Depressive Disorder, Major study: Brenipatide
Official title A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
ClinicalTrials.gov ID: NCT07775300
What this study is testing
What is Brenipatide?
An investigational subcutaneous injectable medicine being studied as a potential treatment for major depressive 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
- This study aims to find out if brenipatide, taken with standard care, is better than a fake pill at keeping depression symptoms away.
- Who it's for
- The study is looking for adults who have major depressive disorder.
- What's involved
- Participants will receive either the new drug or a placebo along with their usual treatment. They will attend regular visits for check-ups and tests.
- Time commitment
- Participation lasts at least 14 months, including a 1-month screening, a 12-month treatment phase, and a 2-month follow-up.
- Phase 3: a large, late-stage study
- 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 major depressive disorder
- Are on 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...
- self-inject study intervention
- store and use the provided blinded study intervention, as directed
You likely can't join if
- schizophrenia spectrum or other psychotic disorder
- bipolar disorder
- borderline personality disorder, or
- any eating disorder
- ketoacidosis, or
- hyperosmolar state or coma.
See the full eligibility criteria
- Meet the diagnostic criteria for major depressive disorder
- Are on 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
- store and use the provided blinded study intervention, as directed
- maintain electronic and paper study diaries, as applicable, and
- complete the required questionnaires
- schizophrenia spectrum or other psychotic disorder
- bipolar disorder
- borderline personality disorder, or
- any eating disorder
- ketoacidosis, or
- hyperosmolar state or coma.
- Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
- Are actively suicidal or deemed a 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 is enrolling
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Irvine, California, United States
- Oakland, California, United States
- Valley Village, California, United States
- Atlantis, Florida, United States
- Bradenton, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Naples, Florida, United States
- West Palm Beach, Florida, United States
- Sandy Springs, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Watertown, Massachusetts, United States
- Troy, Michigan, United States
- Omaha, Nebraska, United States
- The Bronx, New York, United States
- Philadelphia, Pennsylvania, United States
+ 24 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, but 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?
This study is enrolling now at Birmingham, Alabama, United States; Phoenix, Arizona, United States; Irvine, California, United States; Oakland, California, United States; Valley Village, California, United States; Atlantis, Florida, United States and 38 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.