Anxiety & Depression Association of America

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

Purpose

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.

Condition

Depressive Disorder, Major

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Meet the diagnostic criteria for major depressive disorder - Are on a 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 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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Brenipatide Dose 1	Brenipatide administered subcutaneously (SC) + standard of care (SoC).	Drug: Brenipatide Administered SC Other names: LY3537031
Experimental Brenipatide Dose 2	Brenipatide administered SC + SoC	Drug: Brenipatide Administered SC Other names: LY3537031
Experimental Brenipatide Dose 3	Brenipatide administered SC + SoC	Drug: Brenipatide Administered SC Other names: LY3537031
Placebo Comparator Placebo	Placebo administered SC + SoC.	Drug: Placebo Administered SC

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.