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Depressive Disorder, Major / Brenipatide · Phase 3 Trial
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 3 randomized controlled trial of brenipatide (LY3537031) versus placebo as adjunctive treatment in major depressive disorder, with time to relapse as the primary outcome over a minimum 12-month treatment period. No efficacy or safety results are reported in this registry record; the study has not yet begun recruitment.
Phase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Depressive Disorder, Major; age from 18 Years; to 75 Years. Intervention: Brenipatide Dose 1; Brenipatide Dose 2; Brenipatide Dose 3. Compared with: Placebo — Placebo Comparator. n = 1,000. 169 sites across 15 countries.
This is a planned Phase 3 randomized controlled trial of brenipatide (LY3537031) versus placebo as adjunctive treatment in major depressive disorder, with time to relapse as the primary outcome over a minimum 12-month treatment period. No efficacy or safety results are reported in this registry record; the study has not yet begun recruitment.
Secondary outcomes, safety data, and participant demographics not listed in registry record.
Once results are available, this trial will provide evidence on whether brenipatide delays relapse in MDD when used as adjunctive therapy. Clinicians should not yet use this information for practice guidance; results are awaited.
This is a Phase 3 registration record with no reported results; the study is not yet recruiting and outcome data are not available in this registry entry.
As stated by the source record.
Quoted from the source exactly as published.
Once results are available, this trial will provide evidence on whether brenipatide delays relapse in MDD when used as adjunctive therapy. Clinicians should not yet use this information for practice guidance; results are awaited.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07775300). This is a study registration, not published results. Lead sponsor: Eli Lilly and Company. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1000 participants (ESTIMATED). Conditions: Depressive Disorder, Major. Interventions: DRUG: Brenipatide; DRUG: Placebo. Primary outcome measures: 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) , From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.