Under construction – not a live service
Sign in
Taking people in IndiaPhase 2

Tests brenipatide with usual care in adults with bipolar disorder

Tests whether brenipatide added to usual care delays bipolar symptoms returning in adults.

Key facts

Who runs it
Eli Lilly and Company
Where
Belgavi, Bhopal, Chhatrapati Sambhajinagar, Dehradun, Dharwad, Lucknow, Mysore, Nashik, Pune, Tiruchirappalli, and Varanasi, IndiaSee the 13 sitesAlso in 7 other countries, 74 sites
Trial code
Registry title
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
Status
Recruiting
Phase
Phase 2
People taking part
400 people, planned
Started
24 Nov 2025
Expected to end
Nov 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Brenipatide
  • Placebo
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with bipolar disorder type I or II who are on a stable standard medication. It tests brenipatide against placebo for delaying worsening of symptoms.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Bipolar disorder I or bipolar disorder II.
Earlier treatment
Must be on stable standard of care medication for bipolar disorder. Must not have received active treatment in another clinical study within 90 days or 5 half-lives (whichever is longer) before screening.

Main reasons for not taking part

  • Schizophrenia or another psychotic disorder, borderline personality disorder, or any eating disorder (lifetime or current)
  • Type 1 diabetes, or past ketoacidosis or hyperosmolar state or coma
  • Moderate or severe substance or alcohol use disorder within the past 180 days
  • Actively suicidal or at significant risk for suicide
  • Active treatment in another clinical study within 90 days or 5 half-lives before screening

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening
  • 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
  • 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
  • Are actively suicidal and or deemed to be at significant risk for suicide

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in India

Also in 7 other countries, 74 sites

  • Belagavi Institute of Medical Sciences - BelagaviBelgavi, IndiaContact: Chandra Shekhar TR (principal investigator)Taking people
  • All India Institute of Medical Sciences (AIIMS) - BhopalBhopal, IndiaContact: Tamonud Modak (principal investigator)Taking people
  • Galaxy Superspeciality HospitalChhatrapati Sambhajinagar, IndiaContact: Amol Deshmukh (principal investigator)Taking people
  • Society for Psychiatric Update and ResearchChhatrapati Sambhajinagar, IndiaContact: Chinmay Barhale (principal investigator)Taking people
  • Graphic Era Institute of Medical Sciences and HospitalDehradun, IndiaContact: Jeetpal Singh Rana (principal investigator)Not yet recruiting
  • Dharwad Institute Of Mental Health And NeurosciencesDharwad, IndiaContact: Srinivas Kosgi (principal investigator)Taking people
  • Career Institute of Medical Sciences and Hospital - LucknowLucknow, IndiaContact: Abbas Mehdi (principal investigator)Taking people
  • Dr Ram Manohar Lohia Institute of Medical SciencesLucknow, IndiaContact: Abdul Qadir Jilani (principal investigator)Taking people
  • Mysore Medical CollegeMysore, IndiaContact: Narendra M.S. (principal investigator)Taking people
  • Assured Care Plus HospitalNashik, IndiaContact: Nakul Vanjari (principal investigator)Taking people
  • Lifepoint Multispeciality HospitalPune, IndiaContact: Nitin Dalaya (principal investigator)Taking people
  • Sowmanasya Hospital and Institute of PsychiatryTiruchirappalli, IndiaContact: Gopalakrishnan Ganesan (principal investigator)Not yet recruiting
  • Deva Institute Of Healthcare ResearchVaranasi, IndiaContact: Venu Jhanwar (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Brenipatide Dose 1Treatment being tested

    Brenipatide administered subcutaneous (SC) + SoC.

    Treatment: Brenipatide

  • Brenipatide Dose 2 .Treatment being tested

    Brenipatide administered subcutaneous (SC) + SoC.

    Treatment: Brenipatide

  • PlaceboPlacebo, for comparison

    Placebo administered SC + SoC.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 2, 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 Bipolar Disorder (RENEW-Bipolar-1)
Plain-language title
Tests brenipatide with usual care in adults with bipolar disorderGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07286175, who can take part
Record updated
4 November 2026