Actively Recruiting
A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Led by Eli Lilly and Company · Updated on 2026-03-23
1000
Participants Needed
186
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 be available for the study duration and attend required visits
- Are willing and able to perform study procedures including self-injecting the study drug
- Can store and use the blinded study intervention as directed
- Can maintain electronic and paper study diaries if applicable
- Can complete required questionnaires
You will not qualify if you...
- Have a lifetime or current diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, borderline personality disorder, or any eating disorder
- Have type 1 diabetes mellitus or a history of ketoacidosis or hyperosmolar state or coma
- Have moderate or severe substance or alcohol use disorder within 180 days before screening
- Are actively suicidal or considered at significant risk for suicide
- Have participated in a clinical study and received active treatment or unknown treatment within 90 days or 5 half-lives before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 186 locations
1
Accellacare - Moorpark
Moorpark, California, United States, 93021
Not Yet Recruiting
2
ATP Clinical Research
Orange, California, United States, 92866
Actively Recruiting
3
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Not Yet Recruiting
4
Encore Medical Research
Hollywood, Florida, United States, 33024
Not Yet Recruiting
5
K2 Medical Research - Maitland
Maitland, Florida, United States, 32751
Not Yet Recruiting
6
Life Medical Research Group Corp
Miami Gardens, Florida, United States, 33014
Actively Recruiting
7
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States, 33016-1518
Not Yet Recruiting
8
CLA Research
Naples, Florida, United States, 34116
Not Yet Recruiting
9
Optimal Research Sites
Orange City, Florida, United States, 32763
Actively Recruiting
10
Charter Research - Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
11
K2 Medical Research - Tampa
Tampa, Florida, United States, 33634
Not Yet Recruiting
12
CenExel iResearch, LLC
Decatur, Georgia, United States, 30030
Actively Recruiting
13
Indiana University Health Neuroscience Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
14
Cedar Valley Medical Specialists
Waterloo, Iowa, United States, 50701
Not Yet Recruiting
15
Pharmasite Research, Inc.
Baltimore, Maryland, United States, 21208
Actively Recruiting
16
Adams Clinical Boston
Boston, Massachusetts, United States, 02116
Actively Recruiting
17
Adams Clinical Watertown
Watertown, Massachusetts, United States, 02472
Actively Recruiting
18
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States, 48098
Not Yet Recruiting
19
Arch Clinical Trials
St Louis, Missouri, United States, 63141
Not Yet Recruiting
20
Vector Clinical Trials
Las Vegas, Nevada, United States, 89128
Actively Recruiting
21
Adams Clinical Harlem
New York, New York, United States, 10029
Actively Recruiting
22
Summit Headlands
Portland, Oregon, United States, 97210
Not Yet Recruiting
23
Suburban Research Associates
Media, Pennsylvania, United States, 19063
Actively Recruiting
24
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
25
K2 Medical Research - East Providence
East Providence, Rhode Island, United States, 02914
Not Yet Recruiting
26
Circle Clinical Research
Sioux Falls, South Dakota, United States, 57104
Not Yet Recruiting
27
Adams Clinical Dallas
DeSoto, Texas, United States, 75115
Actively Recruiting
28
Re:Cognition Health - Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
29
Consano Clinical Research, LLC
Shavano Park, Texas, United States, 78231
Not Yet Recruiting
30
Alpine Research Organization
Clinton, Utah, United States, 84015
Actively Recruiting
31
Re:Cognition Health
Fairfax, Virginia, United States, 22031
Not Yet Recruiting
32
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Actively Recruiting
33
Mater Misericordiae Limited
Brisbane, Australia, 4101
Not Yet Recruiting
34
NeuroCentrix
Carlton, Australia, 3053
Not Yet Recruiting
35
Lyell McEwin Hospital
Elizabeth Vale, Australia, 5112
Not Yet Recruiting
36
Barwon Health
Geelong, Australia, 3220
Not Yet Recruiting
37
Multidisciplinary Alfred Psychiatry Research Centre
Melbourne, Australia, 3004
Not Yet Recruiting
38
Paratus Clinical Research - Melbourne
Melbourne, Australia, 3070
Not Yet Recruiting
39
Mildura Base Hospital
Mildura, Australia, 3500
Not Yet Recruiting
40
Toowoomba Hospital
Toowoomba, Australia, 4350
Not Yet Recruiting
41
Innovate Clinical Research
Waitara, Australia, 2077
Not Yet Recruiting
42
Westmead Hospital
Westmead, Australia, 2145
Not Yet Recruiting
43
Hospital das Clínicas da UFMG
Belo Horizonte, Brazil, 30130-100
Not Yet Recruiting
44
Trial Tech
Curitiba, Brazil, 80240-280
Not Yet Recruiting
45
Clinilive
Maringá, Brazil, 87013-250
Not Yet Recruiting
46
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, Brazil, 17504-072
Not Yet Recruiting
47
Hospital Universitário Onofre Lopes
Natal, Brazil, 59012-300
Not Yet Recruiting
48
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, Brazil, 22270-060
Not Yet Recruiting
49
Facili Centro Integrado de Psiquiatria
São Bernardo do Campo, Brazil, 09726-150
Not Yet Recruiting
50
CPQuali Pesquisa Clínica
São Paulo, Brazil, 01228-000
Not Yet Recruiting
51
CPCLIN
São Paulo, Brazil, 01228-200
Not Yet Recruiting
52
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, Brazil, 01236030
Not Yet Recruiting
53
A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
Valinhos, Brazil, 13271-130
Not Yet Recruiting
54
Heritage Medical Research Clinic
Calgary, Canada, T2N 4Z6
Not Yet Recruiting
55
Winterberry Research Inc.
Hamilton, Canada, L8J 0B6
Not Yet Recruiting
56
Premier Clinical Trial Network
Hamilton, Canada, L8L 5G4
Not Yet Recruiting
57
Alpha Recherche Clinique - Lévis
Lévis, Canada, G6V 0C9
Not Yet Recruiting
58
Genge Partners
Montreal, Canada, H4A 3T2
Not Yet Recruiting
59
Dar Clinical Research - Ottawa
Ottawa, Canada, K2J 3Z6
Not Yet Recruiting
60
Centre de Recherche Saint-Louis inc.
Québec, Canada, G1W 4R4
Not Yet Recruiting
61
Alpha Recherche Clinique
Québec, Canada, G2J 0C4
Not Yet Recruiting
62
ALPHA Recherche Clinique
Québec, Canada, G3K 2P8
Not Yet Recruiting
63
Richmond Clinical Trials
Richmond, Canada, V6V 2L1
Not Yet Recruiting
64
Bluewater Clinical Research Group Inc.
Sarnia, Canada, N7T 4X3
Not Yet Recruiting
65
Diex Recherche Sherbrooke
Sherbrooke, Canada, J1L 0H8
Not Yet Recruiting
66
Centre for Neurology Studies
Surrey, Canada, V3V 0E8
Not Yet Recruiting
67
Maple Leaf Research
Toronto, Canada, M5G 1K2
Not Yet Recruiting
68
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, China, 100088
Not Yet Recruiting
69
Beijing HuiLongGuan Hospital
Beijing, China, 100096
Not Yet Recruiting
70
The Second People's Hospital of Hunan Province
Changsha, China, 410007
Not Yet Recruiting
71
The Fourth People's Hospital of Chengdu
Chengdu, China, 610036
Not Yet Recruiting
72
Guangzhou Brain Hospital
Guangzhou, China, 510370
Not Yet Recruiting
73
Peking University Sixth Hospital
Haidian District, China, 100191
Not Yet Recruiting
74
Hefei No.4 People's Hospital
Hefei, China, 230061
Not Yet Recruiting
75
3rd People's Hospital of Huzhou
Huzhou, China, 313000
Not Yet Recruiting
76
Shandong Daizhuang Hospital
Jining, China, 272051
Not Yet Recruiting
77
The First Affiliated Hospital of Nanchang University
Nanchang, China, 330006
Not Yet Recruiting
78
The Affilicated Kangning Hospital of Ningbo University
Ningbo, China, 315201
Not Yet Recruiting
79
Shanghai Mental Health Center
Shanghai, China, 200030
Not Yet Recruiting
80
The First Hospital of Hebei Medical University
Shijiazhuang, China, 050031
Not Yet Recruiting
81
Suzhou Guangji Hospital
Suzhou, China, 215003
Not Yet Recruiting
82
Tianjin Anding Hospital
Tianjin, China, 300022
Not Yet Recruiting
83
Renmin Hospital of Wuhan University
Wuhan, China, 430060
Not Yet Recruiting
84
Wuxi Mental Health Center
Wuxi, China, 214151
Not Yet Recruiting
85
Xi An Mental Health Center
Xi'an, China, 710061
Not Yet Recruiting
86
Xianyang Hospital of Yan'an University
Xianyang, China, 712000
Not Yet Recruiting
87
Zhumadian Psychiatric Hospital
Zhumadian, China, 463000
Not Yet Recruiting
88
Universitätsklinikum Aachen
Aachen, Germany, 52074
Not Yet Recruiting
89
FutureMeds GmbH
Berlin, Germany, 10629
Not Yet Recruiting
90
Neurozentrum Bielefeld
Bielefeld, Germany, 33647
Not Yet Recruiting
91
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, Germany, 09111
Not Yet Recruiting
92
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Germany, 55131
Not Yet Recruiting
93
ISPG - Institut für Studien zur Psychischen Gesundheit
Mannheim, Germany, 68165
Not Yet Recruiting
94
Somni bene
Schwerin, Germany, 19053
Not Yet Recruiting
95
ZNS Siegen
Siegen, Germany, 57076
Not Yet Recruiting
96
Argolida General Hospital
Argos, Greece, 212 00
Not Yet Recruiting
97
Aiginiteio University Hospital
Athens, Greece, 115 28
Not Yet Recruiting
98
Multidisciplinary Mental Health Hospital of Attiki
Athens, Greece, 124 62
Not Yet Recruiting
99
Attikon General University Hospital
Chaïdári, Greece, 124 62
Not Yet Recruiting
100
Multidisciplinary Mental Health Hospital of Thessaloniki
Stavroupoli, Greece, 564 29
Not Yet Recruiting
101
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Greece, 564 29
Not Yet Recruiting
102
General Hospital of Tripoli Panarkadiko Evangelistria
Tripoli, Greece, 221 00
Not Yet Recruiting
103
Abe Clinic - Arakawa
Arakawa City, Japan, 116-0014
Not Yet Recruiting
104
Uematsu Mental Clinic
Chikugo, Japan, 833-0041
Not Yet Recruiting
105
Jimbocho Mental Clinic
Chiyoda City, Japan, 101-0051
Not Yet Recruiting
106
Fukuoka University Hospital
Fukuoka, Japan, 814-0180
Not Yet Recruiting
107
Kokorono Clinic Hirao
Fukuoka, Japan, 815-0071
Not Yet Recruiting
108
Horikoshi Mental Somatic Clinic
Fukushima, Japan, 960-8053
Not Yet Recruiting
109
University of the Ryukyus Hospital
Ginowan, Japan, 901-2725
Not Yet Recruiting
110
Fujimidai Hospital
Hiratsuka, Japan, 259-1205
Not Yet Recruiting
111
Rainbow and Sea Hospital
Karatsu, Japan, 847-0031
Not Yet Recruiting
112
Kishiro Mental Clinic
Kawasaki, Japan, 214-0014
Not Yet Recruiting
113
Monzen-nakacho Mental Clinic
Kōtō City, Japan, 135-0047
Not Yet Recruiting
114
Yuge Hospital
Kumamoto, Japan, 861-8002
Not Yet Recruiting
115
Suizenji Life Clinic
Kumamoto, Japan, 862-0956
Not Yet Recruiting
116
Kure Medical Center
Kure, Japan, 737-0023
Not Yet Recruiting
117
Hirota Clinic
Kurume, Japan, 830-0033
Not Yet Recruiting
118
Senzoku Psychosomatic Medicine Clinic
Meguro-ku, Japan, 152-0012
Not Yet Recruiting
119
Arata Clinic
Nagasaki, Japan, 852-8137
Not Yet Recruiting
120
Yutaka Clinic
Sagamihara, Japan, 252-0303
Not Yet Recruiting
121
Sangenjaya Shinkeika Shinryonaika Clinic
Setagaya City, Japan, 154-0004
Not Yet Recruiting
122
Maynds Tower Mental Clinic
Shibuya-ku, Japan, 151-0053
Not Yet Recruiting
123
Nanko Kokorono Clinic
Shirakawa, Japan, 961-0021
Not Yet Recruiting
124
Sakurazaka Clinic SophyAnce
Tokyo, Japan, 106-0032
Not Yet Recruiting
125
Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
Tokyo, Japan, 162-0843
Not Yet Recruiting
126
Yamagata Sakuracho Hospital
Yamagata, Japan, 990-0045
Not Yet Recruiting
127
Miki Mental Clinic
Yokohama, Japan, 220-0023
Not Yet Recruiting
128
Shioiri Mental Clinic
Yokosuka, Japan, 238-0042
Not Yet Recruiting
129
Scientia Investigacion Clinica S.C.
Chihuahua City, Mexico, 31207
Not Yet Recruiting
130
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Mexico, 44650
Not Yet Recruiting
131
B&B Investigaciones Medicas S.C.
Mazatlán, Mexico, 82103
Not Yet Recruiting
132
Ketamine Clinic México
Mexico City, Mexico, 04100
Not Yet Recruiting
133
GabiPros
Mexico City, Mexico, 07000
Not Yet Recruiting
134
Medical Care and Research SA de CV
Mérida, Mexico, 97070
Not Yet Recruiting
135
Centro de Investigacion Clinica Chapultepec
Morelia, Mexico, 58260
Not Yet Recruiting
136
Arké SMO S.A de C.V
Veracruz, Mexico, 91900
Not Yet Recruiting
137
Instituto Jalisciense de Salud Mental
Zapopan, Mexico, 45170
Not Yet Recruiting
138
Podlaskie Centrum Psychogeriatrii
Bialystok, Poland, 15-756
Not Yet Recruiting
139
MentalMEDIC
Bielsko-Biala, Poland, 43-300
Not Yet Recruiting
140
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Poland, 80-546
Not Yet Recruiting
141
Diamond Clinic
Krakow, Poland, 31-559
Not Yet Recruiting
142
NZOZ Psychiatrycznej Mentis
Leszno, Poland, 64-100
Not Yet Recruiting
143
Centrum Medyczne Luxmed
Lublin, Poland, 20-109
Not Yet Recruiting
144
Private Practice - Dr. Małgorzata Wojtanowska-Bogacka
Poznan, Poland, 60-192
Not Yet Recruiting
145
Centrum Medyczne Euromedis
Szczecin, Poland, 70-111
Not Yet Recruiting
146
Medical Concierge Centrum Medyczne
Warsaw, Poland, 02-798
Not Yet Recruiting
147
Centrum Medyczne Ginemedica
Wroclaw, Poland, 50-414
Not Yet Recruiting
148
Clinhouse Centrum Medyczne
Zabrze, Poland, 41-807
Not Yet Recruiting
149
SCB Research Center
Bayamón, Puerto Rico, 00961
Not Yet Recruiting
150
Korea University Ansan Hospital
Ansan-si, South Korea, 15355
Not Yet Recruiting
151
Chonnam National University Hospital
Gwangju, South Korea, 61469
Not Yet Recruiting
152
Jeju National University Hospital
Jeju City, South Korea, 63241
Not Yet Recruiting
153
Seoul National University Hospital
Seoul, South Korea, 03080
Not Yet Recruiting
154
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Not Yet Recruiting
155
Konkuk University Medical Center
Seoul, South Korea, 05030
Not Yet Recruiting
156
Asan Medical Center
Seoul, South Korea, 05505
Not Yet Recruiting
157
Samsung Medical Center
Seoul, South Korea, 06351
Not Yet Recruiting
158
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Not Yet Recruiting
159
Parc de Salut Mar - Hospital del Mar
Barcelona, Spain, 08003
Not Yet Recruiting
160
Institucion Hosp Hestia Palau
Barcelona, Spain, 08025
Not Yet Recruiting
161
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Not Yet Recruiting
162
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Not Yet Recruiting
163
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Not Yet Recruiting
164
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Not Yet Recruiting
165
Centro de Atención Integral La Corredoria
Oviedo, Spain, 33011
Not Yet Recruiting
166
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, Spain, 37005
Not Yet Recruiting
167
Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
Vitoria-Gasteiz, Spain, 01009
Not Yet Recruiting
168
Complejo Asistencial de Zamora
Zamora, Spain, 49021
Not Yet Recruiting
169
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan, 204
Not Yet Recruiting
170
Chung Shan Medical University Hospital
Taichung, Taiwan, 402
Not Yet Recruiting
171
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Not Yet Recruiting
172
National Taiwan University Hospital
Taipei, Taiwan, 10002
Not Yet Recruiting
173
Taipei Medical University Hospital
Taipei, Taiwan, 110
Not Yet Recruiting
174
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Not Yet Recruiting
175
Cheng Hsin General Hospital
Taipei, Taiwan, 112
Not Yet Recruiting
176
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Not Yet Recruiting
177
Edinburgh Royal Infirmary
Edinburgh, United Kingdom, EH16 4SA
Not Yet Recruiting
178
Devon Partnership Trust
Exeter, United Kingdom, EX2 5AF
Not Yet Recruiting
179
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Not Yet Recruiting
180
The Maudsley Hospital
London, United Kingdom, SE5 8AZ
Not Yet Recruiting
181
Clerkenwell Health - London - Welbeck Street
London, United Kingdom, W1G 8DR
Not Yet Recruiting
182
Queen's Medical Centre, Nottingham University Hospitals
Nottingham, United Kingdom, NG7 2UH
Not Yet Recruiting
183
Warneford Hospital
Oxford, United Kingdom, OX3 7JX
Not Yet Recruiting
184
St Bartholomew's Medical Centre
Oxford, United Kingdom, OX4 1XB
Not Yet Recruiting
185
Atlantic Medical
Penzance, United Kingdom, TR18 3DX
Not Yet Recruiting
186
Woodstock Bower Surgery
Rotherham, United Kingdom, S61 1AH
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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