A Study of Brenipatide in Participants With Major Depressive Disorder (RENEW-MDD-3)

November 5, 2026 updated by: Eli Lilly and Company

A Phase 2, Multicenter, Randomized, Double-blind, Parallel-arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide Compared With Placebo in Adult Participants With Major Depressive Disorder Who Have Partial Response to Antidepressant Therapy (RENEW-MDD-3)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • UMHAT Dr Georgi Stranski
        • Principal Investigator:
          • Maya Stoimenova-Popova
      • Plovdiv, Bulgaria, 4004
        • Medical Center MentalCare
        • Principal Investigator:
          • Stanka Yazova
      • Sofia, Bulgaria, 1000
        • Mental Health Center - Sofia EOOD
        • Principal Investigator:
          • Emil Grashnov
      • Varna, Bulgaria, 9020
        • DCC Mladost-M Varna OOD
        • Principal Investigator:
          • Hristo Kozhuharov
      • Vratsa, Bulgaria, 3001
        • Mental Health Center - Vratsa
        • Principal Investigator:
          • Nadya Ivanova
  • Hungary
      • Budapest, Hungary, 1033
        • Clinexpert Gyöngyös
        • Principal Investigator:
          • Tiberiu Dina
      • Gyöngyös, Hungary, 3200
        • Clinexpert Gyöngyös
        • Principal Investigator:
          • Anita Kiss
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5223 LA
        • Brain Research Center Den Bosch B.V.
        • Principal Investigator:
          • Roel Mocking
      • Amsterdam, Netherlands, 1081 GM
        • Alzheimer's Research Center
        • Principal Investigator:
          • Roel Mocking
      • Groningen, Netherlands, 9700 RB
        • University Medical Center Groningen
        • Principal Investigator:
          • Robert Schoevers
      • Leiden, Netherlands, 2333 ZA
        • Leids Universitair Medisch Centrum
        • Principal Investigator:
          • Nic van der Wee
      • Zwolle, Netherlands, 8025 AZ
        • Brain Research Center Zwolle
        • Principal Investigator:
          • Roel Mocking
  • Poland
      • Bialystok, Poland, 15-404
        • MłynowaMed Specialist Psychiatric Medical Practice Joanna Łazarczyk
        • Principal Investigator:
          • Joanna Lazarczyk
      • Bialystok, Poland, 15-464
        • Wlokiennicza Praktyka Lekarska dr n. med. Tomasz Markowski
        • Principal Investigator:
          • Tomasz Markowski
      • Bydgoszcz, Poland, 85-133
        • Promente - Center of Neurology and Psychogeriatrics
        • Principal Investigator:
          • Katarzyna Lachut
      • Gdansk, Poland, 80-211
        • Gdanski Uniwersytet Medyczny
        • Principal Investigator:
          • Karol Grabowski
      • Gdansk, Poland, 80-546
        • Penta Hospitals Badania Kliniczne - Gdańsk 1
        • Principal Investigator:
          • Katarzyna Binkowska-Michalik
      • Lodz, Poland, 91 495
        • AmiCare Sp. z o.o. Sp. K.
        • Principal Investigator:
          • Katarzyna Przybyłowska- Kustosik
      • Lublin, Poland, 20-064
        • Instytut Naukowo-Badawczy w Lublinie Sp. z o.o.
        • Principal Investigator:
          • Grzegorz Opielak
      • Olkusz, Poland, 32-300
        • Nowy Szpital w Olkuszu
        • Principal Investigator:
          • Katarzyna Urbańczyk-Łosień
      • Rybnik, Poland, 44-200
        • M2M Med Badania Sp. Z o.o
        • Principal Investigator:
          • Wojciech Eysymontt
      • Suchy Las, Poland, 62-002
        • Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda
        • Principal Investigator:
          • Agnieszka Remlinger
      • Warsaw, Poland, 02-957
        • IPIN Warsaw - Instytut Psychiatrii i Neurologii w Warszawie (IPIN)
        • Principal Investigator:
          • Adam Wichniak
  • Romania
      • Bragadiru, Romania, 077025
        • Ames Research Center S.R.L.
        • Principal Investigator:
          • Dan Rosu
      • Bucharest, Romania, 41914
        • Prof. Dr. Alexandru Obregia Psychiatry Hospital
        • Principal Investigator:
          • Adela Ciobanu
      • Bucharest, Romania, 031441
        • Futuremeds - București
        • Principal Investigator:
          • Alexandru Pavel
      • Bucharest, Romania, 020744
        • Clinic Nutrimed Cercetare S.R.L.
        • Principal Investigator:
          • Marian Onofreiu
      • Galati, Romania, 800179
        • Spitalul De Psihiatrie Elisabeta- Domna- Galati
        • Principal Investigator:
          • Claudiu Ionut Vasile
      • Galati, Romania, 800183
        • FutureMeds SRL - Galati
        • Principal Investigator:
          • Mihai Mutica
  • Spain
      • Alcorcón, Spain, 28922
        • Hospital Fundación Alcorcón
        • Principal Investigator:
          • Francisco Montanes Rada
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Josep-Antoni Ramos-Quiroga
      • Madrid, Spain, 28022
        • Clinica Universidad Navarra-Sede Madrid
        • Principal Investigator:
          • Patricio Molero Santos
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
        • Principal Investigator:
          • ANGEL MONTEJO
      • Valdemoro, Spain, 28342
        • Hospital Universitario Infanta Elena
        • Principal Investigator:
          • Enrique Baca-Garcia
      • Vigo, Spain, 36213
        • Hospital Álvaro Cunqueiro
        • Principal Investigator:
          • Jose Antonio Campos Perez
      • Zamora, Spain, 49022
        • Hospital Virgen De La Concha
        • Principal Investigator:
          • Juan Antonio Mellado
  • United Kingdom
      • Doncaster, United Kingdom, DN4 8QN
        • Clerkenwell Health - Doncaster
        • Principal Investigator:
          • Ibreez Ajaz
      • Exeter, United Kingdom, EX2 5AF
        • Devon Partnership Trust
        • Principal Investigator:
          • Merryn Anderson
      • London, United Kingdom, W1U 6RP
        • Clerkenwell Health - London - Baker Street
        • Principal Investigator:
          • Alishah Suleman
      • London, United Kingdom, SE5 8AZ
        • The Maudsley Hospital
        • Principal Investigator:
          • Mario Juruena
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • IMA Clinical Research - Phoenix
        • Principal Investigator:
          • Payam Sadr
    • California
      • Chino, California, United States, 91710
        • Inland Psychiatric Medical Group
        • Principal Investigator:
          • Nandita Puchakayala
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
        • Principal Investigator:
          • Stephen Volk
      • Oceanside, California, United States, 92056
        • Excell Research
        • Principal Investigator:
          • Sherry Soefje
      • Sherman Oaks, California, United States, 91403
        • California Neuroscience Research Medical Group, Inc.
        • Principal Investigator:
          • Iman Parhami
      • West Hills, California, United States, 91307
        • Alliance Clinical West Hills
        • Principal Investigator:
          • Clifford Feldman
    • Florida
      • Hollywood, Florida, United States, 33021-6758
        • The Medici Medical Research
        • Principal Investigator:
          • Yesenia Kuan
      • Hollywood, Florida, United States, 33024
        • Research Centers of America, LLC-Hollywood
        • Principal Investigator:
          • Edwin Gomez
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
        • Principal Investigator:
          • Nandita Jones
      • Orlando, Florida, United States, 32807
        • Combined Research Orlando Phase I-IV LLC
        • Principal Investigator:
          • Eric Carbonell
      • Plant City, Florida, United States, 33563
        • Denali Health - Plant City, FL
        • Principal Investigator:
          • Walid Aziz
      • Tampa, Florida, United States, 33613
        • ForCare Clinical Research
        • Principal Investigator:
          • Marlene Hart
      • West Palm Beach, Florida, United States, 33407
        • Neuroscience Research Institute - West Palm Beach
        • Principal Investigator:
          • Danesh Alam
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
        • Principal Investigator:
          • Elyssa Barron
      • Atlanta, Georgia, United States, 30328
        • Synexus Clinical Research
        • Principal Investigator:
          • Bethany Davis
      • Decatur, Georgia, United States, 30030
        • CenExel iResearch, LLC
        • Principal Investigator:
          • Saundra Maass Robinson
      • Savannah, Georgia, United States, 31405
        • CenExel iResearch, LLC
        • Principal Investigator:
          • Michael Mobley
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Boston Clinical Trials
        • Principal Investigator:
          • Irina Mezhebovsky
      • Boston, Massachusetts, United States, 02116
        • Adams Clinical Boston
        • Principal Investigator:
          • Darin Dougherty
      • Watertown, Massachusetts, United States, 02472
        • Adams Clinical
        • Principal Investigator:
          • Stephanie Ellickson
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • IMA Clinical Research Las Vegas
        • Principal Investigator:
          • Mustafa Rawaf
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Hassman Research Institute Marlton Site
        • Principal Investigator:
          • Elan Cohen
      • Toms River, New Jersey, United States, 08755
        • Bio Behavioral Health
        • Principal Investigator:
          • Ashok Patel
    • New York
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research Inc
        • Principal Investigator:
          • Ronald Brenner
      • Mount Kisco, New York, United States, 10128
        • Bioscience Research, LLC
        • Principal Investigator:
          • David Krakow
      • New York, New York, United States, 10029
        • Adams Clinical Harlem
        • Principal Investigator:
          • Rachel Noone
      • New York, New York, United States, 10036
        • IMA Clinical Research NYC Midtown
        • Principal Investigator:
          • Eli Shalenberg
      • Staten Island, New York, United States, 10314
        • Richmond Behavioral Associates
        • Principal Investigator:
          • Adam Smith
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Center for Clinical Research
        • Principal Investigator:
          • Paul Gross
      • Philadelphia, Pennsylvania, United States, 19104
        • Adams Clinical Philadelphia
        • Principal Investigator:
          • Cassie Blanchard
    • Texas
      • Austin, Texas, United States, 78731
        • IMA Clinical Research Austin - Northland
        • Principal Investigator:
          • Charles Sweet
      • Dallas, Texas, United States, 75243
        • Lonestar Clinical Research
        • Principal Investigator:
          • Lili Meisamy
      • DeSoto, Texas, United States, 75115
        • Adams Clinical Dallas
        • Principal Investigator:
          • Benji Kurian
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • Inspire Behavioral Health
        • Principal Investigator:
          • Bhagwan Bahroo
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
        • Principal Investigator:
          • Wisam Al jumaili

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a diagnosis of Major Depressive Disorder (MDD) and are in a current major depressive episode, without psychotic features

  • Are on a stable antidepressant monotherapy regimen for the current major depressive episode

  • Are a partial responder to the current antidepressant monotherapy regimen

  • 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 or other psychotic disorder
    • bipolar disorder
    • borderline personality disorder
    • other personality disorders that would interfere with compliance with the study protocol
    • neurocognitive disorders or intellectual disability, or
    • any eating disorder

  • Have type 1 diabetes mellitus, or a history of

    • ketoacidosis, or
    • hyperosmolar state or coma

  • Have had a history of any substance or alcohol use disorder of any severity within 180 days before Visit 1

  • 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 Visit 1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Brenipatide

Brenipatide administered subcutaneously (SC) + standard of care (SoC) anti-depressant
Drug: Brenipatide

Administered SC

Other Names:
  • LY3537031
Placebo Comparator: Placebo

Placebo administered SC + SoC anti-depressant
Drug: Placebo

Administered SC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS-9) Score
Time Frame: Baseline, Week 10
Baseline, Week 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in Hamilton Depression Rating Scale Score
Time Frame: Baseline, Week 10
Baseline, Week 10
Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score
Time Frame: Baseline, Week 10
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
Baseline, Week 10
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA)
Time Frame: Baseline, Up to Week 18
Baseline, Up to Week 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27873
  • J2S-MC-GZMW (Other Identifier: Eli Lilly and Company)
  • 2026-527689-65-00 (Other Identifier: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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