A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
Recruiting · NCT07286175 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
BrenipatidePlacebo
What this trial is about
The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Meet the diagnostic criteria for bipolar disorder I or bipolar disorder II
- 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
- Are on stable standard of care medication for bipolar disorder
Exclusion criteria
- Have a lifetime history or current diagnosis of the following according to DSM-5 criteria:
- schizophrenia or other psychotic disorder
- borderline personality disorder, or
- any eating disorder
- Have type 1 diabetes mellitus, or a history of
- ketoacidosis, or
- hyperosmolar state or coma
- Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening
- Are actively suicidal and or deemed to be at 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
Where it is running
60 locations listed across 12 US states.
- ATP Clinical Research - Orange, California, United States
- Yale University School of Medicine - New Haven, Connecticut, United States
- AGA Clinical Trials - Hialeah, Florida, United States
- Accel Research Sites - Maitland Clinical Research Unit - Maitland, Florida, United States
- K2 Medical Research - Maitland - Maitland, Florida, United States
- Floridian Clinical Research, LLC - Miami Lakes, Florida, United States
- CLA Research - Naples, Florida, United States
- Charter Research - Orlando - Orlando, Florida, United States
- Encore Medical Research - Weston - Weston, Florida, United States
- Atlanta Center for Medical Research - Atlanta, Georgia, United States
- Covenant Medical Center - Waterloo, Iowa, United States
- CBH Health - Gaithersburg, Maryland, United States
- Elixia MA - Springfield, Massachusetts, United States
- Adams Clinical Watertown - Watertown, Massachusetts, United States
- Penn Medicine: University of Pennsylvania Health System - Philadelphia, Pennsylvania, United States
- Revival Research Institute, LLC - McKinney, Texas, United States
- Pillar Clinical Research - Richardson - Richardson, Texas, United States
- Alpine Research Organization - Clinton, Utah, United States
- Re:Cognition Health - Fairfax, Virginia, United States
- Northwest Clinical Research Center - Bellevue, Washington, United States
- Hospital Italiano de Buenos Aires - ABB, Argentina
- Galaxy Superspeciality Hospital - Aurangabad, India
- SCB Research Center - Bayamón, Puerto Rico
- Belagavi Institute of Medical Sciences - Belagavi - Belgavi, India
- All India Institute of Medical Sciences (AIIMS) - Bhopal - Bhopal, India
- Chronos Pesquisa Clínica - Brasília, Brazil
- Centro Neurobiológico y de Estrés Traumático (CENydET) - Buenos Aires, Argentina
- Instituto Nacional de Psicopatología (INAPsi)- FunDaMos - Buenos Aires, Argentina
- Stat Research S.A. - Buenos Aires, Argentina
- Mautalen Salud e Investigación - Buenos Aires, Argentina
- Instituto de Pesquisa clinica de Campinas - Campinas, Brazil
- The Second People's Hospital of Hunan Province - Changsha, China
- Society for Psychiatric Update and Research - Chhatrapati Sambhajinagar, India
- Scientia Investigacion Clinica S.C. - Chihuahua City, Mexico
- Uematsu Mental Clinic - Chikugo, Japan
- Jimbocho Mental Clinic - Chiyoda City, Japan
- Instituto Médico DAMIC - Córdoba, Argentina
- Instituto Kremer - Córdoba, Argentina
- Centro Médico Luquez - Córdoba, Argentina
- Graphic Era Institute of Medical Sciences and Hospital - Dehradun, India
- Dharwad Institute Of Mental Health And Neurosciences - Dharwad, India
- Horikoshi Mental Somatic Clinic - Fukushima, Japan
- Clinica de Investigacion en Reumatologia y Obesidad S. C. - Guadalajara, Mexico
- The Seventh People's Hospital of Hangzhou - Hangzhou, China
- 3rd People's Hospital of Huzhou - Huzhou, China
- Saitama Medical University Hospital - Iruma, Japan
- Shangdong Mental Health Center - Jinan, China
- Rainbow and Sea Hospital - Karatsu, Japan
- Suizenji Life Clinic - Kumamoto, Japan
- Kure Medical Center - Kure, Japan
- Hirota Clinic - Kurume, Japan
- Monzen-nakacho Mental Clinic - Kōtō City, Japan
- Global Psy Asociación Civil - La Plata, Argentina
- Dr. Ram Manohar Lohia Institute of Medical Sciences - Lucknow, India
- Career Institute of Medical Sciences and Hospital - Lucknow - Lucknow, India
- Centro de Pesquisa Clínica de Marília - CPCLIM - Marília, Brazil
- B&B Investigaciones Medicas S.C. - Mazatlán, Mexico
- Fundacion Scherbovsky - Mendoza, Argentina
- Centro de Investigación Clinica Chapultepec - Mexico City, Mexico
- Ketamine Clinic México - Mexico City, Mexico
Showing 60 of 87 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →