Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:22 PM
Study NCT ID:
NCT07412756
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)', 'timeFrame': 'From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months'}], 'secondaryOutcomes': [{'measure': 'Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2', 'timeFrame': 'Baseline, Up to at Least 6 Months'}, {'measure': 'Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score', 'timeFrame': 'Baseline, Up to at Least 6 Months'}, {'measure': 'Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score', 'timeFrame': 'Baseline, Up to at Least 6 Months'}, {'measure': 'Change from Baseline in Patient Global Impression of Severity (PGI-S)', 'timeFrame': 'Baseline, Up to at Least 6 Months'}, {'measure': 'Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score', 'timeFrame': 'Baseline, Up to at Least 6 Months'}, {'measure': 'Change from Baseline in Patient Rated Symptom and Disease Severity', 'timeFrame': 'Baseline, Up to at least 6 months'}, {'measure': 'Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score', 'timeFrame': 'Baseline, Up to at Least 6 Months'}, {'measure': 'Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2 and on an Atypical Antipsychotic', 'timeFrame': 'Baseline, Up to at Least 6 Months'}, {'measure': 'Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide', 'timeFrame': 'Predose Up to at Least 6 Months'}, {'measure': 'Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA)', 'timeFrame': 'Baseline Up to at Least 6 Months'}, {'measure': 'Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form', 'timeFrame': 'Baseline, Up to at Least 6 Months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Major Depressive Episode', 'Mood Disorders', 'Depression', 'Depressive Disorder'], 'conditions': ['Depressive Disorder, Major']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/ext/trial?id=J2S-MC-GZMH', 'label': 'Lilly Trials'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms.\n\nThe trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the diagnostic criteria for major depressive disorder\n* Are on a stable standard of care medication for major depressive disorder\n* Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n * self-inject study intervention\n * store and use the provided blinded study intervention, as directed\n * maintain electronic and paper study diaries, as applicable, and\n * complete the required questionnaires\n\nExclusion Criteria:\n\n* Have a lifetime history or current diagnosis of the following:\n\n * schizophrenia or other psychotic disorder\n * bipolar disorder\n * borderline personality disorder, or\n * any eating disorder.\n* Have type 1 diabetes mellitus, or a history of\n\n * ketoacidosis, or\n * hyperosmolar state or coma.\n* Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening\n* Are actively suicidal or deemed a significant risk for suicide\n* Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening'}, 'identificationModule': {'nctId': 'NCT07412756', 'acronym': 'RENEW-MDD-1', 'briefTitle': 'A Study of Brenipatide in Adult Participants With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD 1)', 'orgStudyIdInfo': {'id': '27363'}, 'secondaryIdInfos': [{'id': '2025-522308-25-00', 'type': 'CTIS'}, {'id': 'J2S-MC-GZMH', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brenipatide Dose 1', 'description': 'Brenipatide administered subcutaneously (SC) + standard of care (SoC).', 'interventionNames': ['Drug: Brenipatide']}, {'type': 'EXPERIMENTAL', 'label': 'Brenipatide Dose 2', 'description': 'Brenipatide administered SC + SoC', 'interventionNames': ['Drug: Brenipatide']}, {'type': 'EXPERIMENTAL', 'label': 'Brenipatide Dose 3', 'description': 'Brenipatide administered SC + SoC', 'interventionNames': ['Drug: Brenipatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered SC + SoC.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Brenipatide', 'type': 'DRUG', 'otherNames': ['LY3537031'], 'description': 'Administered SC', 'armGroupLabels': ['Brenipatide Dose 1', 'Brenipatide Dose 2', 'Brenipatide Dose 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93021', 'city': 'Moorpark', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '747-998-0394'}, {'name': 'Arjun Reyes', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Accellacare - Moorpark', 'geoPoint': {'lat': 34.28556, 'lon': -118.88204}}, {'zip': '92866', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '949-354-5353'}, {'name': 'Gustavo Alva', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ATP Clinical Research', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '06519', 'city': 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Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. 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