to ≥2-point reduction in NPRS from baseline'}, {'measure': '1-Point NPRS Reduction', 'timeFrame': '48 Hours', 'description': 'Time to ≥1-point reduction in NPRS from baseline'}, {'measure': 'PID at 60 minutes', 'timeFrame': '1 hour', 'description': 'Time-specific PID at 60 minutes'}, {'measure': 'SPID r0-24', 'timeFrame': '24 hours', 'description': 'Time-weighted SPIDr0-24 after the first dose of study drug'}, {'measure': 'Patient Global Assessment', 'timeFrame': '48 Hours', 'description': 'Proportion of participants with favorable PGA of study drug at end of treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Pain', 'Abdominoplasty'], 'conditions': ['Acute Pain', 'Postoperative Pain Control']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\nDoes 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?\n\nParticipants will:\n\nTake 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is male or female aged 18 to 50 years\n* Scheduled to undergo an elective "partial" abdominoplasty under general anesthesia\n* Has a body BMI 18.0 to 35 kg/m2\n* Has signed informed consent and will comply with the requirements and restrictions of the study\n* Meet lifestyle, medication, or other study restrictions\n* Subject must agree to study required use of birth control\n* Post-surgical (abdominoplasty) pain must meet the study threshold\n\nExclusion Criteria:\n\n* Inability to take oral medications\n* Prior abdominoplasty or a prior intra-abdominal and/or pelvic surgery (including hysterectomy and Cesarean section) that resulted in any complications\n* History of impaired hepatic function or heart disease.\n* Abnormal liver laboratories or other lab abnormality indicative of serious medical condition\n* Sensory abnormality that would confound post-surgery pain assessments\n* Chronic use of NSAIDs, benzodiazepines, opioid use within the last year, use of medications that prolong QTc intervals, or other dietary and medication restrictions\n* A subject with sleep apnea and/or on a home continuous positive airway pressure machine.\n* Positive drug screen.'}, 'identificationModule': {'nctId': 'NCT07102459', 'briefTitle': 'An Efficacy and Safety Study of LTG-001 Following Abdominoplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Latigo Biotherapeutics'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'LTG-001-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LTG-001 High Dose', 'description': 'High Dose LTG-001', 'interventionNames': ['Drug: Experimental: LTG-001 High Dose']}, {'type': 'EXPERIMENTAL', 'label': 'LTG-001 Low Dose', 'interventionNames': ['Drug: Experimental: LTG-001 Low Dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HB/APAP', 'interventionNames': ['Drug: Active Comparator: HB/APAP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo Comparator']}], 'interventions': [{'name': 'Experimental: LTG-001 High Dose', 'type': 'DRUG', 'description': 'High Dose Active', 'armGroupLabels': ['LTG-001 High Dose']}, {'name': 'Experimental: LTG-001 Low Dose', 'type': 'DRUG', 'description': 'Lower Dose Active', 'armGroupLabels': ['LTG-001 Low Dose']}, {'name': 'Active Comparator: HB/APAP', 'type': 'DRUG', 'description': 'Active Comparator', 'armGroupLabels': ['HB/APAP']}, {'name': 'Placebo Comparator', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Recruitment Team', 'role': 'CONTACT', 'email': 'recruitment@azresearchcenter.com', 'phone': '602-863-6363'}, {'name': 'Louise Taber, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'ACMR Patient Inquiries', 'role': 'CONTACT', 'email': 'acmr.recruitment@cenexel.com', 'phone': '404-881-5800'}, {'name': 'Jessica McCoun, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CenExel ACMR', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '77043', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patient Recruitment', 'role': 'CONTACT', 'email': 'jcarr@ergclinical.com', 'phone': '281-369-5765'}, {'name': "Dominick D'Aunno, MD", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HD Research LLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patient Recruitment', 'role': 'CONTACT', 'email': 'RecruitmentECT@ergclinical.com', 'phone': '210-949-0807'}, {'name': 'Emanuel DeNoia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Endeavor Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'JBR Patient Inquiries', 'role': 'CONTACT', 'email': 'participate@jbrutah.com', 'phone': '801-261-2000', 'phoneExt': '483'}, {'name': 'Todd Bertoch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'JBR Clinical Research (CenExel)', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Director of Clinical Operations', 'role': 'CONTACT', 'email': 'msonnemann@latigobio.com', 'phone': '813-486-8342'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Latigo Biotherapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}