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New treatment option for Bipolar Disorder
Official title A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
ClinicalTrials.gov ID: NCT07286175
What this study is testing
What is Brenipatide?
Brenipatide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for bipolar disorder.
Also referred to as LY3537031.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- self-inject study intervention
- store and use the provided blinded study intervention, as directed
- maintain electronic and paper study diaries, as applicable, and
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- New Haven, Connecticut, United States
- Hialeah, Florida, United States
- Maitland, Florida, United States
- Miami Lakes, Florida, United States
- Naples, Florida, United States
- Orlando, Florida, United States
- Weston, Florida, United States
- Atlanta, Georgia, United States
- Waterloo, Iowa, United States
- Gaithersburg, Maryland, United States
- Springfield, Massachusetts, United States
- Watertown, Massachusetts, United States
- Philadelphia, Pennsylvania, United States
- McKinney, Texas, United States
- Richardson, Texas, United States
- Clinton, Utah, United States
- Fairfax, Virginia, United States
- Bellevue, Washington, United States
- ABB, Argentina
+ 56 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; New Haven, Connecticut, United States; Hialeah, Florida, United States; Maitland, Florida, United States; Miami Lakes, Florida, United States; Naples, Florida, United States and 70 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.