Brenipatide for Depression
(RENEW-MDD- 2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
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Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with major depressive disorder who are currently receiving standard depression treatment. Participants should be generally healthy aside from their depression and able to follow study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Brenipatide or placebo administered subcutaneously along with standard of care to delay the return of major depressive symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Brenipatide
Trial Overview
The study compares a new drug, brenipatide, plus usual depression care against a placebo plus usual care to see if it helps delay the return of major depressive symptoms. Treatment lasts at least 12 months, with screening and follow-up periods.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Brenipatide administered SC + SoC.
Brenipatide administered SC + SoC.
Brenipatide administered subcutaneous (SC) + standard of care (SoC).
Placebo administered SC + SoC.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
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