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)
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)
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.
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
Exclusion Criteria:
Have a lifetime history or current diagnosis of the following:
Have type 1 diabetes mellitus, or a history of:
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
LillyTrials@Lilly.com1-317-615-4559
clinical_inquiry_hub@lilly.com
205-934-2484
Shibuya-ku, 151-0053, Japan
81120023812
Ciudad de Tijuana, 22105, Mexico