| CTRI Number |
CTRI/2023/12/060509 [Registered on: 18/12/2023] 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 Participants with Obesity or Overweight |
|
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 with Weight-Related Comorbidities (ATTAIN-1) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| J2A-MC-GZGP (b) dated 11-May-2023 |
Protocol Number |
| NCT05869903 |
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 |
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
|
|
|
Countries of Recruitment
|
India
Brazil
China
Japan
Republic of Korea
Slovakia
Spain
Taiwan
United States of America |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Debasish Hota |
All India Institute of Medical Sciences (AIIMS) - Bhubaneswar |
115, Academic Block, Department of Pharmacology, Sijua Patrapada, Bhubaneswar, Odisha, India, 751019
Khordha
ORISSA |
9438884190
debhota@gmail.com |
| Dr Rajashree Sanjay Khot |
All India Institute of Medical Sciences (AIIMS) - Nagpur |
Plot No. 2, Sector 20, MIHAN, Department of General Medicine, Sumthana, Nagpur, Maharashtra, India, 441108
Nagpur
MAHARASHTRA |
9823134598
rajashree.s.khot@gmail.com |
| Dr Vaishali Chetan Deshmukh |
Deenanath Mangeshkar Hospital and Research Centre |
Department of Endocrinology, SS Building, Ground Floor, Erandwane, Pandurang Colony, Pune, Pune Maharashtra, India, 411004
Pune
MAHARASHTRA |
9850811450
drvaishaliresearch@gmail.com |
| Dr Kongara Srikanth |
Endolife Speciality Hospitals Pvt. Ltd. |
No. 12-12-94, Old Club Road, 1st Floor, Kothapet, Guntur, Andhra Pradesh, India,522001
Guntur
ANDHRA PRADESH |
9849945577
srikanthendo@gmail.com |
| Dr Rajesh Vithal Gosavi |
Government Medical College and Hospital – Nagpur (Internal Medicine) |
Department of Internal Medicine, Medical College Square Road, Nagpur, Maharashtra, India, 440003
Nagpur
MAHARASHTRA |
91-9890225111
gosavirv@hotmail.com |
| Dr Gupta Hemant Ramsharan |
Grant Govt. Medical College and Sir J.J. Group of Hospitals |
JJ Marg, Nagpada-Mumbai Central, Byculla, Mumbai, Maharashtra, India, 400008
Mumbai
MAHARASHTRA |
9870456788
drhemantgupta@hotmail.com |
| Dr Sumaiya Anjum |
K.R. Hospital, Attached to Mysore Medical College and Research Institute |
First Floor, Department of Medicine, Irwin Road, Mysore, Karnataka, India, 570001
Mysore
KARNATAKA |
7760218464
dr.sumaiyaanjum@gmail.com |
| Dr Dange Amol Laxmanrao |
Lifepoint Multispecialty Hospital |
145/1 Mumbai Bangalore Highway, 3rd floor, Clinical Research Department, Near Hotel Sayaji, Wakad, Pune, Maharashtra, India, 411057
Pune
MAHARASHTRA |
02066434366
amoldange298@gmail.com |
| Dr Shashank Shah |
Sahyadri Super Speciality Hospital (Sahyadri Clinical Research and Development Center) |
Plot No. 30C, Erandwane, Karve Road, Deccan, Gymkhana, Pune, Maharashtra, India, 411004
Pune
MAHARASHTRA |
9822026734
drshashanks@gmail.com |
| Dr Chandrashekar Mathod |
Victoria Hospital, Bangalore Medical College and Research Institute |
K.R. Road, Room 322, 3rd Floor, OPD Block, Victoria Hospital, BMCRI, Fort, Bangalore, Karnataka, India, 560002
Bangalore
KARNATAKA |
9113030135
drchandrashekarbmcri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee of Bangalore Medical College and Research Institute |
Approved |
| Institutional Ethics Committee of Deenanath Mangeshkar Hospital |
Submittted/Under Review |
| Institutional Ethics Committee of Endolife Speciality Hospitals Pvt. Ltd. |
Approved |
| Institutional Ethics Committee, AIIMS - Nagpur |
Submittted/Under Review |
| Institutional Ethics Committee, AIIMS Bhubaneswar |
Submittted/Under Review |
| Institutional Ethics Committee, Department of Pharmacology, Government Medical College and Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, New Healthcare Nursing home |
Submittted/Under Review |
| Institutional Ethics Committee- Mysore Medical College and Research Institute and Associated Hospitals |
Approved |
| Lifepoint Research Ethics Committee |
Approved |
| Sahyadri Hospitals Pvt Ltd Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z68||Body mass index [BMI], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LY3502970 |
Daily oral dose of 1 mg LY3502970 and increase dose every 4 weeks until the randomized maintenance dose (6 mg, 12 mg or 36 mg) is reached. The study will last up to 77 weeks for participants without prediabetes at baseline and 181 weeks for participants with prediabetes at baseline. |
| Comparator Agent |
Placebo |
Capsule of LY3502970 placebo to match once daily orally. The study will last up to 77 weeks for participants without prediabetes at baseline and 181 weeks for participants with prediabetes at baseline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Have a BMI ≥30.0 kilogram/square meter (kg/m²),
or ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening: Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
2. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
|
|
| ExclusionCriteria |
| Details |
1. Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
2. Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
3. Have family (first-degree relative) or personal history of MTC or MEN2 syndrome.
4. 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 to Week 72 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean Change from Baseline in Waist Circumference
2. Mean Change from Baseline in Systolic Blood Pressure (SBP)
3. Mean Percent Change from Baseline in Fasting non-HDL Cholesterol
4. Mean Percent Change from Baseline in Fasting Triglycerides
5. Mean Change from Baseline in HbA1c (%)
6. Mean Change from Baseline in Fasting Glucose
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 SF-36v2 acute form domain scores |
Baseline, Week 72 |
|
|
Target Sample Size
|
Total Sample Size="3000"
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)
|
15/01/2024 |
| 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="3"
Months="8"
Days="9" |
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
- 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
|
From 1998 to 2018, the prevalence of obesity is rapidly spurting due to sedentary lifestyle and consumption of high calories food. In India, more than 135 million individuals were affected by obesity. Treatment with glucagon-like peptide-1 receptor agonist and dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonists has shown body weight reduction of a greater magnitude compared to conventional pharmacologic anti-obesity therapies. Despite these advancements, bariatric surgery, such as RY-gastric bypass or sleeve gastrectomy remains the only approved treatment that achieves average body weight reduction of 30 to 32%. There remains an unmet medical need for pharmacologic treatments that are safe, efficacious, and well tolerated in patients with overweight and obesity. Hence, this study which aims to investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities is hopeful to clarify its safety and efficacy in order to be considered as a potential treatment candidate. |