🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT07286175
Recruiting Phase 2

A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

NCT07286175 · tracked via the Priya Life Science India tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2025-11-24
Last updated
2026-09-04

Condition(s) studied

Bipolar Disorder

Investigational drug(s) / intervention(s)

BrenipatidePlacebo

Brenipatide: Administered SC

Placebo: Administered SC

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (87)

FacilityCityRegionStatus
ATP Clinical Research Orange California Recruiting
Yale University School of Medicine New Haven Connecticut Recruiting
AGA Clinical Trials Hialeah Florida Recruiting
Accel Research Sites - Maitland Clinical Research Unit Maitland Florida Recruiting
K2 Medical Research - Maitland Maitland Florida Recruiting
Floridian Clinical Research, LLC Miami Lakes Florida Recruiting
CLA Research Naples Florida Recruiting
Charter Research - Orlando Orlando Florida Recruiting
Encore Medical Research - Weston Weston Florida Recruiting
Atlanta Center for Medical Research Atlanta Georgia Recruiting
Covenant Medical Center Waterloo Iowa Recruiting
CBH Health Gaithersburg Maryland Recruiting
Elixia MA Springfield Massachusetts Recruiting
Adams Clinical Watertown Watertown Massachusetts Recruiting
Penn Medicine: University of Pennsylvania Health System Philadelphia Pennsylvania Recruiting
Revival Research Institute, LLC McKinney Texas Recruiting
Pillar Clinical Research - Richardson Richardson Texas Recruiting
Alpine Research Organization Clinton Utah Recruiting
Re:Cognition Health Fairfax Virginia Recruiting
Northwest Clinical Research Center Bellevue Washington Recruiting
Hospital Italiano de Buenos Aires ABB Argentina Not Yet Recruiting
Centro Neurobiológico y de Estrés Traumático (CENydET) Buenos Aires Argentina Recruiting
Instituto Nacional de Psicopatología (INAPsi)- FunDaMos Buenos Aires Argentina Recruiting
Stat Research S.A. Buenos Aires Argentina Not Yet Recruiting
Mautalen Salud e Investigación Buenos Aires Argentina Recruiting
Instituto Médico DAMIC Córdoba Argentina Recruiting
Instituto Kremer Córdoba Argentina Recruiting
Centro Médico Luquez Córdoba Argentina Recruiting
Global Psy Asociación Civil La Plata Argentina Recruiting
Fundacion Scherbovsky Mendoza Argentina Recruiting
INECO Neurociencias Oroño Rosario Argentina Recruiting
Clinica El Jardin Santiago del Estero Argentina Recruiting
Chronos Pesquisa Clínica Brasília Brazil Recruiting
Instituto de Pesquisa clinica de Campinas Campinas Brazil Recruiting
Centro de Pesquisa Clínica de Marília - CPCLIM Marília Brazil Recruiting
Ruschel Medicina e Pesquisa Clínica Rio de Janeiro Brazil Not Yet Recruiting
Facili Centro Integrado de Psiquiatria São Bernardo do Campo Brazil Recruiting
CPQuali Pesquisa Clínica São Paulo Brazil Recruiting
BR Trials - Ensaios Clinicos e Consultoria São Paulo Brazil Recruiting
Clinica Viver - Centro de Desospitalizacao Humana São Paulo Brazil Recruiting

+ 47 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07286175 on ClinicalTrials.gov ↗ ← All trials in India