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Clinical Trial NCT07412756 (RENEW-MDD-1) for Depressive Disorder, Major is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
A Study of Brenipatide in Adult Participants With Major Depressive Disorder (RENEW-MDD-1) Phase 3 1,000
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. ...
Show MoreA 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)
- RENEW-MDD-1
- 27363
- 2025-522308-25-00 (EU Study (CTIS) Number)
- J2S-MC-GZMH (Other Identifier) (Eli Lilly and Company)
Mood Disorders
Depression
Depressive Disorder
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalBrenipatide Dose 1 Brenipatide administered subcutaneously (SC) + standard of care (SoC). | Brenipatide Administered SC |
ExperimentalBrenipatide Dose 2 Brenipatide administered SC + SoC | Brenipatide Administered SC |
ExperimentalBrenipatide Dose 3 Brenipatide administered SC + SoC | Brenipatide Administered SC |
Placebo ComparatorPlacebo Placebo administered SC + SoC. | Placebo Administered SC |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) | From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
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
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
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