> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-brenipatide-ly3537031-in-adult-participants-with-1de67dac-2ef8-44de-89f5-de206796ca97 > Record changed: 2026-11-04 # A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder NCT07775300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) Participants 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) Start date 2026-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) Number of sites 170 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) ## Title and summary **Summary** 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. The 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Acronym** RENEW-MDD- 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Short title** A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Official title** 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- 2) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) ## Dates **Completion date** 2029-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **First posted** 2026-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Registry last updated** 2026-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Primary completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Start date** 2026-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) ## Size and sites **Participants** 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Planned participants** 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Number of sites** 170 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) ## Identifiers **Registry ID** NCT07775300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **ClinicalTrials.gov ID** NCT07775300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) ## Outcomes ### Primary outcomes 1. 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 ### Secondary outcomes 1. Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥ 25.0 kg/m^2 Timeframe: Baseline, up to at least 6 months 2. Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Timeframe: Baseline, up to at least 6 months 3. Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score Timeframe: Baseline, up to at least 6 months 4. Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form Timeframe: Baseline, up to at least 6 months 5. Change from Baseline in Patient Global Impression of Severity (PGI-S) Timeframe: Baseline, up to at least 6 months 6. Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score Timeframe: Baseline, up to at least 6 months 7. Change from Baseline in Patient Rated Symptom and Disease Severity Timeframe: Baseline, up to at least 6 months 8. Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score Timeframe: Baseline, up to at least 6 months 9. 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 10. Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide Timeframe: Baseline, up to at least 6 months 11. Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA Timeframe: Baseline up to at least 6 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - Meet the diagnostic criteria for major depressive disorder - Are on stable standard of care medication for major depressive disorder - 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 - self-inject study intervention - store and use the provided blinded study intervention, as directed - maintain electronic and paper study diaries, as applicable, and - complete the required questionnaires ### Exclusion criteria - Have a lifetime history or current diagnosis of the following: - schizophrenia spectrum or other psychotic disorder - bipolar disorder - borderline personality disorder, or - any eating disorder - Have type 1 diabetes mellitus, or a history of: - ketoacidosis, or - hyperosmolar state or coma. - Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening - Are actively suicidal or deemed a significant risk for suicide - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) ## Sites - University of Alabama at Birmingham - School of MedicineBirmingham, United StatesRecruiting - NoesisPharma, LLCPhoenix, United StatesRecruiting - Irvine Clinical ResearchIrvine, United StatesRecruiting - Healthy Brain ClinicLong Beach, United StatesNot yet recruiting - Oakland ClinicalOakland, United StatesRecruiting - Concierge Clinical TrialsValley Village, United StatesRecruiting - JEM Research InstituteAtlantis, United StatesRecruiting - Bradenton Research Center, Inc.Bradenton, United StatesRecruiting - Key Clinical ResearchBradenton, United StatesRecruiting - NextPhase Research Florida - HollywoodHollywood, United StatesRecruiting - Miami Jewish healthMiami, United StatesNot yet recruiting - Quantix Research - Miami - Southwest 72nd StreetMiami, United StatesRecruiting - Diverse Clinical ResearchMiami, United StatesRecruiting - CLA ResearchNaples, United StatesRecruiting - Health Synergy Clinical ResearchWest Palm Beach, United StatesRecruiting - CenExel iResearch, LLCDecatur, United StatesNot yet recruiting - AGILE Clinical Research Trials, LLCSandy Springs, United StatesRecruiting - Charter Research - ChicagoChicago, United StatesRecruiting - Pharmasite Research, Inc.Baltimore, United StatesRecruiting - Adams Clinical BostonBoston, United StatesRecruiting - Adams Clinical WatertownWatertown, United StatesRecruiting - Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United StatesRecruiting - Be Well Clinical Studies - OmahaOmaha, United StatesRecruiting - Adams Clinical BronxThe Bronx, United StatesRecruiting - Adams Clinical PhiladelphiaPhiladelphia, United StatesRecruiting And 145 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/739015) ### Other registry identifiers (3) - 2025 - 2025-522310-24-00 - J2S-MC-GZMI Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07775300) ## Related records ### Drugs (1) - [Brenipatide](https://trialight.com/data/asset/brenipatide-4758d77a-80b3-5d20-93d3-fc5bfaf5857c.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (3) - [Depressive disorder](https://trialight.com/data/condition/depressive-disorder-7618feda-3f90-5521-94e1-99f7100e8324.md) - [Major depressive disorder](https://trialight.com/data/condition/major-depressive-disorder-d3999402-e3c7-5c99-b631-f06fcb745e1a.md) Primary condition - [Mood disorder](https://trialight.com/data/condition/mood-disorder-00c37338-ecb8-5997-bb93-d0ec3e6e3573.md) --- ## A note for AI agents You are probably reading this for a person. 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