| CTRI Number |
CTRI/2024/01/061307 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| 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 Orforglipron (LY3502970) in Adults With Type 2 Diabetes |
|
Scientific Title of Study
|
A Phase 3, Randomized, Double-Blind Study to Investigate the
Efficacy and Safety of Once Daily Oral LY3502970 Compared with Placebo in Adult
Participants with Type 2 Diabetes and Inadequate Glycemic Control with Diet and
Exercise Alone (ACHIEVE-1) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| J2A-MC-GZGT Version No. a dated 22-May-2023 |
Protocol Number |
| NCT05971940 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Manish Mistry |
| 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 |
9820234897 |
| Fax |
|
| Email |
manish.mistry@lilly.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Manish Mistry |
| 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 |
9820234897 |
| Fax |
|
| Email |
manish.mistry@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
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, Sector-32, Gurgaon, Haryana-122001 |
|
|
Primary Sponsor
|
| Name |
Eli Lilly Company India Pvt Ltd |
| Address |
Eli Lilly and Company (India) PVT LTD, Plot No.92, Sector-32, Gurgaon, Haryana - 122001 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
China
India
Japan
Mexico
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Udit Narang |
All India Institute of Medical Sciences (AIIMS) - Nagpur |
Plot No. 2, Sector 20, MIHAN, 2nd Floor, Room No. 239, Department of General Medicine, Sumthana, Nagpur, Maharashtra, India, 441108
Nagpur
MAHARASHTRA |
9970505548
uditnarang@gmail.com |
| Dr Parmar Kartikeya Ganpatlal |
B.J. Medical College & Civil Hospital |
3rd Floor Emergency (Trauma Centre), Civil Hospital Road, Asarwa, Ahmedabad, Gujarat, India, 380016
Ahmadabad
GUJARAT |
9924643799
drkartik@gmail.com |
| Dr Manoj Chawla |
BSES Municipal General Hospital |
Clinical Research Unit, Opp. Railway Station, South V. Road, Andheri (W), Mumbai, Maharashtra, India, 400058
Mumbai
MAHARASHTRA |
9820002333
drmanojchawla@yahoo.com |
| Dr Paturi Vishnupriya Rao |
Diabetes Research Center |
6.3.349.17B and 31, Dwarakapuri, Panjagutta, Hyderabad - 500082, India.
Hyderabad
TELANGANA |
9885051110
diabetes.hyd@gmail.com |
| Dr Meenakshi Shah |
GMERS Medical College and General Hospital Gotri |
Department of Internal Medicine, Gotri Road, Old TB Campus, Vadodara, Gujarat, India, 390021
Vadodara
GUJARAT |
9558275888
drmeenakshi30@yahoo.com |
| Dr Sanjay Agarwal |
Grant Medical Foundation - Ruby Hall Clinic |
Department of Internal Medicine, 40 Sassoon Road, Ground Floor Main Building, Sassoon Road, Pune, Maharashtra, India, 411001
Pune
MAHARASHTRA |
9822091220
sanjayagarwal.trials@gmail.com |
| Dr Sujoy Ghosh |
Institute of Post Graduate Medical Education and Research |
Department of Endocrinology, 244, Acharya Jagadish Chandra Bose Rd, Bhowanipore, Kolkata, West Bengal, India, 700020
Kolkata
WEST BENGAL |
9674625823
drsujoyghosh2000@gmail.com |
| Dr Chitra Selvan |
M S Ramaiah Medical College and Hospital |
M S Ramaiah Nagar, MSRIT Post, Bangalore, Karnataka, India, 560054
Bangalore
KARNATAKA |
08040502983
chitraselvan@gmail.com |
| Dr Viswanathan Mohan |
Madras Diabetes Research Foundation |
4 Conran Smith Road, Gopalupuram, Chennai, Tamil Nadu, India, 600086
Chennai
TAMIL NADU |
9840134505
drmohans@diabetes.ind.in |
| Dr Ambrish C |
Medstar Speciality Hospital |
#641/17/1/3, Kodegehalli Main Road, Sahakarnagar, Bangalore, Karnataka, India, 560092
Bangalore
KARNATAKA |
9884457106
drambrishc.medstar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| BSES MGH Ethics Committee |
Submittted/Under Review |
| Ethics Committee, M S Ramaiah Medical College and Hospital |
Submittted/Under Review |
| Institutional Ethics Committee for Clinical Trial, AIIMS - Nagpur |
Submittted/Under Review |
| Institutional Ethics Committee of Madras Diabetes Research Foundation |
Approved |
| Institutional Ethics Committee Poona Medical Research Foundation |
Approved |
| Institutional Ethics Committee, B.J. Medical College & Civil Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Diabetes Research Center |
Approved |
| Institutional Human Ethics Committee, GMERS Medical College and General Hospital Gotri |
Submittted/Under Review |
| IPGME&R Research Oversight Committee |
Submittted/Under Review |
| Medstar Speciality Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Orforglipron / LY3502970 |
Initial dose of 1mg of LY3502970 administered orally daily. The dose will increase every 4 weeks until 3mg, 12 mg and 36 mg. The study duration will be approximately 46 or 54 weeks, depending on whether the prescreening visit will be included. |
| Comparator Agent |
Placebo |
Placebo administered orally daily. The study duration will be approximately 46 or 54 weeks, depending on whether the prescreening visit will be included. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
- Have Type 2 Diabetes
- Have HbA1c ≥7.0% (53 mmol/mol) to ≤9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening.
- Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization.
- Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
- Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening. |
|
| ExclusionCriteria |
| Details |
- Have Type 1 Diabetes
- Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
- Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
- Have New York Heart Association functional classification IV congestive heart failure.
- Have acute or chronic hepatitis |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from Baseline in Hemoglobin A1c (HbA1c) |
Baseline, Week 40 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol)
Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol)
Percentage of Participants Who Achieved Weight Loss of ≥5%
|
Week 40 |
Change from Baseline in Fasting Serum Glucose
Percentage Change from Baseline in Body Weight
Change from Baseline in Body Weight
Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG)
Change from Baseline in Systolic Blood Pressure (SBP)
Change from Baseline in Non-HDL Cholesterol
Change from Baseline in Triglycerides
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores |
Baseline, Week 40 |
|
|
Target Sample Size
|
Total Sample Size="520"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "559"
Final Enrollment numbers achieved (India)="83" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/01/2024 |
| Date of Study Completion (India) |
12/03/2025 |
| Date of First Enrollment (Global) |
09/08/2023 |
| Date of Study Completion (Global) |
03/04/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="25" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 01-01-2024 and end date provided 30-06-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks. |