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A Study of Brenipatide in Adult Participants With Major Depressive Disorder

ConditionDepressive Disorder, Major
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company

About 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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

schizophrenia or other psychotic disorder

bipolar disorder

borderline personality disorder, or

any eating disorder.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brenipatide

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

1,000 Participants
are divided into 4 treatment groups
Group A: Brenipatide Dose 1Experimental treatment 1 intervention
Group B: Brenipatide Dose 2Experimental treatment 1 intervention
Group C: Brenipatide Dose 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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)

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

Secondary outcomes

1

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

Time frame
Baseline, Up to at Least 6 Months
2

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

Time frame
Baseline, Up to at Least 6 Months
3

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

Time frame
Baseline, Up to at Least 6 Months
4

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

Time frame
Baseline, Up to at Least 6 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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