BridgeMD
New treatment option for Schizophrenia
Official title A Study of Brenipatide in Adult Participants With Schizophrenia
ClinicalTrials.gov ID: NCT07410507
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 schizophrenia.
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 to placebo plus SoC for treatment of schizophrenia. The trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period 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.
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 55
You may be able to join if
- Meet the diagnostic criteria of schizophrenia
- Are on a stable standard of care medication regimen for schizophrenia
- If the duration of illness is \>6 years, participant has experienced at least one relapse of schizophrenia in last 3 years
- Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse)
- 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...
You likely can't join if
- Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder
- Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
- Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma
- Are actively suicidal or deemed to be a significant risk for suicide
- Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be...
See the full eligibility criteria
- Meet the diagnostic criteria of schizophrenia
- Are on a stable standard of care medication regimen for schizophrenia
- If the duration of illness is \>6 years, participant has experienced at least one relapse of schizophrenia in last 3 years
- Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse)
- 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 study intervention as directed,
- maintain electronic or paper study diaries, as applicable, and
- complete the required questionnaires
- Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder
- Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
- Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma
- Are actively suicidal or deemed to be a significant risk for suicide
- Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Bellflower, California, United States
- Garden Grove, California, United States
- Montclair, California, United States
- Stanford, California, United States
- Torrance, California, United States
- Walnut Creek, California, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Cooper City, Florida, United States
- Lauderhill, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Naples, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Chicago, Illinois, United States
- Gaithersburg, Maryland, United States
- Belmont, Massachusetts, United States
+ 65 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Bellflower, California, United States; Garden Grove, California, United States; Montclair, California, United States; Stanford, California, United States; Torrance, California, United States and 79 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.