CTRI/2025/04/085487 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On:
28/04/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Evaluation of Efficacy, Safety and Immunogenicity of Semaglutide injection in Weight Management
Scientific Title of Study
A Multicenter, Randomized, Comparative, Active-Controlled, Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety and Immunogenicity of Semaglutide injection in Weight Management
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/23/013, Version 3.0, Dated 16/JAN/2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
AVP and Head-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban)
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Supriya Sonowal
Designation
Medical Monitor-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban)
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
Supriya.Sonowal1@sunpharma.com
Details of Contact Person Public Query
Name
Chaitali Bornare
Designation
Senior Manager 2-Medical Affairs & Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon
east. Mumbai (Suburban)
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
Chaitali.Bornare1@sunpharma.com
Source of Monetary or Material Support
Sun Pharmaceutical Industries Limited (SPIL), Sun House, Plot No. 201 B/1, Western Express
Highway, Goregaon (E), Mumbai 400 063, Maharashtra, India.
Primary Sponsor
Name
Sun Pharmaceutical Industries Limited (SPIL)
Address
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon(E), Mumbai 400 063, Maharashtra, India.
Amrita institute of Medical Sciences and Research Centre
AIMS Ponekkara, P.O, Kochi-682041, Kerala, India. Ernakulam KERALA
9895545190
harishkumar@aims.amrita
Dr Ameya Joshi
Bhaktivedanta Hospital and Research Institute
Bhaktivedanta Hospital and Research Institute, Srishti complex, Bhaktivedanta Swami Marg, Mira Road ( East), Thane-401107, Maharashtra, India Thane MAHARASHTRA
9820235675
ameyaable@gmail.com
Dr Brij Mohan
Brij Medical Centre pvt ltd
Brij Medical Centre pvt ltd, 94- E, Panki, Kanpur - 208020, Uttar Pradesh Kanpur Nagar UTTAR PRADESH
9415043744
drbrijmohanbmc@gmail.com
Dr Unnikrishnan Ambika Gopalakrishnan
Chellaram Diabetes Institute
1st Floor, Lalani Quantum, Pune-Bangalore NH 4, Bavdhan (Budruk), Pune-411021, Maharashtra, India. Pune MAHARASHTRA
9689287337
uagcdi@cdi.org.in
Dr Arunkumar R
Chettinad Hospital & Research Institute
Chettinad Health city, Rajiv Gandhi, Salai (OMR), Kelambakkam, Chengalpattu -603103, Tamil Nadu Kancheepuram TAMIL NADU
Dr. M.K. Shah Medical College and Research Centre and Smt. S.M.S Multispeciality Hospital
Dr. M.K. Shah Medical College and Research Centre and Smt. S.M.S Multispeciality Hospital, Visat-Gandhinagar Highway, Near Tapvan Circle, Chandkheda, Ahmedabad, Gujarat 382424, India Ahmadabad GUJARAT
9909961887
bhavikap87@yahoo.com
Dr Sirisha Peddi
Gandhi Hospital
In patient Block, 2nd Floor, Department of General Medicine, Gandhi Hospital, Musheerabad, Secunderabad, Telangana, India-500003 Hyderabad TELANGANA
9701859566
sirishabhaskar.sirisha@gmail.com
Dr Ramesh
Government Medical College & Hospital
Government Medical College & Hospital,
Omandurar Govt. Estate, Chennai - 600002
Chennai TAMIL NADU
Health1 super speciality hospital, Near Venitian Villa, Shilaj Circle, S.P. Ring Rd, Thaltej, Ahmedabad, Gujarat 380059 Ahmadabad GUJARAT
8780449418
drakashendocrine@gmail.com
Dr Arvind Kumar Ojha
ILS Hospital
Dum Dum, 1 Mall Road, Khudiram Bose Sarani, Near Nager Bazar Flyover, Kolkata, West Bengal – 700080, India Kolkata WEST BENGAL
9831833197
ojha.arvind2003@gmail.com
Pranab Kumar Sahana
Institute of Post Graduate Education & Research and SSKM Hospital
244 AJC Bose Road, Kolkata 700020, West Bengal, India. Kolkata WEST BENGAL
9231523624
pranabsahana@gmail.com
Dr Amit Bhaskar
Janta Hospital and Maternity Center
Janta Hospital and Maternity Center, Near Water Head Tank,
Amara-Akhari Bypass, Chunar Road Varanasi, Uttar Pradesh- 221011, India Varanasi UTTAR PRADESH
9198677778
dramitbhaskarvns@gmail.com
Dr Sanjiv Maheshwari
Jawahar Lal Nehru Medical College
Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer 305001, Rajasthan. Ajmer RAJASTHAN
Department of General Medicine,
Rajendra Prasad Ward, Andhra Medical College, King George Hospital,
Visakhapatnam-530002, Andhra Pradesh, India.
Visakhapatnam ANDHRA PRADESH
9393104578
drvsatyaprasadresearch@gmail.com
Dr Nutan Kumar Agrawal
M.L.B Medical College
M.L.B Medical College, Kanpur Road, Jhansi 284128 (U.P) India Jhansi UTTAR PRADESH
9839789378
dr_nutan_agrawal@yahoo.com
Dr Rekha MC
Mandya Institute of Medical Science
Mandya Institute of Medical Science, Mysore – Bangalore Highway, Mandya - 571401 Mysore KARNATAKA
9845343736
drrekhamc@gmail.com
Dr Animesh Maiti
Medical College & Hospital
Department of Endocrinology, Medical College & Hospital, 88 Collage Street, Kolkata, West Bengal, 700073 Kolkata WEST BENGAL
9830936076
animeshmaiti73@gmail.com
Dr Ambrish C
Medstar Speciality Hospital
2nd Floor, #641/17/1/3, Kodigehalli Main Road, Sahakar nagar, Bangalore-560092, Karnataka, India Bangalore KARNATAKA
9845895911
drambrish.medstar@gmail.com
Dr Bahulikar Yash Arun
MMFHA Joshi Hospital
778, Shivajinagar Opp. Kamala Nehru park, Pune-411004 Pune MAHARASHTRA
020 - 41096666
dr.yashbahulikar0308@gmail.com
Dr Jitendra Shukla
Moti Lal Nehru Medical College
Moti Lal Nehru Medical College, George Town, Civil Line, Prayagraj, UP-211002
Allahabad UTTAR PRADESH
8527483333
drjitendramln@gmail.com
Dr Arjun Baidya
Nil Ratan Sircar Medical College & Hospital
Department of Endocrinology 138, A.J.C Bose Road Kolkata West Bengal - 700014 India. Kolkata WEST BENGAL
9433154618
Arjun.baidya@gmail.com
Dr Niranjan Pathak
OJAS Multispeciality Hospital
Sr no 203/1, D Y Patil College Road, Ravet, Pune-412101 Pune MAHARASHTRA
Department of Endocrinology
& Metabolism, Institute of Medical Sciences, Banaras Hindu University 2nd Floor, CSSB Building,
Varanasi, Uttar Pradesh -221005, India.
Varanasi UTTAR PRADESH
9919813255
riteshgsvm@gmail.com
Dr Arvind Palawat
SMS Hospital
G-1, Department of Medicine Dhanvantri, OPD Block SMS Hospital, Jaipur-302004 Jaipur RAJASTHAN
9828025364
drpalawat@gmail.com
Dr Pravin Supe
Supe Heart and Diabetes Hospital and Research Centre
Supe Heart and Diabetes Hospital and Research Centre.
Opp. Adhar Asharam, Near Rungta School, Gharpure Ghat, Ashok Stambh, Nasik 422002, Maharashtra, India.
Nashik MAHARASHTRA
9405366165
pravinsupe@ymail.com
Dr Shweta Bhandari
Vincare Hospital
Vincare Hospital, 100 Feet Road Opp, Petrol Pump Bathinda, Punjab – 151001, India. Bathinda PUNJAB
Research Oversight Committee, IPGME&R and SSKM Hospital
Approved
Sahyadri Hospitals Pvt Ltd Ethics Committee
Approved
Supe Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: E669||Obesity, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Semaglutide Injection of SPIL (0.25mg/0.5mg/1mg/1.7mg/2.4mg)
Subcutaneous injection once weekly, on the same day each week, at any time of day, with or without meals from Day 1 to week 23.
Comparator Agent
Wegovy (semaglutide) solution for injection in a single-dose pre-filled pen of Novo Nordisk A/S. (0.25mg/0.5mg/1mg/1.7mg/2.4mg)
OR
Wegovy Flex Touch (semaglutide) solution for injection in multi-dose pre-filled pen of Novo Nordisk A/S. (0.25mg/0.5mg/1mg/1.7mg/2.4mg)
Subcutaneous injection once weekly, on the same day each week, at any time of day, with or without meals from Day 1 to week 23.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Inclusion Criteria for all patients:
1. Male or female, aged 18 to 65 years (both inclusive) at the time of signing informed consent
2. Body mass index (BMI) greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia or type 2 diabetes mellitus (T2DM) at screening and randomization
3. Patients and their female partners of childbearing potential should agree to use contraceptive measures throughout the study and for at least 2 months after end of treatment. (Note: Acceptable methods of contraception: A. Male: Vasectomy, Condoms, Total abstinence; B. Females: hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] intrauterine devices, intrauterine hormone releasing system, bilateral tubal occlusion, or total sexual abstinence)
Inclusion Criteria applicable for Type 2 Diabetes Mellitus patients:
4. Diagnosed with T2D greater than or equal to 180 days prior to the day of screening
5. Subjects who are on a stable treatment with metformin, sulphonylurea (SU) or metformin + SU for at least 90 days before screening along with diet and exercise control.
ExclusionCriteria
Details
Exclusion Criteria for all patients:
1. History of type 1 diabetes mellitus
2. Treatment with a GLP-1 receptor agonist within 180 days before screening
3. Treatment with Semaglutide previously
4. A self-reported change in body weight greater than 5 kg within 90 days before screening irrespective of medical records
5. Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device.
However, the following are allowed:
• liposuction and/or abdominoplasty, if performed greater than 1 year before screening,
• lap banding, if the band has been removed greater than 1 year before screening,
• intragastric balloon, if the balloon has been removed greater than 1 year before screening or
• duodenal-jejunal bypass sleeve, if the sleeve has been removed greater than 1 year before screening
6. History of OR presence of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder etc.)
7. History of Suicidal behaviour or suicidal ideation within 30 days before screening
8. Calcitonin greater than or equal to 100 ng/L at screening
9. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
10. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR lesser than 30ml/min/1.73m2 [Note: eGFR will be calculated using MDRD formula]
11. Patients with aspartate transaminase [AST] greater than 2 x upper limit of normal [ULN] OR alanine transaminase [ALT] greater than 2 x ULN OR alkaline phosphatase [ALP] greater than 2 x ULN OR serum bilirubin greater than 1.5 x ULN) at Screening
12. History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
13. Known or suspected abuse of alcohol or recreational drugs
14. Known or suspected hypersensitivity to trial product(s) or related products
15. Participation in another clinical trial within 90 days before screening
16. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
17. Any disorder, which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol
Exclusion criteria for Non -Diabetic Patients:
18. HbA1c greater than or equal to 6.5% as measured at screening
Exclusion criteria for Diabetic Patients:
19. Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within the past 90 days prior day of screening
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Percentage change in body weight
From Baseline to week 24
Secondary Outcome
Outcome
TimePoints
Percentage change in body weight (For all patients)
From baseline to week 4, 8, 12, 16 and 20
Proportion of patients having body weight reduction greater than or equal to 5% (For all patients)
From baseline at week 4, 8, 12, 16, 20 and 24
Proportion of patients having body weight reduction greater than or equal to 10 % (For all patients)
From baseline at week 4, 8,12, 16, 20 and 24
Change in BMI (For all patients)
From baseline to week 4, 8, 12, 16, 20 and 24
Change in waist circumference (For all patients)
From baseline to week 4, 8, 12, 16, 20 and 24
Change in SF-36 total score (For all patients)
From baseline to week 4, 8, 12, 16, 20 and 24
Change in glycosylated hemoglobin (For Diabetic patients only)
From baseline to week 12 and 24
Change in FBG (For Diabetic patients only)
From baseline to week 4, 8, 12, 16, 20 and 24
Change in PPBG (For Diabetic patients only)
From baseline to week 4, 8, 12, 16, 20 and 24
Change in glycosylated hemoglobin (For Non-diabetic patients only)
From baseline to week 24
Change in FBG (For Non-diabetic patients only)
From baseline to week 24
Change in PPBG (For Non-diabetic patients only)
From baseline to week 24
Treatment Emergent Adverse Events (TEAEs)
Throughout the study period
Proportion of patients with anti-drug antibody (ADA) and Neutralising antibody (Nab) positive
Baseline and at week 24
Target Sample Size
Total Sample Size="267" Sample Size from India="267" Final Enrollment numbers achieved (Total)= "267" Final Enrollment numbers achieved (India)="267"
Phase of Trial
Phase 3
Date of First Enrollment (India)
05/05/2025
Date of Study Completion (India)
Date Missing
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="7" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
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 - NO
Brief Summary
This is a randomized, multi-centric, open-label, active-controlled, parallel, comparative, phase III study. The study will be conducted in approximately up to 20 centres from various parts of India, having qualified Investigators. The study will be initiated only after the receipt of regulatory and ethics committee (EC) approval.
After obtaining the informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessment (Appendix I). The total duration of the screening period will be of maximum 2 weeks (14 days). Patients will be issued a diary to record information about their meal, adverse events and medications during the screening period. Eligible patients will be randomized in 2:1 ratio to receive Sun’s Semaglutide (Test product) or Wegovy (Comparator product) respectively. Patients will receive total 24 doses of the study drug (either test or reference according to randomization) from week 0 till week 23. The study drug will be administered as weekly subcutaneous injection in abdomen, thigh or upper arm.
The doses of the study drug will be started at 0.25 mg and escalated to receive 2.4 mg at week 16 (Escalation phase). From week 16 to week 23 patients will receive the study drug at a dose of 2.4 mg (Maintenance phase). Patients will self-administer the drug at home. Patients will visit the site every 4 weeks. On the day of site visit patient can be administered the study drug at site and also counselled and trained on study drug administration at home. Patients will also be required to follow dietary restriction during the study as advised by a dietician. Patients will also be required to record details about study drug administration, concomitant medications and adverse events in the diary. Patients will be required to bring the completed diary at each visit. Patients will also be required to record details about study drug administration, concomitant medications and adverse events in the diary. Patients will be required to bring the completed diary at each visit.