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RECRUITINGPhase 2INTERVENTIONAL

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

A Phase 2, 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 Bipolar Disorder (RENEW-Bipolar-1)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - maintain electronic and paper study diaries, as applicable, and - complete the required questionnaires - Are on stable standard of care medication for bipolar disorder Who Should NOT Join This Trial: - Have a lifetime history or current diagnosis of the following according to DSM-5 criteria: - schizophrenia or other psychotic disorder - borderline personality disorder, or - any eating disorder - Have type 1 diabetes mellitus, or a history of - ketoacidosis, or - hyperosmolar state or coma - Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening - Are actively suicidal and or deemed to be at 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 * maintain electronic and paper study diaries, as applicable, and * complete the required questionnaires * Are on stable standard of care medication for bipolar disorder Exclusion Criteria: * Have a lifetime history or current diagnosis of the following according to DSM-5 criteria: * schizophrenia or other psychotic disorder * borderline personality disorder, or * any eating disorder * Have type 1 diabetes mellitus, or a history of * ketoacidosis, or * hyperosmolar state or coma * Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening * Are actively suicidal and or deemed to be at 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

Treatments Being Tested

DRUG

Brenipatide

Administered SC

DRUG

Placebo

Administered SC

Locations (20)

ATP Clinical Research
Orange, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
AGA Clinical Trials
Hialeah, Florida, United States
Accel Research Sites - Maitland Clinical Research Unit
Maitland, Florida, United States
K2 Medical Research - Maitland
Maitland, Florida, United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States
CLA Research
Naples, Florida, United States
Charter Research - Orlando
Orlando, Florida, United States
Encore Medical Research - Weston
Weston, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Covenant Medical Center
Waterloo, Iowa, United States
CBH Health
Gaithersburg, Maryland, United States
Elixia MA
Springfield, Massachusetts, United States
Adams Clinical Watertown
Watertown, Massachusetts, United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Revival Research Institute, LLC
McKinney, Texas, United States
Pillar Clinical Research - Richardson
Richardson, Texas, United States
Alpine Research Organization
Clinton, Utah, United States
Re:Cognition Health
Fairfax, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States