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 1)
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 1,000
- Locations
- 186
- Primary Endpoint
- 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)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- 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
Arms & Interventions
Brenipatide Dose 2
Brenipatide administered SC + SoC
Intervention: Brenipatide (Drug)
Brenipatide Dose 3
Brenipatide administered SC + SoC
Intervention: Brenipatide (Drug)
Brenipatide Dose 1
Brenipatide administered subcutaneously (SC) + standard of care (SoC).
Intervention: Brenipatide (Drug)
Placebo
Placebo administered SC + SoC.
Intervention: Placebo (Drug)
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 kg/m2(Baseline, Up to at Least 6 Months)
- Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score(Baseline, Up to at Least 6 Months)
- Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score(Baseline, Up to at Least 6 Months)
- Change from Baseline in Patient Global Impression of Severity (PGI-S)(Baseline, Up to at Least 6 Months)
- Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score(Baseline, Up to at Least 6 Months)
- Change from Baseline in Patient Rated Symptom and Disease Severity(Baseline, Up to at least 6 months)
- Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score(Baseline, Up to at Least 6 Months)
- Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2 and on an Atypical Antipsychotic(Baseline, Up to at Least 6 Months)
- Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide(Predose Up to at Least 6 Months)
- Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA)(Baseline Up to at Least 6 Months)
- Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form(Baseline, Up to at Least 6 Months)