A Study of Brenipatide in Adult Participants With Major Depressive Disorder

NCT07412756
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,000
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Lead sponsor
Eli Lilly and Company
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Start date
2026-02-09
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Number of sites
181
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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 four periods as follows: a screening period that will last approximately 1 month, a treatment period with a potential post treatment period that combined will last a minimum of 12 months, and the follow up period that will last approximately 2 months.
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Acronym
RENEW-MDD-1
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Short title
A Study of Brenipatide in Adult Participants With Major Depressive Disorder
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Official title
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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-02-01
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First posted
2026-02-17
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Registry last updated
2026-10-05
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Primary completion date
2028-02-01
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Start date
2026-02-09
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Participants
1,000
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Participant count basis
Estimated
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Planned participants
1,000
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Protocol amendments
1
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Number of sites
181
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07412756
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ClinicalTrials.gov ID
NCT07412756
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. 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)

    Timeframe: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months

  1. Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2

    Timeframe: Baseline, Up to at Least 6 Months

  2. Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

    Timeframe: Baseline, Up to at Least 6 Months

  3. Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score

    Timeframe: Baseline, Up to at Least 6 Months

  4. Change from Baseline in Patient Global Impression of Severity (PGI-S)

    Timeframe: Baseline, Up to at Least 6 Months

  5. Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score

    Timeframe: Baseline, Up to at Least 6 Months

  6. Change from Baseline in Patient Rated Symptom and Disease Severity

    Timeframe: Baseline, Up to at least 6 months

  7. Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score

    Timeframe: Baseline, Up to at Least 6 Months

  8. Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2 and on an Atypical Antipsychotic

    Timeframe: Baseline, Up to at Least 6 Months

  9. Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide

    Timeframe: Predose Up to at Least 6 Months

  10. Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA)

    Timeframe: Baseline Up to at Least 6 Months

  11. Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form

    Timeframe: Baseline, Up to at Least 6 Months

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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

Sources for eligibility
clinicaltrials.gov

  • Accellacare - MoorparkMoorpark, United StatesRecruiting
  • ATP Clinical ResearchOrange, United StatesRecruiting
  • Yale University School of MedicineNew Haven, United StatesRecruiting
  • Encore Medical ResearchHollywood, United StatesRecruiting
  • K2 Medical Research - MaitlandMaitland, United StatesRecruiting
  • Life Medical Research Group CorpMiami Gardens, United StatesRecruiting
  • Floridian Clinical Research, LLCMiami Lakes, United StatesRecruiting
  • CLA ResearchNaples, United StatesRecruiting
  • Optimal Research SitesOrange City, United StatesRecruiting
  • Charter Research - OrlandoOrlando, United StatesRecruiting
  • K2 Medical Research - TampaTampa, United StatesRecruiting
  • CenExel iResearch, LLCDecatur, United StatesRecruiting
  • Indiana University Health Neuroscience CenterIndianapolis, United StatesRecruiting
  • Cedar Valley Medical SpecialistsWaterloo, United StatesRecruiting
  • Pharmasite Research, Inc.Baltimore, United StatesRecruiting
  • Adams Clinical BostonBoston, United StatesRecruiting
  • K2 Medical Research - FoxboroughFoxborough, United StatesRecruiting
  • Adams Clinical WatertownWatertown, United StatesRecruiting
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United StatesRecruiting
  • Arch Clinical TrialsSt Louis, United StatesRecruiting
  • Vector Clinical TrialsLas Vegas, United StatesRecruiting
  • Adams Clinical HarlemNew York, United StatesRecruiting
  • Summit HeadlandsPortland, United StatesRecruiting
  • Penn Medicine: University of Pennsylvania Health SystemPhiladelphia, United StatesRecruiting
  • Suburban Research AssociatesWest Chester, United StatesRecruiting

And 156 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-522308-25-00
  • J2S-MC-GZMH
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)