Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT07412756

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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A Study of Brenipatide in Adult Participants With Major Depressive Disorder | DecenTrialz