FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/11/060209 [Registered on: 23/11/2023] Trial Registered Prospectively
Last Modified On: 22/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study of LY3502970 in Obese or Overweight and Diabetes Patients 
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 Obesity or Overweight and Type 2 Diabetes (ATTAIN-2) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT05872620  ClinicalTrials.gov 
Protocol No.: J2A-MC-GZGQ (b) dated 12-May-2023  Protocol Number 
 
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  09810308697  
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 and 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  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Brazil
China
Czech Republic
Germany
Greece
India
Republic of Korea
United States of America  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajashree Sanjay Khot  All India Institute of Medical Sciences (AIIMS) - Nagpur  Department of General Medicine, Plot 2 Sector 20, MIHAN, Sumthana, Nagpur, Maharashtra, India, 441108
Nagpur
MAHARASHTRA 		 9823134598

rajashree.s.khot@gmail.com 
Dr Arthur Joseph Asirvatham  Arthur Asirvatham Hospital  42-A, Kuruvikkaran Salai, Near Anna Busstand, Madurai, Tamil Nadu, India, 625020
Madurai
TAMIL NADU 		 919443751977

ajasirvathamresearch@yahoo.in 
Dr Jyoti Mannari  Bhaikaka University, Shree Krishna Hospital and Medical Research Center  Pramukhswami Medical College, Department of Medicine, Sree Krishna Hospital, Gokal Nagar, Karamsad, Anand, Gujarat, India, 388325
Anand
GUJARAT 		 2692222130

jyotigm1961@gmail.com 
Dr Manoj Chawla  BSES Municipal General Hospital  South V. Road, 7th floor, Opposite Railway Station, S V Road, Andheri West, Mumbai, Maharashtra, India, 400058
Mumbai
MAHARASHTRA 		 09820002333

drmanojchawla@yahoo.com 
Dr Meenakshi Bhattachrya  Department of Medicine, Government Medical College, Aurangabad  Panchakki Road, 2nd floor, Department of Medicine, Aurangabad, Maharashtra, India, 431001
Aurangabad
MAHARASHTRA 		 9922931527

mabhattacharya@gmail.com 
Dr Paturi Vishnupriya Rao  Diabetes Research Center  6.3.349.17B and 31, Dwarakapuri, Panjagutta, Hyderabad - 500082, India.
Hyderabad
TELANGANA 		 919885051110

diabetes.hyd@gmail.com 
Dr Ajay Aggarwal  Fortis Hospital  Clinical Research Department, Shalimar Bagh, A-Block, New Delhi, Delhi, India, 110088
New Delhi
DELHI 		 9953055198

endocrinologist39@yahoo.co.in 
Dr Ram S Kaulgud  Karnataka Institute of Medical Sciences  Department of Internal Medicine, PB Road, Vidyanagar, Hubli, Karnataka, India, 580022
Dharwad
KARNATAKA 		 918073626873

drkaulgud.kims@gmail.com 
Dr Ambrish C  Medstar Speciality Hospital  #641/17/1/3, Kodigehalli Main Road, Sahakarnagar, Bangalore, Karnataka, India, 560092
Bangalore
KARNATAKA 		 09884457106

drambrishc.medstar@gmail.com 
Dr Uday Phadke  Sahyadri Super Speciality Hospital  30-C, Erandwane, Karve Road, Pune, Maharashtra, India, 411004
Pune
MAHARASHTRA 		 9822025180

uday@drudayphadke.com 
Dr Nikhil Bhagwat  Topiwala National Medical College & B. Y. L. Nair Charitable Hospital  Department of Endocrinology, 4th Floor, Room No. 419, College Building, Dr. A.L. Nair Road, Mumbai central, Mumbai, Maharashtra, India, 400008
Mumbai
MAHARASHTRA 		 9820238399

bhagwatnik@yahoo.co.in 
Dr Sunil M Jain  TOTALL Diabetes Hormone Institute  PU 4 Scheme, 54, Behind Prestige Management Institute, Near Bombay Hospital, Indore, Madhya Pradesh, India, 452010
Indore
MADHYA PRADESH 		 919826023182

sunilmjain@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
BSES Municipal General Hospital Ethics Committee  Submittted/Under Review 
Ethics Committee of Diabetes Thyroid Hormone Research Institute  Approved 
Institutional Ethics Committee, All India Institute of Medical Sciences, Nagpur  Submittted/Under Review 
Institutional Ethics Committee, Arthur Asirvatham Hospital  Approved 
Institutional Ethics Committee, Bhailaka University  Submittted/Under Review 
Institutional Ethics Committee, Department of Pharmacology, Government Medical College  Submittted/Under Review 
Institutional Ethics Committee, Diabetes Research Center  Approved 
Institutional Ethics Committee, Fortis Hospital  Submittted/Under Review 
Institutional Ethics Committee, Karnataka Institute of Medical Sciences  Approved 
Institutional Ethics Committee, Topiwala National Medical College & B. Y. L. Nair Charitable Hospital  Submittted/Under Review 
Medstar Speciality Hospital Ethics Committee  Approved 
Sahyadri Hospitals Pvt Ltd Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E66||Overweight and obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LY3502970  1 mg orally once-daily dose of LY3502970 initially. Dose to be increased every 4 weeks until randomized maintenance dose (6 mg, 12 mg or 36 mg). The study last up to 77 weeks. 
Comparator Agent  Placebo  matching placebo dose will be given. The study last up to 77 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Have a BMI ≥27.0 kg/m²
2. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
3. Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of: either diet/exercise alone or up to 3 oral antihyperglycemic medications (excluding DPP-4i or GLP-1 RA).
 
 
ExclusionCriteria 
Details  1. Have Type 1 Diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
2. Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
3. Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laser photocoagulation or intravitreal injections of anti- vascular endothelial growth factor inhibitors).
4. Have family (first-degree relative) or personal history of MTC or MEN2 syndrome.
5. Have had a history of chronic or acute pancreatitis.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Mean Percent Change from Baseline in Body Weight   Baseline, Week 72 
 
Secondary Outcome  
Outcome  TimePoints 
1. Mean Change from Baseline in Waist Circumference
2. Mean Change from Baseline in Hemoglobin A1c (HbA1c) %
3. Mean Change from Baseline in Fasting Glucose
4. Mean Change from Baseline in Systolic Blood Pressure (SBP)
5. Mean Change from Baseline in Fasting Triglycerides
6. Mean Percent Change from Baseline in Fasting non-High-Density Lipoprotein (HDL) Cholesterol
7. Mean Percent Change from Baseline in Fasting Insulin
8. Mean Change from Baseline in Diastolic Blood Pressure (DBP)
9. Mean Change from Baseline in Short Form 36 Version 2 Health Survey Acute Form (SF-36v2) Domain Scores 		 Baseline, Week 72 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="120" 
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)   15/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/06/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="12" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 01-12-2023 and end date provided 31-05-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits. 
Close