Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT07035093
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729679', 'term': 'retatrutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 586}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2025-06-16', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Pain Intensity Per Numeric Rating Scale', 'timeFrame': 'Baseline, up to 72 weeks'}, {'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Baseline, up to 72 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Reduction in Pain Intensity Per Numeric Rating Scale', 'timeFrame': 'Baseline, up to 72 weeks'}, {'measure': 'Number of Participants with Reduction in Body Weight', 'timeFrame': 'Baseline, up to 72 weeks'}, {'measure': 'Change in Physical Function as Measured by Patient-Reported Outcomes Measurement Information Systems (PROMIS)', 'timeFrame': 'Baseline, up to 72 weeks'}, {'measure': 'Change in Pain Interference as Measured by PROMIS', 'timeFrame': 'Baseline, up to 72 weeks'}, {'measure': 'Change in Sleep as Measured by PROMIS', 'timeFrame': 'Baseline, up to 72 weeks'}, {'measure': 'Change in Patient Reported Health Outcomes as Measured by Medical Outcomes Study 36-item Short Form Health Survey version 2 (SF-36v2)', 'timeFrame': 'Baseline, up to 72 weeks'}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'Baseline, up to 72 weeks'}, {'measure': 'Change in Biomarkers of Inflammation as Measured by Blood Test', 'timeFrame': 'Baseline, up to 72 weeks'}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'Baseline, up to 72 weeks'}, {'measure': 'Change in Glycemic Control', 'timeFrame': 'Baseline, up to 72 weeks'}, {'measure': 'Percent Change in Total Cholesterol', 'timeFrame': 'Baseline, up to 72 weeks'}, {'measure': 'Percent Change in Urine Albumin-to-Creatinine Ratio (UACR)', 'timeFrame': 'Baseline, up to 72 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Axial Predominant Low Back Pain'], 'conditions': ['Obesity', 'Overweight', 'Chronic Low Back Pain (CLBP)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/620575', 'label': 'A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain (TRIUMPH-7)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the efficacy and safety of retatrutide in relieving chronic low back pain in participants who have obesity or overweight. Participation in the study will last about 80 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a history of axial-predominant low back pain\n* Have pain that is restricted to the low back or with a referral pattern limited to the proximal legs\n* Have a body mass index (BMI) ≥27 kilograms per square meter (kg/m2) at screening\n* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight\n\nExclusion Criteria:\n\n* Have a non-axial origin low back pain\n* Have had botulinum or steroid injections to the spine within 1 year of screening\n* Have had trigger point injection to the spine within 6 months of screening\n* Have a self-reported change in body weight \\>5 kilograms (kg) (11 pounds) within 90 days prior to screening\n* Have been taking drugs to promote body weight reduction, including over-the-counter medications, within 90 days prior to screening\n* Have a prior or planned surgical treatment for obesity\n* Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes'}, 'identificationModule': {'nctId': 'NCT07035093', 'acronym': 'TRIUMPH-7', 'briefTitle': 'A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Who Have Obesity or Overweight and Chronic Low Back Pain', 'orgStudyIdInfo': {'id': '27278'}, 'secondaryIdInfos': [{'id': 'J1I-MC-GZQD', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2024-517431-43-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retatrutide', 'description': 'Participants will receive Retatrutide subcutaneously (SC)', 'interventionNames': ['Drug: Retatrutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive Placebo SC', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Retatrutide', 'type': 'DRUG', 'otherNames': ['LY3437943'], 'description': 'Administered SC', 'armGroupLabels': ['Retatrutide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85286', 'city': 'Chandler', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '480-508-1038'}, {'name': 'Hemant Pandey', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD First Research - Chandler', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '520-404-0276'}, {'name': 'Nebojsa Skrepnik', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tucson Orthopaedic Institute - North Wyatt Drive', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '714-988-2021'}, {'name': 'Justin Yanuck', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ark Clinical Research - Fountain Valley', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '714-626-8610'}, {'name': 'Shirley Pang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St Joseph Heritage Healthcare', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': 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Laura Maffei- Investigacion Clinica Aplicada', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1426ABP', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '5411 7078 1548'}, {'name': 'Marina Uhrig', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundación Respirar', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '2152', 'city': 'Granadero Baigorria', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '543415593898'}, {'name': 'Juan Escalante', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Investigaciones Clínicas Baigorria', 'geoPoint': {'lat': -32.85683, 'lon': -60.71754}}, {'zip': '2000', 'city': 'Rosario', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '03416744474'}, {'name': 'Juan Loureyro', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro Rosarino de Investigaciones Clinicas (CRICs)', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '2000', 'city': 'Rosario', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '3416176661'}, {'name': 'Natacha Maldonado', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto Médico Catamarca IMEC', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '3000', 'city': 'Santa Fe', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '5493424087292'}, {'name': 'Antonio Saleme', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Diagnóstico y Rehabilitación (CEDIR)', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'zip': 'L6T 0G1', 'city': 'Brampton', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'role': 'CONTACT', 'phone': '9054589033'}, {'name': 'Naresh Aggarwal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aggarwal and Associates Limited', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'L8J 0B6', 'city': 'Hamilton', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'role': 'CONTACT', 'phone': '365-366-6267'}, {'name': 'Steven Zizzo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Winterberry Research Inc.', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N7T 4X3', 'city': 'Sarnia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'role': 'CONTACT', 'phone': '15193446612'}, {'name': "John O'Mahony", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bluewater Clinical Research Group Inc.', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'zip': 'B1M 0A1', 'city': 'Sydney', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Tony Valente', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Care Access - Cape Breton', 'geoPoint': {'lat': 46.1351, 'lon': -60.1831}}, {'zip': 'M9V 4B4', 'city': 'Toronto', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'role': 'CONTACT', 'phone': '6473442020'}, {'name': 'Anil Gupta', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dr. Anil K. 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