| CTRI Number |
CTRI/2026/04/107819 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/09/2026 |
| 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 a Once-Daily Tablet (Orforglipron) to Improve Blood Flow in People with Peripheral Artery Disease |
|
Scientific Title of Study
|
A Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants with Peripheral Artery Disease: A Randomized, Double-Blind, Placebo-Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol no. J2A-MC-GZPR, Initial protocol dated 07Aug2025 |
Protocol Number |
| NCT07223593 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Kapur |
| Designation |
Senior Director - Medical (India) |
| 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 |
Senior Director - Medical (India) |
| 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 |
Director - Regulatory Affairs and Pharmacovigilance (India) |
| 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 |
9810308697 |
| 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
Australia
Brazil
Canada
China
France
India
Japan
Netherlands
Poland
Republic of Korea
Slovakia
Taiwan
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Frankleena Parage |
All India Institute of Medical Sciences (AIIMS) - Nagpur |
Department of Cardiovascular & Thoracic Surgery, Plot 2, Sector 20, Mihan, Nagpur, Maharashtra, India, 441108
Nagpur
MAHARASHTRA |
9209197577
frankleenaparage@gmail.com |
| Dr Raja Lahiri |
All India Institute of Medical Sciences - Rishikesh |
Department of Cardiovascular & Thoracic Surgery, Virbhadra Road, Near Barrage, Rishikesh, Uttarakhand, India, 249203
Dehradun
UTTARANCHAL |
9935615903
raja.ctvs@aiimsrishikesh.edu.in |
| Dr Anil Ramesh Jawahirani |
Central lndia Cardiology Hospital and Research lnstitute |
Plot No.1, Pioneer Co-Op. Housing Society, Gawande Layout, Khamla Ring Road, Opp Sawarkar Garden, Khamla, Nagpur - 440015, Maharashtra, India
Nagpur
MAHARASHTRA |
9822220936
anilramesh123@rediffmail.com |
| Dr Rajesh S |
Government Medical College - Kozhikode |
Department of General Medicine, Ground Floor, Opposite OP Pharmacy, Kozhikode, Kerala, India, 673008
Kozhikode
KERALA |
9495666454
drrajeshstrials@gmail.com |
| Dr Md Azharuddin Malik |
Jawaharlal Nehru Medical College |
Department of Cardiology, AMU Campus, Aligarh, Uttar Pradesh, India, 202002
Aligarh
UTTAR PRADESH |
8126320218
malikazharuddin@gmail.com |
| Dr Hitendra Bhagwatkar |
Lata Mangeshkar Hospital - Digdoh |
Hrudayaa Cardiac and Vascular Care Center, Hingna Road, Ground Floor, N.K.P. Salve Institute of Medical Sciences & Research Center and Lata Mangeshkar Hospital, Nagpur, Maharashtra, India, 440019
Nagpur
MAHARASHTRA |
7104665000
hitendrabhagwatkar@gmail.com |
| Dr Santanu Dutta |
M. P. Birla Group - Belle Vue Clinic |
9, Dr. U. N. Brahmachari Street, Kolkata, West Bengal, India, 700017
Kolkata
WEST BENGAL |
9830808666
duttasantanu.cr@gmail.com |
| Dr Atul Damodar Abhyankar |
Nirmal Hospital Private Limited |
Ring Road, Surat-395002, Gujarat, India
Surat
GUJARAT |
9825145738
atulda@hotmail.com |
| Dr Piyush Joshi |
Priyanka Hospital and Cardiac Center |
77/01, Sector 7 Aravali Marg, Mansarovar, Jaipur, Rajasthan - 302020, India
Jaipur
RAJASTHAN |
9829025555
drpiyush.phcc@gmail.com |
| Dr Sawhney Jitendra Pal Singh |
Sir Ganga Ram Hospital |
Cardiology Department, Rajinder Nagar, 5th Floor, A- Block, New Delhi, Delhi, India, 110060
New Delhi
DELHI |
9810059773
jpssawhney@yahoo.com |
| Dr Vikrant Vijan |
Vijan Hospital & Research Centre |
Department of Cardiology, Dr Vijan Hospital Marg, College Road, Nashik, Maharashtra, India, 422005
Nashik
MAHARASHTRA |
9539681750
vikrantvijan@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee relating to Clinical Trial, AIIMS Rishikesh |
Approved |
| IEC Belle Vue Clinic |
Approved |
| IEC Rughwani Child Care Centre and Hospital |
Approved |
| Institutional Ethics Committee for Clinical Trial, AIIMS Nagpur |
Approved |
| Institutional Ethics Committee N.K.P. Salve Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee Priyanka Hospital and Cardiac Center |
Approved |
| Institutional Ethics Committee, Government Medical College, Kozhikode |
Approved |
| Institutional Ethics Committee, Jawaharlal Nehru Medical College and Hospital |
Approved |
| Nirmal Hospital Ethics Committee |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Approved |
| Vijan Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I739||Peripheral vascular disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Orforglipron |
Participants will receive orforglipron orally |
| Comparator Agent |
Placebo |
Participants will receive placebo orally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Have symptomatic PAD with intermittent claudication of Fontaine Stage II
2. Have an Ankle Brachial Index (ABI) of 0.9 or less |
|
| ExclusionCriteria |
| Details |
1. Have a body mass index (BMI) less than 23 kilogram per square meter (kg/m2)
2. Have Hemoglobin A1c (HbA1c) greater than 10%
3. Have walking ability limited by conditions other than PAD
4. Have a planned lower limb surgery or any other surgery affecting walking ability
5. Had peripheral revascularization procedure within 90 days prior to the day of screening or planning to undergo peripheral revascularization during the clinical trial
6.Had stroke, transient ischemic attack, myocardial infarction, coronary or carotid revascularization, or hospitalization for unstable angina pectoris within 60 days prior to screening
7. Have heart failure presently classified as being in New York Heart Association class III - IV |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percent Change from Baseline in Maximum Walking Distance |
Baseline, Week 52 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Percent Change from Baseline in Pain Free Walking Distance
2. Change from Baseline in Vascular Quality of Life (VascuQoL-6) Questionnaire Score
3. Change from Baseline in 6 Minute Walk Test Distance (meters)
4. Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
5. Change from Baseline in Systolic Blood Pressure (mmHg) |
Baseline, Week 52 |
|
|
Target Sample Size
|
Total Sample Size="1205"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
05/06/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="7"
Days="16" |
|
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 31-10-2025 and end date provided 16-06-2028?
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 evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks. |