A Phase 3 interventional study of Brenipatide and Placebo in Depressive Disorder, Major, sponsored by Eli Lilly and Company. Recruiting at 180 sites in 15 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms.
The trial is divided into four periods as follows: a screening period that will last approximately 1 month, a treatment period with a potential post treatment period that combined will last a minimum of 12 months, and the follow up period that will last approximately 2 months.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Have a lifetime history or current diagnosis of the following:
Have type 1 diabetes mellitus, or a history of
Brenipatide administered subcutaneously (SC) + standard of care (SoC).
Drug: Brenipatide
Brenipatide administered SC + SoC
Drug: Brenipatide
Brenipatide administered SC + SoC
Drug: Brenipatide
Placebo administered SC + SoC.
Drug: Placebo
Administered SC
Also known as: LY3537031
Administered SC
Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)
Time frame: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months
Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2
Time frame: Baseline, Up to at Least 6 Months
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline, Up to at Least 6 Months
Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score
Time frame: Baseline, Up to at Least 6 Months
Change from Baseline in Patient Global Impression of Severity (PGI-S)
Time frame: Baseline, Up to at Least 6 Months
Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score
Time frame: Baseline, Up to at Least 6 Months
Change from Baseline in Patient Rated Symptom and Disease Severity
Time frame: Baseline, Up to at least 6 months
Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score
Time frame: Baseline, Up to at Least 6 Months
Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2 and on an Atypical Antipsychotic
Time frame: Baseline, Up to at Least 6 Months
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time frame: Predose Up to at Least 6 Months
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA)
Time frame: Baseline Up to at Least 6 Months
Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form
Time frame: Baseline, Up to at Least 6 Months
Not enrolling at this site — choose another above.
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Showing the first 100 of 180 sites across 15 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Started Feb 2026 (actual). Primary completion is estimated for Feb 2028, 24 months after the start.
Of 95 industry-sponsored phase 3 interventional studies under Depressive Disorder, Major, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 33. This study's planned 24 months is close to that.
Counting every sponsor, half of 124 studies reached it within 27 months; a quarter within 21 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Brenipatide