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CTRI Number  CTRI/2026/03/107152 [Registered on: 30/03/2026] Trial Registered Prospectively
Last Modified On: 26/03/2026
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 Adult With Asthma 
Scientific Title of Study   A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared with Placebo for the Treatment of Adult Participants with Uncontrolled Moderate to Severe Asthma 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT07219173  ClinicalTrials.gov 
Protocol no.: J2S-MC-GZMR version no. a dated 01-AUG-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  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Brazil
Canada
China
France
Germany
India
Japan
Mexico
Netherlands
Poland
United States of America  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akshay Budhraja  Aakash Healthcare Super Speciality Hospital   Hospital Plot, Road Number 201, Dwarka Sector-3, Ground floor, Dwarka, Delhi, 110075, India.
New Delhi
DELHI 		 9893322007

drakshay.budhraja@aakashhealthcare.com  
Dr Dibakar Sahu  All India Institute of Medical Sciences  Great Eastern Road, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh, 492099, India.
Raipur
CHHATTISGARH 		 8059753143

dibakarsahu@aiimsraipur.edu.in 
Dr Mahismita Patro   All India Institute of Medical Sciences  Sijua, Patrapada, Bhubaneswar, Odisha, 751019, India.
Khordha
ORISSA 		 8763345416

mahismita.patro@gmail.com 
Dr Saurabh Mittal  All India Institute of Medical Sciences  Department of Pulmonary, Critical Care and Sleep Medicine, Ansari Nagar, New Delhi, India, 110029.
New Delhi
DELHI 		 9999144116

saurabh_kgmu@yahoo.co.in  
Dr Arjun Bhatnagar  Atmaram Child Care and Critical Care   53/128, Y Block, Naubasta, Kanpur, Uttar Pradesh, 208011, India.
Kanpur Nagar
UTTAR PRADESH 		 9450688487

drarjunbhatnagarres@gmail.com 
Dr Bardapurkar Shreehas Suhas  Galaxy Superspeciality Hospital, & Research Institute   Galaxy Superspeciality Hospital, & Research Institute, Agnihotra Chowk, Ulkanagari, Aurangabad, Maharashtra 431001, India.
Aurangabad
MAHARASHTRA 		 9405912791

dr.shreehas.pulmo@gmail.com 
Dr Rajkumar Nikalje   Lifepoint Multispeciality Hospital   Sr. No. 145/1 Mumbai, Bangalore Highway, Near Hotel Sayaji, Wakad, Pune, 411057, Maharashtra, India.
Pune
MAHARASHTRA 		 9028560535

nikaljeraj80@gmail.com 
Dr Hafiz Mohd Deshmukh  Mahatma Gandhi Mission Medical College and Hospital   Department of Pulmonary, MGM Medical College and Hospital, N-6 CIDCO, Chhatrapati Sambhajinagar (Aurangabad)-431003, Maharashtra, India.
Aurangabad
MAHARASHTRA 		 8390628800

dr.hafiz.deshmukh@gmail.com  
Dr Hirennappa B Udnur   Medstar Speciality Hospital  #641/17/1/3, Kodegehalli Main Road, Sahakarnagar, Bangalore, 560092, Karnataka, India.
Bangalore
KARNATAKA 		 9379246563

drhirennappa.medstar@gmail.com 
Dr Aman Ahuja  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences   Rohtak, 124001, Haryana, India.
Rohtak
HARYANA 		 8290470844

aman2027@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Aakash Healthcare Super Specialty Hospital Institutional Ethics Committee   Approved 
Aurangabad Health Care and Research LLP IEC  Approved 
Ethics Committee Atmaram Child Care and Critical Care  Submittted/Under Review 
Institute Ethics Committee, AIIMS Raipur   Submittted/Under Review 
Institute Ethics Committee, All India Institute of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee, Faculty Research, AIIMS Bhubaneswar   Submittted/Under Review 
LPR Ethics Committee   Approved 
Mahatma Gandhi Mission Ethics Committee for Research on Human Subjects (MGM- ECRHS)   Submittted/Under Review 
Medstar Speciality Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J455||Severe persistent asthma, (2) ICD-10 Condition: J454||Moderate persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brenipatide  Brenipatide administered subcutaneously (SC) throughout treatment period. The trial will run for approximately 65 weeks.  
Comparator Agent  Placebo  Placebo administered subcutaneously (SC) throughout treatment period. The trial will run for approximately 65 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Physician-diagnosed asthma who have received a physician-prescribed asthma controller medication for at least 12 months prior to screening visit.
2. Participants must have an asthma control questionnaire-6 (ACQ-6) score of equal to or more than 1.5 on 2 out of 3 visits before randomization.
3. History of 1 severe asthma exacerbation that led to systemic glucocorticoid treatment in the last 12 months prior to screening visit. 
 
ExclusionCriteria 
Details  1. Participants are excluded from the study if any of the following criteria apply:
- An established diagnosis of occupational asthma

2. Known pre-existing, clinically important lung condition other than asthma, including but not limited to:
- chronic respiratory infection
- bronchiectasis
- pulmonary fibrosis
- allergic bronchopulmonary aspergillosis
- emphysema
- chronic bronchitis
- eosinophilic granulomatosis with polyangiitis
- chronic obstructive pulmonary disease, and
- other mimics of asthma, that is, vocal cord dysfunction.

3. Have a current or recent acute, active infection. For at least 30 days before screening visit and up to the randomization visit. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment
 		 Baseline to Week 52 
 
Secondary Outcome  
Outcome  TimePoints 
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1)  Baseline, Week 52 
Change from Baseline in Patient Reported Health Outcomes  Baseline, Week 52 
Time to First Exacerbation  Baseline to Week 52 
Change from Baseline in Weekly Mean Rescue Medication Use  Baseline, Week 52 
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide  Baseline up to Week 52 
Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)  Baseline to Week 52 
 
Target Sample Size   Total Sample Size="531"
Sample Size from India="80" 
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)   08/05/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  22/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="1"
Days="22" 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  www.vivli.org

  6. For how long will this data be available start date provided 08-05-2026 and end date provided 30-06-2028?
    Response (Others) -  Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

  7. 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 safety and efficacy of brenipatide at different dose levels compared with placebo in participants with moderate-to-severe asthma.

Study participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.

 
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