A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder

Phase 3Not Yet RecruitingNCT07775300

Eli Lilly and Company1,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,000

Conditions

Depressive Disorder, Major

Interventions

Brenipatide

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (169)

University of Alabama at Birmingham - School of Medicine

Birmingham, Alabama, United States

NoesisPharma, LLC

Phoenix, Arizona, United States

Irvine Clinical Research

Irvine, California, United States

Healthy Brain Clinic

Long Beach, California, United States

Oakland Clinical

Oakland, California, United States

Outcomes

Primary Outcomes

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)

Time frame: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months

Secondary Outcomes

Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥ 25.0 kg/m^2