CTRI

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CTRI Number

CTRI/2026/04/109019 [Registered on: 21/04/2026] Trial Registered Prospectively

Last Modified On:

24/08/2026

Post Graduate Thesis

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 Adult Patients With Schizophrenia

Scientific Title of Study

A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1)

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NCT07410507	ClinicalTrials.gov
Protocol no.: J2S-MC-GZMK amendment no. (a) dated 23OCT2025	Protocol Number
Protocol no.: J2S-MC-GZMK amendment no. (b) dated 17Dec2025	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

Name	Address
NIL	NIL

Countries of Recruitment

Argentina
Brazil
China
India
Japan
Taiwan
United States of America

Sites of Study
Modification(s)

No of Sites = 13
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, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh-462020. Bhopal MADHYA PRADESH	9971384346 tamonud.psy@aiimsbhopal.edu.in
Dr Prashant Laxmanrao Dasud	Calida Psychiatric Hospital	Department of Psychiatry, Rehab 55/1/A, Tata Road, Village Bhaliwadi, Post Gaulwadi, Karjat Rajgad, Maharashtra, India, 410201 Raigarh MAHARASHTRA	9764044079 prashantdasud@gmail.com
Dr Abbas Mehdi	Career Institute of Medical Sciences and Hospital – Lucknow	Near Shalimar Apartment, IIM Road, Lucknow, Ghaila, Uttar Pradesh, India, 226013. Lucknow UTTAR PRADESH	9451063244 mehdidrabbas@gmail.com
Dr Srinivas Kosgi	Dharwad Institute of Mental Health and Neurosciences, Dharwad	Dharwad-Belgaum Road, Saidapur, Dharwad, Karnataka, India, 580008. Belgaum KARNATAKA	9886933827 kosgi1974@gmail.com
Dr Chetan Dilip Vispute	Dr. D. Y Patil Medical College, Hospital & Research Centre	Sector -5, Nerul, Navi Mumbai, 400706, Maharashtra, India. Mumbai MAHARASHTRA	7021553187 visputechetan6@gmail.com
Dr Abdul Qadir Jilani	Dr. Ram Manohar Lohia Institute of Medical Sciences	Near Vibhuti Khand, Gomti Nagar, Lucknow, Uttar Pradesh, India, 226010. Lucknow UTTAR PRADESH	7007590702 drjilani19@gmail.com
Dr Deshmukh Amol Ashok	Galaxy Superspeciality Hospital & Research Institute	Agnihotra Chowk, Ulkanagari, Aurangabad, Maharashtra, India, 431001. Aurangabad MAHARASHTRA	9822314268 dr.amoldeshmukh.galaxy@gmail.com
Dr Jeetpal Singh Rana	Graphic Era Hospital	16th Milestone, Chakrata Road, Dehradun, Uttarakhand-248007 India. Dehradun UTTARANCHAL	8979390757 jeetpal65@gmail.com
Dr Nitin Veersingh Dalaya	Lifepoint Multispeciality Hospital	Sr. No. 145/1, Mumbai Banglore Highway, Near Hotel Sayaji, Wakad, Pune, Maharashtra, India, 411057. Pune MAHARASHTRA	9552503201 drndalaya@gmail.com
Dr Bhalchandra Kalmegh	Medipoint Hospitals Pvt. Ltd.	241/1, New D. P. Road, Aundh, Pune, Maharashtra, India, 411007. Pune MAHARASHTRA	8888108850 drbhalchandraclinicaltrials@gmail.com
Dr Saravana Jothi Ramalingam	Rajiv Gandhi Government General Hospital	Grand Southern Trunk Road, Near Park Town, Near Chennai Central, Park Town, Chennai, Tamil Nadu, India, 600003. Chennai TAMIL NADU	9841366985 drsaravanajothi.rgghcr@gmail.com
Dr Shreyansh Tatyasaheb Patil	Shree Mahalaxmi Diatone Institute	Department of Psychiatry, 511 Kh 1/A, E Ward, Behind LIC Office / Ingale Sadi Center, Station Road, Kolhapur, Maharashtra, India, 416001 Kolhapur MAHARASHTRA	9590089008 shreyanspatil@gmail.com
Dr Gopalakrishnan Ganesan	Sowmanasya Hospital and Institute of Psychiatry	Department of Psychiatry, No. 6, V N Nagar, Tiruchirapalli, Tamil Nadu, India, 620002 Tiruchirappalli TAMIL NADU	9443165625 drgopal.sowmanasya@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 13
Name of Committee	Approval Status
Aurangabad Health Care and Research LLP IEC	Approved
IEC Medical Care Centre and Hospital Medical Care Centre and Hospital	Approved
IEC-Calida Psychiatric Hospital-REHAB	Approved
Institutional Ethics Committee Dharwad Institute of Mental Health and Neuro Sciences (IEC DIMHANS), Dharwad Dharwad Institute of Mental Health &Neuro Sciences (DIMHANS)	Approved
Institutional Ethics Committee Digestive Disease Centre	Submittted/Under Review
Institutional Ethics Committee Dr. Ram Manohar Lohia Institute of Medical Sciences	Submittted/Under Review
Institutional Ethics Committee Harshamithra Oncology Pvt Ltd	Approved
Institutional Ethics Committee Hira Mongi Navneet Hospital Hira Mongi Navneet Hospital	Approved
Institutional Human Ethics Committee All India Institute of Medical Sciences	Submittted/Under Review
Kolhapur Cancer Centre Institutional Ethics Committee	Approved
LPR Ethics Committee Lifepoint Multispeciality Hospital	Approved
Madras Medical College	Submittted/Under Review
Pentamed Ethics Committee Medipoint Hospitals Pvt. Ltd	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: F20\|\|Schizophrenia,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Brenipatide	Administered subcutaneously throughout the treatment period for a maximum of 12 months
Comparator Agent	Placebo	Administered subcutaneously throughout the treatment period for a maximum of 12 months

Inclusion Criteria

Age From	18.00 Year(s)
Age To	55.00 Year(s)
Gender	Both
Details	1. Meet the diagnostic criteria of schizophrenia 2. Are on a stable standard of care medication regimen for schizophrenia 3. If the duration of illness is more than 6 years, participant has experienced at least one relapse of schizophrenia in last 3 years 4. Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse) 5. 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 study intervention as directed, - maintain electronic or paper study diaries, as applicable, and - complete the required questionnaires

ExclusionCriteria

Details

1. Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder
2. Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
3. Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma
4. Are actively suicidal or deemed to be a significant risk for suicide
5. Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

Method of Generating Random Sequence

Stratified randomization

Method of Concealment

Centralized

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index more than 25.0 Kilograms per Meter Squared (kg/m²)	Baseline, Week 52

Secondary Outcome

Outcome	TimePoints
Change from Baseline on Neurocognitive Battery Composite Test Score at Week 36	Baseline, Week 36
Time to Relapse	Randomization up to Week 52
Change from Baseline in Clinical Global Impression - Severity - Schizophrenia (CGI-S-SCH)	Baseline, Week 52
Change from Baseline in Patient Global Impression - Severity	Baseline, Week 52
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score	Baseline, Week 52
Change from Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Total Completion Time	Baseline, Week 52
Change from Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Total Score	Baseline, Week 52
Percentage of Participants with Body Mass Index more than 25 kg/m2 (BMI) Who Achieve Body Weight Reduction of more than 5%	Baseline, Week 52
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide	Baseline, Week 52
Number of Participants with Treatment-Emergent Anti-Drug Antibodies	Baseline, Week 52

Target Sample Size

Total Sample Size="450"
Sample Size from India="110"
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)

16/05/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

10/02/2026

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="14"

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 10-02-2026 and end date provided 30-11-2028?
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 to placebo plus SoC for treatment of schizophrenia.

The trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.