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A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

ConditionBipolar Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company

About this trial

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms.

The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meet the diagnostic criteria for bipolar disorder I or bipolar disorder II

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

Disqualifiers

schizophrenia or other psychotic disorder

borderline personality disorder, or

any eating disorder

Have type 1 diabetes mellitus, or a history of

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brenipatide

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: Brenipatide Dose 1Experimental treatment 1 intervention
Group B: Brenipatide Dose 2 .Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion

Time frame
Randomization up to at least 6 months

Secondary outcomes

1

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

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 Young Mania Rating Scale (YMRS) Total Score

Time frame
Baseline, up to at least 6 months
4

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

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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