| CTRI Number |
CTRI/2026/03/106554 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study of Brenipatide in Adults with Bipolar Disorder |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT07286175 |
ClinicalTrials.gov |
| Protocol no. J2S-MC-GZMJ amendment no. (a) dated 23-Oct-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Kapur |
| Designation |
Medical Director |
| Affiliation |
Eli Lilly and Company (India) Pvt. Ltd |
| Address |
Plot No - 92, Sec - 32, Institutional Area, Gurgaon Haryana-122001 India
Gurgaon
HARYANA
122001
India |
| Phone |
9910932606 |
| Fax |
|
| Email |
rahul.kapur@lilly.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Kapur |
| Designation |
Medical Director |
| Affiliation |
Eli Lilly and Company (India) Pvt. Ltd |
| Address |
Plot No - 92, Sec - 32, Institutional Area, Gurgaon Haryana-122001 India
Gurgaon
HARYANA
122001
India |
| Phone |
9910932606 |
| Fax |
|
| Email |
rahul.kapur@lilly.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Sharan Shrivastava |
| Designation |
Associate Director |
| Affiliation |
Eli Lilly and Company (India) Pvt. Ltd |
| Address |
Plot No - 92, Sec - 32, Institutional Area, Gurgaon Haryana-122001 India
Gurgaon
HARYANA
122011
India |
| Phone |
09810308697 |
| Fax |
|
| Email |
shrivastava_rajeev_sharan@lilly.com |
|
|
Source of Monetary or Material Support
|
| Eli Lilly and Company (India) Pvt. Ltd., Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA-122001 India |
|
|
Primary Sponsor
|
| Name |
Eli Lilly and Company (India) Pvt Ltd |
| Address |
Plot No - 92, Sec - 32, Institutional Area, Gurgaon Haryana-122001 India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Brazil
China
India
Japan
Mexico
United States of America |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tamonud Modak |
All India Institute of Medical Sciences (AIIMS) - Bhopal |
AIIMS Campus Road, Bhopal, Madhya Pradesh, India, 462024
Bhopal
MADHYA PRADESH |
9971384346
tamonud.psy@aiimsbhopal.edu.in |
| Dr Nakul Ashok Vanjari |
Assured Care Plus Hospital |
Department of Psychiatry, Lam Road, 4th & 5th Floor, Star Plus Complex,, Near Muktidham Temple Nashik, Opp NMC Divisional Office, Nashik, Maharashtra, India, 422101
Nashik
MAHARASHTRA |
2532950011
nakulv1986@gmail.com |
| Dr Chandrashekar TR |
Belagavi Institute of Medical Science |
Belagavi Institute of Medical sciences, Dr B R Ambedkar Road, Belgavi, Karnataka, India, 590019
Belgaum
KARNATAKA |
9611427666
drtrcshekar007@gmail.com |
| Dr Abbas Mehdi |
Career Institute of Medical Sciences and Hospital – Lucknow |
Department of Psychiatry, IIM Road, Lucknow, Uttar Pradesh, India, 226020
Lucknow
UTTAR PRADESH |
9451063244
mehdidrabbas@gmail.com |
| Dr Venu Gopal Jhanwar |
Deva Institute of Healthcare & Research Pvt Ltd. |
Department of Psychiatry, Durgakund Road, B 27/70 MN Durgakund, Bhelupura, Varanasi, Uttar Pradesh, India, 221005
Varanasi
UTTAR PRADESH |
9935571052
vgj.dihr@gmail.com |
| Dr Abdul Qadir Jilani |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
Department of Psychiatry, Vibhuti Khand, Gomti Nagar, 3rd floor Cath Lab, Institution block, Lucknow, Uttar Pradesh, India, 226010
Lucknow
UTTAR PRADESH |
7007590702
drjilani19@gmail.com |
| Dr Deshmukh Amol Ashok |
Galaxy Superspeciality Hospital & Research Institute |
Department of Psychiatry, Agnihotra Chowk, Opposite Punjab National Bank, Aurangabad, Maharashtra, India, 431001
Aurangabad
MAHARASHTRA |
9822314268
dr.amoldeshmukh.galaxy@gmail.com |
| Dr Dalay Nitin Veersingh |
Lifepoint Multispeciality Hospital |
Clinical Research Department, 145/1 Mumbai Bangalore Highway, 3rd floor, Clinical Research Department,, Near Hotel Sayaji, Wakad, Pune,, Pune, Maharashtra, India, 411057
Pune
MAHARASHTRA |
9552503201
drndalaya@gmail.com |
| Dr Chinmay Vinay Barhale |
Society of Psychiatric Update & Research (SPUR) |
Shanti Nursing Home, Kanchan wadi, Paithan Road, 1st building, 1st floor, Room no. 214, Research department, Chhatrapati Sambhajinagar, Maharashtra, India, 431005
Aurangabad
MAHARASHTRA |
9823012123
drchinmay@shantinursinghome.com |
| Dr Gopalakrishnan Ganesan |
Sowmanasya Hospital and Institute of Psychiatry |
Department of Psychiatry, 6, V N Nagar, Tiruchirappalli, Tamil Nadu, India, 620002
Tiruchirappalli
TAMIL NADU |
9443165625
drgopal.sowmanasya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| DMHC Ethics Committee, Dcap 1st Floor, Deva Institute Of Healthcare Research Pvt. Ltd |
Submittted/Under Review |
| Ethics Committee Harshamitra Superspeciality Cancer Centre |
Submittted/Under Review |
| Ethics Committee Shanti Nursing Home |
Approved |
| IEC Medical Care Centre and Hospital Medical Care Centre and Hospital |
Submittted/Under Review |
| Independent Ethics Committee Aurangabad Health Care & Research LLP |
Submittted/Under Review |
| Institutional Ethics Committee Dr. Ram Manohar Lohia Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee, Assured Care Plus Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Belagavi Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Human Ethics Committee, All India Institute of Medical Sciences |
Submittted/Under Review |
| LPR Ethics Committee, Lifepoint Multispeciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F31||Bipolar disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brenipatide |
Administered subcutaneously (SC) for a treatment period that will last a minimum of 6 months |
| Comparator Agent |
Placebo |
Administered subcutaneously (SC) for a treatment period that will last a minimum of 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Meet the diagnostic criteria for bipolar disorder I or bipolar disorder II
2. 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
3. Are on stable standard of care medication for bipolar disorder |
|
| ExclusionCriteria |
| Details |
1. 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
2. Have type 1 diabetes mellitus, or a history of
- ketoacidosis, or
- hyperosmolar state or coma
3. Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening
4. Are actively suicidal and or deemed to be at significant risk for suicide
5. 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 |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion |
Randomization up to at least 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score |
Baseline, up to at least 6 months |
| Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score |
Baseline, up to at least 6 months |
| Change from Baseline in Young Mania Rating Scale (YMRS) Total Score |
Baseline, up to at least 6 months |
| Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score |
Baseline, up to at least 6 months |
| Mean Percent Change in Body Weight in Participants with a Baseline Body Mass Index (BMI) of more than or equal to 25 kg/m2 |
Baseline, up to at least 6 months |
| Mean Percent Change in Body Weight in Participants with a Baseline Body Mass Index (BMI) of more than or equal to 25 kg/m2 and on an Atypical Antipsychotic |
Baseline, up to at least 6 months |
| Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide |
Baseline, up to at least 6 months |
| Number of Participants with Treatment-Emergent Anti-Drug Antibodies |
Baseline, up to at least 6 months |
| Change from Baseline in Patient rated Outcome as measured by Patient Global Impression of Severity (PGI-S) |
Baseline, up to at least 6 months |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="29" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - www.vivli.org
- For how long will this data be available start date provided 24-11-2025 and end date provided 30-11-2027?
Response (Others) - Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief 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. |