A Phase 2 interventional study of Brenipatide and Placebo in Major Depressive Disorder, sponsored by Eli Lilly and Company. Not yet recruiting at 75 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
This study evaluates the safety and efficacy of brenipatide (LY3537031) as an add on therapy in participants with major depression who still have symptoms while taking a stable dose of standard of care anti-depressant medicine.
The study will last approximately 5 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 330 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) anti-depressant
Drug: Brenipatide
Placebo administered SC + SoC anti-depressant
Drug: Placebo
Administered SC
Also known as: LY3537031
Administered SC
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS-9) Score
Time frame: Baseline, Week 10
Change from Baseline in Hamilton Depression Rating Scale Score
Time frame: Baseline, Week 10
Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score
Time frame: Baseline, Week 10
Achievement of Body Weight Reduction ≥5% in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m²
Time frame: Baseline, Week 10
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA)
Time frame: Baseline, Up to Week 18
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 European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
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 ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Brenipatide