A Study of Brenipatide in Adult Participants With Major Depressive Disorder
RENEW-MDD-1
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD 1)
3 other identifiers
interventional
1,000
15 countries
186
Brief Summary
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 three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2026
186 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2026
CompletedStudy Start
First participant enrolled
February 9, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
March 23, 2026
March 1, 2026
2 years
February 6, 2026
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months
Secondary Outcomes (11)
Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2
Baseline, Up to at Least 6 Months
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Baseline, Up to at Least 6 Months
Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score
Baseline, Up to at Least 6 Months
Change from Baseline in Patient Global Impression of Severity (PGI-S)
Baseline, Up to at Least 6 Months
Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score
Baseline, Up to at Least 6 Months
- +6 more secondary outcomes
Study Arms (4)
Brenipatide Dose 1
EXPERIMENTALBrenipatide administered subcutaneously (SC) + standard of care (SoC).
Brenipatide Dose 2
EXPERIMENTALBrenipatide administered SC + SoC
Brenipatide Dose 3
EXPERIMENTALBrenipatide administered SC + SoC
Placebo
PLACEBO COMPARATORPlacebo administered SC + SoC.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Meet the diagnostic criteria for major depressive disorder
- Are on a 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
You may not qualify if:
- Have a lifetime history or current diagnosis of the following:
- schizophrenia 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (186)
Accellacare - Moorpark
Moorpark, California, 93021, United States
ATP Clinical Research
Orange, California, 92866, United States
Yale University School of Medicine
New Haven, Connecticut, 06519, United States
Encore Medical Research
Hollywood, Florida, 33024, United States
K2 Medical Research - Maitland
Maitland, Florida, 32751, United States
Life Medical Research Group Corp
Miami Gardens, Florida, 33014, United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016-1518, United States
CLA Research
Naples, Florida, 34116, United States
Optimal Research Sites
Orange City, Florida, 32763, United States
Charter Research - Orlando
Orlando, Florida, 32803, United States
K2 Medical Research - Tampa
Tampa, Florida, 33634, United States
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, 46202, United States
Cedar Valley Medical Specialists
Waterloo, Iowa, 50701, United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208, United States
Adams Clinical Boston
Boston, Massachusetts, 02116, United States
Adams Clinical Watertown
Watertown, Massachusetts, 02472, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
Arch Clinical Trials
St Louis, Missouri, 63141, United States
Vector Clinical Trials
Las Vegas, Nevada, 89128, United States
Adams Clinical Harlem
New York, New York, 10029, United States
Summit Headlands
Portland, Oregon, 97210, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
K2 Medical Research - East Providence
East Providence, Rhode Island, 02914, United States
Circle Clinical Research
Sioux Falls, South Dakota, 57104, United States
Adams Clinical Dallas
DeSoto, Texas, 75115, United States
Re:Cognition Health - Fort Worth
Fort Worth, Texas, 76104, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Alpine Research Organization
Clinton, Utah, 84015, United States
Re:Cognition Health
Fairfax, Virginia, 22031, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Mater Misericordiae Limited
Brisbane, 4101, Australia
NeuroCentrix
Carlton, 3053, Australia
Lyell McEwin Hospital
Elizabeth Vale, 5112, Australia
Barwon Health
Geelong, 3220, Australia
Multidisciplinary Alfred Psychiatry Research Centre
Melbourne, 3004, Australia
Paratus Clinical Research - Melbourne
Melbourne, 3070, Australia
Mildura Base Hospital
Mildura, 3500, Australia
Toowoomba Hospital
Toowoomba, 4350, Australia
Innovate Clinical Research
Waitara, 2077, Australia
Westmead Hospital
Westmead, 2145, Australia
Hospital das Clínicas da UFMG
Belo Horizonte, 30130-100, Brazil
Trial Tech
Curitiba, 80240-280, Brazil
Clinilive
Maringá, 87013-250, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, 17504-072, Brazil
Hospital Universitário Onofre Lopes
Natal, 59012-300, Brazil
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060, Brazil
Facili Centro Integrado de Psiquiatria
São Bernardo do Campo, 09726-150, Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000, Brazil
CPCLIN
São Paulo, 01228-200, Brazil
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, 01236030, Brazil
A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
Valinhos, 13271-130, Brazil
Heritage Medical Research Clinic
Calgary, T2N 4Z6, Canada
Winterberry Research Inc.
Hamilton, L8J 0B6, Canada
Premier Clinical Trial Network
Hamilton, L8L 5G4, Canada
Alpha Recherche Clinique - Lévis
Lévis, G6V 0C9, Canada
Genge Partners
Montreal, H4A 3T2, Canada
Dar Clinical Research - Ottawa
Ottawa, K2J 3Z6, Canada
Centre de Recherche Saint-Louis inc.
Québec, G1W 4R4, Canada
Alpha Recherche Clinique
Québec, G2J 0C4, Canada
ALPHA Recherche Clinique
Québec, G3K 2P8, Canada
Richmond Clinical Trials
Richmond, V6V 2L1, Canada
Bluewater Clinical Research Group Inc.
Sarnia, N7T 4X3, Canada
Diex Recherche Sherbrooke
Sherbrooke, J1L 0H8, Canada
Centre for Neurology Studies
Surrey, V3V 0E8, Canada
Maple Leaf Research
Toronto, M5G 1K2, Canada
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, 100088, China
Beijing HuiLongGuan Hospital
Beijing, 100096, China
The Second People's Hospital of Hunan Province
Changsha, 410007, China
The Fourth People's Hospital of Chengdu
Chengdu, 610036, China
Guangzhou Brain Hospital
Guangzhou, 510370, China
Peking University Sixth Hospital
Haidian District, 100191, China
Hefei No.4 People's Hospital
Hefei, 230061, China
3rd People's Hospital of Huzhou
Huzhou, 313000, China
Shandong Daizhuang Hospital
Jining, 272051, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
The Affilicated Kangning Hospital of Ningbo University
Ningbo, 315201, China
Shanghai Mental Health Center
Shanghai, 200030, China
The First Hospital of Hebei Medical University
Shijiazhuang, 050031, China
Suzhou Guangji Hospital
Suzhou, 215003, China
Tianjin Anding Hospital
Tianjin, 300022, China
Renmin Hospital of Wuhan University
Wuhan, 430060, China
Wuxi Mental Health Center
Wuxi, 214151, China
Xi An Mental Health Center
Xi'an, 710061, China
Xianyang Hospital of Yan'an University
Xianyang, 712000, China
Zhumadian Psychiatric Hospital
Zhumadian, 463000, China
Universitätsklinikum Aachen
Aachen, 52074, Germany
FutureMeds GmbH
Berlin, 10629, Germany
Neurozentrum Bielefeld
Bielefeld, 33647, Germany
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, 09111, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, 55131, Germany
ISPG - Institut für Studien zur Psychischen Gesundheit
Mannheim, 68165, Germany
Somni bene
Schwerin, 19053, Germany
ZNS Siegen
Siegen, 57076, Germany
Argolida General Hospital
Argos, 212 00, Greece
Aiginiteio University Hospital
Athens, 115 28, Greece
Multidisciplinary Mental Health Hospital of Attiki
Athens, 124 62, Greece
Attikon General University Hospital
Chaïdári, 124 62, Greece
Multidisciplinary Mental Health Hospital of Thessaloniki
Stavroupoli, 564 29, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 564 29, Greece
General Hospital of Tripoli Panarkadiko Evangelistria
Tripoli, 221 00, Greece
Abe Clinic - Arakawa
Arakawa City, 116-0014, Japan
Uematsu Mental Clinic
Chikugo, 833-0041, Japan
Jimbocho Mental Clinic
Chiyoda City, 101-0051, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Kokorono Clinic Hirao
Fukuoka, 815-0071, Japan
Horikoshi Mental Somatic Clinic
Fukushima, 960-8053, Japan
University of the Ryukyus Hospital
Ginowan, 901-2725, Japan
Fujimidai Hospital
Hiratsuka, 259-1205, Japan
Rainbow and Sea Hospital
Karatsu, 847-0031, Japan
Kishiro Mental Clinic
Kawasaki, 214-0014, Japan
Monzen-nakacho Mental Clinic
Kōtō City, 135-0047, Japan
Yuge Hospital
Kumamoto, 861-8002, Japan
Suizenji Life Clinic
Kumamoto, 862-0956, Japan
Kure Medical Center
Kure, 737-0023, Japan
Hirota Clinic
Kurume, 830-0033, Japan
Senzoku Psychosomatic Medicine Clinic
Meguro-ku, 152-0012, Japan
Arata Clinic
Nagasaki, 852-8137, Japan
Yutaka Clinic
Sagamihara, 252-0303, Japan
Sangenjaya Shinkeika Shinryonaika Clinic
Setagaya City, 154-0004, Japan
Maynds Tower Mental Clinic
Shibuya-ku, 151-0053, Japan
Nanko Kokorono Clinic
Shirakawa, 961-0021, Japan
Sakurazaka Clinic SophyAnce
Tokyo, 106-0032, Japan
Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
Tokyo, 162-0843, Japan
Yamagata Sakuracho Hospital
Yamagata, 990-0045, Japan
Miki Mental Clinic
Yokohama, 220-0023, Japan
Shioiri Mental Clinic
Yokosuka, 238-0042, Japan
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, 44650, Mexico
B&B Investigaciones Medicas S.C.
Mazatlán, 82103, Mexico
Ketamine Clinic México
Mexico City, 04100, Mexico
GabiPros
Mexico City, 07000, Mexico
Medical Care and Research SA de CV
Mérida, 97070, Mexico
Centro de Investigacion Clinica Chapultepec
Morelia, 58260, Mexico
Arké SMO S.A de C.V
Veracruz, 91900, Mexico
Instituto Jalisciense de Salud Mental
Zapopan, 45170, Mexico
Podlaskie Centrum Psychogeriatrii
Bialystok, 15-756, Poland
MentalMEDIC
Bielsko-Biala, 43-300, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546, Poland
Diamond Clinic
Krakow, 31-559, Poland
NZOZ Psychiatrycznej Mentis
Leszno, 64-100, Poland
Centrum Medyczne Luxmed
Lublin, 20-109, Poland
Private Practice - Dr. Małgorzata Wojtanowska-Bogacka
Poznan, 60-192, Poland
Centrum Medyczne Euromedis
Szczecin, 70-111, Poland
Medical Concierge Centrum Medyczne
Warsaw, 02-798, Poland
Centrum Medyczne Ginemedica
Wroclaw, 50-414, Poland
Clinhouse Centrum Medyczne
Zabrze, 41-807, Poland
SCB Research Center
Bayamón, 00961, Puerto Rico
Korea University Ansan Hospital
Ansan-si, 15355, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Jeju National University Hospital
Jeju City, 63241, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003, Spain
Institucion Hosp Hestia Palau
Barcelona, 08025, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Centro de Atención Integral La Corredoria
Oviedo, 33011, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37005, Spain
Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
Vitoria-Gasteiz, 01009, Spain
Complejo Asistencial de Zamora
Zamora, 49021, Spain
Keelung Chang Gung Memorial Hospital
Keelung, 204, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Cheng Hsin General Hospital
Taipei, 112, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, 333, Taiwan
Edinburgh Royal Infirmary
Edinburgh, EH16 4SA, United Kingdom
Devon Partnership Trust
Exeter, EX2 5AF, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
The Maudsley Hospital
London, SE5 8AZ, United Kingdom
Clerkenwell Health - London - Welbeck Street
London, W1G 8DR, United Kingdom
Queen's Medical Centre, Nottingham University Hospitals
Nottingham, NG7 2UH, United Kingdom
Warneford Hospital
Oxford, OX3 7JX, United Kingdom
St Bartholomew's Medical Centre
Oxford, OX4 1XB, United Kingdom
Atlantic Medical
Penzance, TR18 3DX, United Kingdom
Woodstock Bower Surgery
Rotherham, S61 1AH, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2026
First Posted
February 17, 2026
Study Start
February 9, 2026
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
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.