FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/096855 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
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 Orfoglipron in Patients with Hypertension and Obesity or Overweight 
Scientific Title of Study   A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants with Hypertension and Obesity or Overweight: Randomized, Double-Blind, Placebo-Controlled Trials (ATTAIN-HYPERTENSION) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
J2A-MC-GZPL Version No. Initial dated 24-JAN-2025  Protocol Number 
NCT06948422  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manish Mistry 
Designation  Medical Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd. 
Address  Office of Senior Director - Medical (India), Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA-122001 India

Gurgaon
HARYANA
122001
India 
Phone  09820234897  
Fax    
Email  manish.mistry@lilly.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manish Mistry 
Designation  Medical Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd. 
Address  Office of Senior Director - Medical (India), Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA-122001 India

Gurgaon
HARYANA
122001
India 
Phone  09820234897  
Fax    
Email  manish.mistry@lilly.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajeev Sharan Shrivastava 
Designation  Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd. 
Address  Office of Director - Regulatory Affairs and Pharmacovigilance, Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA-122001 India

Gurgaon
HARYANA
122001
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
China
Czech Republic
Germany
Greece
India
Japan
Poland
Spain
United States of America  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Debasis Acharya  All India Institute of Medical Sciences, Bhubaneswar  Room No. 259, 2nd Floor, Hospital Building, Department of Cardiology, Sijua, Patrapada, Bhubaneswar, Odisha, India, 751019
Khordha
ORISSA 		 91-7675992616

drdebasiscardio.trial@gmail.com 
Dr Anuj Bhasin  Ashirwad Hospital and Research Centre  Maratha Section, Near Jijamata Udyan, Ulhasnagar, Thane, Maharashtra, India, 421004
Thane
MAHARASHTRA 		 91-9823932501

dranuj.research@gmail.com 
Dr Vimal Mehta  G.B. Pant Institute of Postgraduate Medical Education & Research  Room No-133, First Floor, Academic Block, Department of Cardiology, Jawahar Lal Nehru Marg, New Delhi, Delhi, India, 110002
New Delhi
DELHI 		 91-9718599105

drvimalmehta@yahoo.co.in 
Dr Kumar K  Life Care Hospital and Research Centre  2748/2152 M.L.N Enclave, 16th East Cross Road, 8th Main, D Block, Next to Union Bank of India, Sahakarnagar, Bangalore, Karnataka, India, 560092
Bangalore
KARNATAKA 		 91-8861499206

drkumarklchrc25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ashirwad Ethics Committee  Approved 
Institutional Ethics Committee MAMC  Submittted/Under Review 
Institutional Ethics Committee, AIIMS, Bhubaneswar  Submittted/Under Review 
Life Care Hospital Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Orforglipron  Orforglipron orally administered once daily. The treatment duration will be up to 60 weeks. 
Comparator Agent  Placebo  Placebo orally administered once daily. The treatment duration will be up to 60 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Has systolic blood pressure (SBP) greater than or equal to 140 mmHg and/or diastolic blood pressure (DBP) greater than or equal to 90 mmHg (if DBP criteria alone is met, SBP must be greater than or equal to 130 mmHg) at screening (Visit 1).
2. Has SBP greater than or equal to 140 mmHg and/or DBP greater than or equal to 90 mmHg (if DBP criteria alone is met, SBP must be greater than or equal to 130 mmHg) at week 0 (Visit 3).
3. Untreated for hypertension, or on stable antihypertensive medications greater than or equal to 30 days prior to Visit 1.
4. Have a body mass index (BMI) greater than or equal to 25 kg/m². 
 
ExclusionCriteria 
Details  1. Has SBP greater than or equal to 170 mmHg and/or DBP greater than or equal to 110 mmHg at Visit 1 or at Visit 3.
2. Has known secondary causes of hypertension
3. Have heart failure with reduced ejection fraction (HFrEF) diagnosis
4. Have had any of the following conditions within 90 days prior to screening:
- hospitalization for hypertension or for congestive heart failure
- acute coronary syndrome or acute myocardial infarction, or
- cerebrovascular accident (stroke).
5. Have type 1 diabetes (T1D)
6. Have acute or chronic hepatitis, including a history of autoimmune hepatitis 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from Baseline in office Systolic Blood Pressure (SBP)  Baseline to Week 36 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change from Baseline in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP
2. Percent Change from Baseline in Body Weight
3. Percent Change from Baseline in Lipids Triglycerides
4. Percent Change from Baseline in Lipids non-HDL Cholesterol
5. Percent Change from Baseline in hsCRP Concentration (mg/L)
6. Percent Change from Baseline in office SBP in Randomized Withdrawal Population
7. Pharmacokinetics (PK): Steady-State Area under the Concentration Curve (AUC) of Orforglipron 		 1. Baseline to Week 36
2. Baseline to Week 36
3. Baseline to Week 36
4. Baseline to Week 36
5. Baseline to Week 48
6. Baseline to Week 60
7. Baseline to Week 36 
 
Target Sample Size   Total Sample Size="974"
Sample Size from India="90" 
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)   05/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="4"
Days="26" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 30-04-2025 and end date provided 25-09-2027?
    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  
Glucagon-like peptide 1 receptor agonism (GLP-1 RA) is an established therapeutic mechanism for weight management in individuals with obesity or overweight, as well as glycemic control in participants with type 2 diabetes (T2D). In addition to those beneficial effects, clinical trials have also demonstrated that the use of GLP-1 RA in patients with overweight and obesity or with diabetes have shown a significant reduction of blood pressure (BP). 
Unlike injectable or orally available peptide GLP-1 RAs approved by regulatory authorities to date, orforglipron is an oral, nonpeptide, small-molecule GLP-1 RA. Orforglipron is being developed as a daily oral adjunct therapy for several indications, including the treatment of T2D, and for weight management in individuals with obesity or overweight. Additionally, it has the potential to provide benefit to participants with hypertension who have obesity or overweight by achieving and maintaining BP control through adherence to effective treatments, which provides a strong rationale for assessing orforglipron to reduce BP and control hypertension in patients with overweight or obesity.
Study J2A-MC-GZPL (GZPL) is a master protocol that will support 2 pivotal, independent studies, J2A-MC-GZL1 (GZL1) and J2A-MC-GZL2 (GZL2). Each study is a multicenter, randomized, parallel-arm, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of orforglipron MTD versus placebo in participants with hypertension and obesity or overweight. 
 
Close