The study is evaluating an investigational medication called Brenipatide, given alongside a participant’s current antidepressant medication, to determine whether it can help reduce symptoms of depression and delay future relapse. Participants will continue their standard antidepressant treatment throughout the study.

Who We’re Looking For

Adults who:

• Have been diagnosed with Major Depressive Disorder (MDD), need confirmation from physician (we can provide a form for you)
• Are currently taking medication for depression
• May qualify based on their medical history and screening assessments

Study Timeline

• Screening: Approximately 4–5 weeks (28–34 days) to ensure that you are fully eligible based on initial site visit, labs, and psychiatric assessment scale results from our clinicians and PI
• Treatment: At least 6 months, with once-weekly self-administered study injections
• Follow-Up: Approximately 8 weeks

What Participation Includes

Participants may complete:

• Medical history review
• Physical examinations
• Blood and urine tests
• ECGs
• Vital signs and weight measurements
• Depression questionnaires
• Cognitive assessments
• Weekly study medication injections
• Ongoing safety monitoring

Participants have approximately a 60% chance of receiving Brenipatide and a 40% chance of receiving placebo. Neither participants nor the study team will know which treatment is assigned during the study.

Compensation

• Study medication provided at no cost
• Study-related procedures provided at no cost
• Reimbursement for eligible study-related expenses
• Compensation for time and participation (where applicable)

Site Principal Investigator (Study Doctor):