Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT07285018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)', 'timeFrame': 'Baseline, Week 8'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score', 'timeFrame': 'Baseline, Week 8'}, {'measure': "Change from Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGI-C)", 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Change from Baseline in Worst Pain Intensity as Measured by NRS', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L)', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Total Amount of Rescue Medication Used Daily During the Treatment Phase', 'timeFrame': 'Week 8'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Peripheral Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the safety and efficacy of study drug LY4065967 for the treatment of diabetic peripheral neuropathic pain (DPNP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have presence of diabetic peripheral neuropathy, of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy Screening Instrument (©University of Michigan)\n* Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.\n* Have an HbA1c \\<11% and on a stable regimen for treatment of diabetes at least 90 days prior to screening\n* Have a body mass index at screening of ≤40 kilogram per meter squared (kg/m2)\n\nExclusion Criteria:\n\n* Are pregnant or breastfeeding\n* Have a history of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to diabetic peripheral neuropathic pain (DPNP)\n* Have lower limb amputation due to diabetes inclusive of great toe (metatarsal bone)\n* Have serum vitamin B12 ≤200 picogram per milliliter (pg/mL)\n* Have an abnormal BP (systolic BP \\>140 mm Hg and diastolic BP\\>90 mm Hg) at screening\n* Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator'}, 'identificationModule': {'nctId': 'NCT07285018', 'acronym': 'NP07', 'briefTitle': 'A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Diabetic Peripheral Neuropathic Pain', 'orgStudyIdInfo': {'id': '27370'}, 'secondaryIdInfos': [{'id': 'H0P-MC-NP07', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'H0P-MC-CPMP', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY4065967', 'description': 'Participants will receive LY4065967 orally.', 'interventionNames': ['Drug: LY4065967']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo orally.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY4065967', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY4065967']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'contacts': [{'name': 'David DeAtkine', 'role': 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Research, LLC', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'contacts': [{'name': 'Michael Lillestol', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lillestol Research', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45432', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Priyesh Mehta', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'META Medical Research Institute', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '74133', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'contacts': [{'name': 'Melita Tate', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'DelRicht Research', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Alan Kivitz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Altoona Center 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'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}