Brenipatide added to standard care for adults with major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial evaluating the safety and efficacy of brenipatide in people with major depressive disorder who are already on stable treatment. Participants are randomly assigned to receive brenipatide or placebo in addition to their current care, with follow-up over a period of at least 12 months and additional safety monitoring. The study includes a screening visit, a treatment/post-treatment phase, and a safety follow-up, and involves self-injections, diary entries, and regular questionnaires. Enrollment requires a confirmed diagnosis, stable baseline therapy, and willingness to adhere to the study procedures.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* Have a lifetime history or current diagnosis of the following:

  * schizophrenia spectrum or other psychotic disorder
  * bipolar disorder
  * borderline personality disorder, or
  * any eating disorder
* Have type 1 diabetes mellitus, or a history of:

  * 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

Where it's running

• University of Alabama at Birmingham - School of Medicine
  Birmingham, Alabama, United States Recruiting
• NoesisPharma, LLC
  Phoenix, Arizona, United States Recruiting
• Irvine Clinical Research
  Irvine, California, United States Recruiting
• Oakland Clinical
  Oakland, California, United States Recruiting
• Concierge Clinical Trials
  Valley Village, California, United States Recruiting
• JEM Research Institute
  Atlantis, Florida, United States Recruiting

+120 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.