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CTRI Number  CTRI/2025/06/089367 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to Investigate the Efficacy and Safety of Semaglutide of Intas Compared to Wegovy FlexTouch in Overweight and Obese Adult Participants in Adjunct to Diet and Exercise 
Scientific Title of Study   A Prospective, Phase 3, Randomized, Interventional, Open-label, Parallel-Group, Multicentre, Active Controlled Study to Establish Noninferiority of Intas Semaglutide Subcutaneous Injection (Test) Against Innovator Semaglutide (Wegovy FlexTouch, Novo Nordisk) Subcutaneous Injection (Reference) in Overweight and Obese Adult Participants in Adjunct to Diet and Exercise 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No: 0131-24, Version: 1.0, Dated: 10-Feb-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Naman Shah 
Designation  Senior General Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club,S. G. Highway, Gota, Ahmadabad, Gujarat, India

Ahmadabad
GUJARAT
382481
India 
Phone  07940202389  
Fax  07940202021  
Email  namanshah@lambda-cro.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jogesh Mahajan 
Designation  Senior Vice President 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club,S. G. Highway, Gota, Ahmadabad, Gujarat, India

Ahmadabad
GUJARAT
382481
India 
Phone  07940202288  
Fax  07940202021  
Email  jogeshmahajan@lambda-cro.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jogesh Mahajan 
Designation  Senior Vice President 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club,S. G. Highway, Gota, Ahmadabad, Gujarat, India


GUJARAT
382481
India 
Phone  07940202288  
Fax  07940202021  
Email  jogeshmahajan@lambda-cro.com  
 
Source of Monetary or Material Support  
Intas Pharmaceuticals Limited, Corporate House, Near Sola Bridge, S.G. Highway, Thaltej, Ahmedabad, Gujarat, India. Pin code- 380054 
 
Primary Sponsor  
Name  Intas Pharmaceuticals Limited 
Address  Corporate House, Near Sola Bridge, S.G. Highway, Thaltej, Ahmedabad, Gujarat, India. Pin code- 380054 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 36  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivani  AIIMS, BATHINDA  Department of Clinical research, Room No. NA, Mandi, Dabwali road, bathinda, Punjab151001
Bathinda
PUNJAB 
9464739943

shivani66sidana@gmail.com 
Dr Henil Shah  Anand surgical Hospital pvt. ltd  Department of Clinical research, Room No. NA, Memco cross road, Naroda road, Ahmedabad-382345, Gujarat, India
Ahmadabad
GUJARAT 
7096038345

drhenilshah.research@gmail.com 
Dr Paramesh Shamanna  Bangalore Clinisearch   Department of Clinical research, Room No. NA, No.416, 4th Block, Kalyan Nagar, Bangalore - 560043 Bangalore, KARNATAKA
Bangalore
KARNATAKA 
9845010610

drparamesh2@gmail.com  
Dr Neeta Deshpande  Belgaum Diabetes centre   Department of Clinical research, Room No. NA, 2nd Floor, Maruti Galli,2nd Floor, Maruti Galli,-590001 Belgaum, KARNATAKA 
Belgaum
KARNATAKA 
9880271313

neetarohit@gmail.com  
Dr Manoj Chawla  BSES Muncipal General Hospital  Department of Clinical research, Room No. NA, BSES MG Hospital, 7th Floor Research Cabin, waiting area, Opposite railway station, SV Road, Andheri (W), Mumbai 58
Mumbai
MAHARASHTRA 
9820002333

linadiabetesresearch@gmail.com 
Dr Bipin sethi  CARE HOSPITALS  Department of Clinical research, Room No. NA, ROAD NO. 1 PREM NAGAR BANJARA HILLS HYDERABAD TELANGANA 500034
Hyderabad
TELANGANA 
9440739238

sethibipin54@gmail.com 
DR A G Unnikrishnan  Chellaram Diabetes lnstitute  Department of Clinical research, Room No. NA, 1st floor, Lalani Quantum, Pune-Bangalore NH 4. Bavdhan (Budruk) Pune, Maharashtra, India-411021
Pune
MAHARASHTRA 
8605011934

uagcdi@cdi.org.in  
Dr Sharat Kolke  CRITICARE ASIA MULTISPECIALITY HOSPITAL  Department of Clinical research, Room No. NA, KOHINOOR CITY, CRITICARE ASIA MULTI SPECIALITY HOSPITAL, KURLA WEST, MUMBAI, MAHARASHTRA 400070
Mumbai
MAHARASHTRA 
9820059062

sharatkolke@hotmail.com 
Dr Vaishali Deshmukh  Deenanath Mangeshkar Hospital and Research center   Department of Clinical research, Room No. NA, Deenanath Mangeshkar Hospital and Research center Pune, Super speciality Building, ground floor, Endocrinology Department, Erandwane Pune- 411004.
Pune
MAHARASHTRA 
9850811450

docvaishali@yahoo.co.in 
Dr Dhrumil Patel  Dhrumils Hospital  Department of Clinical research, Room No. NA, Hari darshan cross roads, avani icon-301, kathwada road, vasant vihar-2,naroda, abad382330
Ahmadabad
GUJARAT 
9724410751

dhrumil.synergy@gmail.com 
Dr Banshi Saboo  Dia care Research  Department of Clinical research, Room No. NA, 1-2, Gandhi Park, Near Nehru Nagar Cross Road, Ambawadi, Ahmedabad-380015, Gujarat, India
Ahmadabad
GUJARAT 
9824047676

banshisaboo98@gmail.com 
Dr Nikita Doshi  Doshis Diabtes and Endocrine center   Department of Clinical research, Room No. NA, Doshis Diabtes and Endocrine center Behind Tourist hotel, New Shahupuri, Kolhapur, Maharashtara India- 416001
Kolhapur
MAHARASHTRA 
9673990305

nikitadoshict@gmail.com 
Dr K D Modi  Dr MODIS CLINIC ( ADARSH NAGAR )   5-9-22/51,Beside Birla Temple Hill fort, Hyderabad- 500063
Hyderabad
TELANGANA 
9848115322

drmodisclinic@gmail.com 
Dr Vijay Sekhar Reddy  GANDHI MEDICAL COLLEGE AND HOSPITAL   Department of Clinical research, Room No. NA, BHIOGUDA ROAD M.I.G.H COLONY MUSHEERABAD WALKER TOWN PADMARAO NAGAR SECUNDERABAD TELANGANA 500025
Hyderabad
TELANGANA 
9849172161

drdvsreddyendo@yahoo.com 
DR Rizwan Ahmed Ansari  Hopewell Hospital  Department of Clinical research, Room No. NA, G-101, Sueml8, Ajit mill Cross Road, Ahmedabad, Gujarat, 380023
Ahmadabad
GUJARAT 
9033884736

drrizwanansari@yahoo.com 
Dr Mahesh Rath  Kalinga Hospital Ltd  Department of Clinical research, Room No. NA, Kalinga Hospital Limited, Chandrasekharpur, Bhubneshwar 751023
Khordha
ORISSA 
9938099079

dr.maheshrath@gmail.com 
Dr Nirav Shah  Kiran Multi Super Speciality Hospital and Research centre  Department of Clinical research, Room No. NA, Kiran Multi Super Speciality Hospital and Research centre, Near Sumul Dairy, Surat 395004
Surat
GUJARAT 
8320117490

drniravrshah@outlook.com 
Dr Ketan Mehta  Kkasturi Medicare PVT LTD  Department of Clinical research, Room No. NA, Harshniketan, Gaondevi Road, Near Navrang Hotel, Bhayendar West, Thane, Maharashtra- 401101
Thane
MAHARASHTRA 
8356003006

drketanmehta04@gmail.com 
Dr Manojitketan Mukhopadhyay  Life Line Diagnostics Centre Cum Nursing Home  Department of Clinical research, Room No. NA, 4A, Wood street, Kolkata-700016, West Bengal, India
Kolkata
WEST BENGAL 
9830203242

mkmukhopadhyay@yahoo.co.in 
Dr Prabhat Kumar Sharma  Maharaja Agrasen Superspeciality Hospital  Department of Clinical research, Room No. NA, Sector-7, Central Spine, Vidyadhar Nagar, Jaipur-302039, Rajasthan, India
Jaipur
RAJASTHAN 
9983995050

pksharma.clinical@gmail.com 
Dr Dinesh Agarwal  Marwari Hospitals  Department of Clinical research, Room No. NA, SJ Road, Athgaon, Guwahati-781008, Assam, India
Golaghat
ASSAM 
9864061456

drdinesh944@gmail.com 
Dr Pankaj Aneja  Naveda Healthcare Center  Department of Clinical research, Room No. NA, Sector 8 pocket A1 house no: 81rohini Delhi.85 – 110085
New Delhi
DELHI 
9811117266

drpankajaneja@gmail.com 
Dr Vaibhav Kothari  Navmeet Memorial Hospital "Sushrusha"  Department of Clinical research, Room No. NA, Opp. Sardar Patel Seva Samaj Hall, In lane, Opp. Navrangpura Telephone Exchange, Off. C. G. Road, Navrangpura, Ahmedabad-380006.
Ahmadabad
GUJARAT 
9979700995

drvaibhavkotharicr@gmail.com 
Dr Mayura Choudhari  Oriion Criticare Super Speciality Hospital  Department of Clinical research, Room No. NA, 5-5-70, Opp. Kalash Mangal Karyalaya, Osmanpura, Chhatrapati Shambhaji Nagar, 431005, Maharastra, India
Aurangabad
MAHARASHTRA 
9422713734

kalediabetesclinic@gmail.com 
DrRama Walia  PGIMER  Department of Clinical research, Room No. NA, Maghyamarg, sector-12, chandigarh-160012
Chandigarh
CHANDIGARH 
9872997438

ramawalia@rediffmail.com 
Dr Himanshu Prajapati  PHC Prajna Healthcare  Department of Clinical research, Room No. NA, 205-208, 2nd floor, Aagam Avenue, Nr Adani CNG Pump, Sabarmati, Ahmedabad, Gujarat 380005
Ahmadabad
GUJARAT 
9925075607

drhimanshupcr@gmail.com 
Dr Dhruvi Hasnani  RIMS Hospital  Department of Clinical research, Room No. NA, RIMS SUPERSPECIALITY HOSPITAL, 1ST FLOOR rupala complex, opp. Icici Bank, Near Ghodasar, Brts stop, Ghodasar, Ahmedabad, 380050.
Ahmadabad
GUJARAT 
8758485703

dhruvi.hasnani@gmail.com 
Dr Prabhat Agarwal  S. N. Medical College & Hospital  Department of Clinical research, Room No. NA, Near Moti kotra, Mantola, Agra, U.P 282003
Agra
UTTAR PRADESH 
9319250485

prabhatagrawal321@gmail.com 
Dr Hemant Phatale  SAMRAT ENDOCRINE INSTITUTE  Department of Clinical research, Room No. NA, 60, NEW ROKADIYA HANUMAN COLONY, CHATRAPATI SAMBHAJINAGAR, MUMBAI
Mumbai
MAHARASHTRA 
9823896796

hphatale@gmail.com 
Dr Ritesh Agrawala  Shanti Pawan Multispeciality Care  Department of Clinical research, Room No. NA, Plot No. 1128/2658, Jayadurganagar, Bomikhal, Bhubneswar, Odisha-751010- India
Khordha
ORISSA 
8480500080

drriteshagr@gmail.com 
Dr Kushal Banger  Shivam Hospital   Department of Clinical research, Room No. NA, Plot no -57, C.R.W CHS, Near MIDC,  water Tank, Kalyan road, Dombivli East, Mumbai 421201 Maharashtra, India
Mumbai
MAHARASHTRA 
9545664884

drkushal.bangar83@gmail.com 
DR Balbir Singh Kohli  Shree Pragati Foundations Hira Mongi Navneet Hospital  Department of Clinical research, Room No. NA, Shree Pragati Foundations Hira Mongi Navneet Hospital, Valji Ladha Road, Near Kalidas Natya Gruh, Mulund West, Mumbai-400080, Maharashtra, India
Mumbai
MAHARASHTRA 
9820471357

drbalbirk.hmnh@gmail.com 
Dr Ajay Agrawal  Sir Ganga Ram Hospital  Department of Clinical research, Room No. NA, SGRH Marg Rajinder Nagar, New Delhi-110060
New Delhi
DELHI 
9953055198

endocrinologist39@yahoo.co.in 
DR A Venkateshwar Rao  St. Theresas Hospital  Department of Clinical research, Room No. NA, St. Theresas Hospital, Sanathnagar, Hyderabad, Telangana-500018, India
Hyderabad
TELANGANA 
9440040662

venky_gmc@yahoo.co.in 
DR Dilip Shah  Suchak Hospital And Healthcare  Department of Clinical research, Room No. NA, 186, Manchubhai Road, Malad West), Mumbai-40 0 097, Maharashtra, India
Mumbai
MAHARASHTRA 
9820324286

drshahdilip@yahoo.co.in 
Dr Nitin Patankar  WISDOM CLINICS  Department of Clinical research, Room No. NA, WISDOM CLINCS , 201 SUPRIYA HEIGHTS , PK ROAD ( RHB ROAD JUNCTION ) , OPP BMC SCHOOL , NEAR KALIDAS , NATYAMANDIR , MULUND (WEST) MUMBAI 400080
Mumbai
MAHARASHTRA 
9821687783

npatankar@hotmail.com  
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 36  
Name of Committee  Approval Status 
ACEAS IEC (Creating New Knowledge with Ethics), Dr. Dhrumil Patel  Approved 
Altezza Institutional Ethis Coimmittee, Dr. Kushal Banger  Approved 
Anand surgical Hospital IEC, Dr. Henil Shah  Approved 
Aurangabad Health Care & Research LLP- Independent Ethics Committee, Dr. Hemant Phatale  Approved 
BSES Municipal General Ethics Committee, Dr. Manoj Chawla  Submittted/Under Review 
Chellaram Diabetes Institute-Institutional Ethics Committee, DR. A G Unnikrishnan  Approved 
ECRC-HEC, Dr. Dinesh Agarwal  Approved 
Ethics committee of Navmeet Memorial Hospital, Dr. Vaibhav Kothari  Approved 
Ethics Committee St. Theresas Hospital, DR A Venkateshwar Rao  Approved 
Good Society for Ethical Research, Dr. Pankaj Aneja  Approved 
IEC Maharaja Agrasen Hospital, Dr. Prabhat Kumar Sharma  Approved 
IEC Sparsh Hospotal and critical care Pvt. Ltd, Dr. Ritesh Agrawala  Approved 
INDIRA IVF HOSPITAL ETHICS COMMITTEE, Dr. Nitin Patankar  Approved 
INDIRA IVF HOSPITAL ETHICS COMMITTEE, Dr. Sharat Kolke  Approved 
Institute of Medical Education and Research, Dr. Rama Walia  Submittted/Under Review 
Institutional Ethics Committee Aatman Hospital, Dr Banshi Saboo  Approved 
Institutional Ethics Committee AIIMS Bathinda, Dr. Shivani  Submittted/Under Review 
Institutional Ethics Committee CARE Hospital, Dr. Bipin sethi  Approved 
Institutional Ethics Committee Hira Mongi Navneet Hospital, DR. Balbir Singh Kohli  Approved 
Institutional Ethics Committee, Deenanath Mangeshkar Hospital and research center, P, Dr. Vaishali Deshmukh  Approved 
Institutional Ethics Committee, Gandhi Medical College and Hospital, Dr. Vijay Sekhar Reddy  Approved 
Institutional Ethics Committee, Life Line Diagnostics Centre Cum Nursing Home, Dr Manojitketan Mukhopadhyay  Approved 
Institutional Ethics Committee, S. N. Medical College & Hospital, Dr. Prabhat Agarwal  Approved 
Kalinga Hospital Ethics Committee, Dr Mahesh Rath  Approved 
Kiran Hospital Ethics Committee, Dr. Nirav Shah  Approved 
Lakeview Ethics Committee, Dr Neeta Deshpande   Approved 
Medisys Clinisearch Ethical Review Board, Dr Paramesh Shamanna  Approved 
Oriion Criticare Hospital- Institutional Ethics Committee, Dr. Mayura Choudhari  Approved 
Riddhi Medical Nursing Home IEC, Dr. Himanshu Prajapati  Approved 
Rudraksh Hospital Ethics Committee, Dr. Dhruvi Hasnani  Approved 
S2J Independent Ethics Committee, Dr. K D Modi  Submittted/Under Review 
Sangini Hospital Ethics Committee, DR. Rizwan Ahmed Ansari  Approved 
Shah Lifeline Hospital And Heart Institute Ethics Committee, DR. Dilip Shah  Approved 
Shah Lifeline Hospital And Heart Institute Ethics Committee, Dr. Ketan Mehta  Approved 
Sir Gangaram Hospital Ethics Committee, Dr. Ajay Agrawal  Submittted/Under Review 
Zenith Institutional Ethics Committee, Dr Nikita Doshi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Semaglutide-Reference (R)  Dose Formulation: single-dose solution for injection in prefilled pen Unit Dose Strengths: Wegovy 0.25 mg FlexTouch (Semaglutide solution for injection in prefilled pen, 0.68 mg/mL, 1.5 mL), Wegovy 0.5 mg FlexTouch (Semaglutide solution for injection in prefilled pen, 1.34 mg/mL, 1.5 mL or 0.68 mg/mL, 3 mL), Wegovy 1 mg FlexTouch (Semaglutide solution for injection in prefilled pen, 1.34 mg/mL, 3 mL), Wegovy 1.7 mg FlexTouch (Semaglutide solution for injection in prefilled pen, 2.27 mg/mL, 3 mL), Wegovy 2.4 mg FlexTouch (Semaglutide solution for injection in prefilled pen, 3.2 mg/mL, 3 mL) Dosage Levels: Once weekly Timing of Dose: At any time of day, with or without meal Route of Administration: Subcutaneous Duration of Dose: 24 weeks 
Intervention  Semaglutide-Test (T)  Dose Formulation: single-dose solution for injection in pre-filled pen Unit Dose Strengths: Semaglutide Injection 0.68 mg/mL, 1.5 mL (0.25 mg dose) Semaglutide Injection 1.34 mg/mL, 1.5 mL (0.5 mg dose), Semaglutide Injection 1.34 mg/mL, 3 mL (1 mg dose), Semaglutide Injection 2.27 mg/mL, 3 mL (1.7 mg dose), Semaglutide Injection 3.2 mg/mL, 3 mL (2.4 mg dose) Dosage Levels: Once weekly Timing of Dose: At any time of day, with or without meal Route of Administration: Subcutaneous Duration of Dose: 24 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Must sign an ICF indicating that the participant understands the purpose of, and procedures
required for the study as described in Appendix 10.1.3 and in this protocol and is willing to
participate in the study.
2) Male or female participants with Age of 18 to 65 years (both inclusive) at the time of signing
the informed consent.
3) Body Mass Index (BMI) greater than or equal to 30 kg per m2 (Obese). OR BMI greater than or equal to 27 kg per m2 to less than 30 kg per m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease at screening assessment.
4) Participants with Type 2 diabetes mellitus should additionally meet the following: Glycosylated Haemoglobin (HbA1c) greater than or equal to 7.5 percentage and less than 10.5 percentage at screening assessment. Participants who are on a stable treatment with metformin, sulphonylurea (SU) or metformin plus SU for at least 90 days before screening along with diet and exercise control.
5) History of at least one self-reported unsuccessful dietary effort to lose body weight.
6) Willing to comply with the dietary and physical activity requirement during the study.
7) Contraceptive use by participants or participant’s partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) as defined in Appendix 4 OR Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly
effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency
when used consistently and correctly, as described in Appendix 4 during the intervention
period and for at least 2 months after the last dose of the study intervention. The
investigator should evaluate the effectiveness and the potential for contraceptive method
failure (e.g., noncompliance, recently initiated) of the contraceptive method in relation
to the first dose of the study intervention. A WOCBP agrees not to donate eggs (ova, oocytes), freeze them for future use for
reproduction or retrieve them for their use during the recommended period of
contraception. A WOCBP agrees to seek advice about donation and cryopreservation of
germ cells. A WOCBP must have a negative highly sensitive serum B-human chorionic
gonadotropin (BhCG) test at screening and urine BhCG test at Baseline. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from
participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are
located in section 8.3.5. The investigator is responsible for review of medical history, menstrual history, and recent
sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy.
8) Male participants are eligible to participate if they agree to the following during the intervention period and for at least 2 months after the last dose of study intervention: Must agree not to plan to father a child or donate sperm for reproduction; PLUS, either of the following: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent; OR Must agree to use contraception barrier as detailed below: a male participant must wear a condom when engaging in any activity that allows for the passage of ejaculate to another person With female partner use of an additional highly effective contraceptive method with a failure rate of less than 1 percentage per year as described in Appendix 4
9) The participant with adequate haematologic, liver renal function and other parameters as
mentioned below, at screening assessment.
a) Calcitonin less than or equal to 50 ng per L
b) Blood amylase less than or equal to 3 into ULN
c) Blood lipase less than or equal to 3 into ULN
d) Alkaline phosphatase less than or equal to 2 into ULN
e) Alanine aminotransferase less than or equal to 2 into ULN
f) Aspartate aminotransferase less than or equal to 2 into ULN
g) Total bilirubin less than or equal to 1.5 into ULN
h) Estimated glomerular filtration rate (eGFR) greater than 30ml per min per 1.73m2 as assessed by CKD-EPI 2021 equation including participants with end-stage renal disease
i) Haemoglobin greater than or equal to 9 g per dL
j) WBC count greater than or equal to 2500 per cu.mm
k) Neutrophil count greater than or equal to 1500 per cu.mm
l) Platelet count greater than or equal to 100,000 per cu.mm 
 
ExclusionCriteria 
Details  1) Known allergies, hypersensitivity, or intolerance to any of the study interventions & other GLP- 1 receptor agonists or components excipients thereof (refer to the SmPC of
Wegovy) or drug or other allergies that, in the opinion of the investigator, contraindicate
participation in the study.
2) Contraindications or limitations for administration of investigational intervention
according to SmPC of Wegovy.

Obesity related:

3) Treatment with any medication for the indication of obesity AND any medications affecting weight (other than oral contraceptives) within the past 90 days before screening.
4) A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.
5) Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (a) liposuction and or abdominoplasty, if performed greater than 1 year before screening, (b) lap banding, if the band has been removed greater than 1 year before screening, (c) intragastric balloon, if the balloon has been removed greater than 1 year before screening or (d) duodenal-jejunal bypass sleeve, if the sleeve has been removed greater than 1 year before screening.

Diabetes related:

6) 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 & treatment with GLP 1 RA within the past 180 days prior to screening.
7) Diagnosis of Type 1 diabetes.
8) Have a history of acute diabetic complications (diabetic ketoacidosis, lactic acidosis or
hyperosmolar hyperglycaemic state) within 6 months before screening.
9) History of proliferative retinopathy or diabetic macular oedema, or any other unstable retinopathy (rapidly progressive) recorded in medical history and may require treatment during the study.

Non-diabetic participants:

10) HbA1c greater than or equal to 5 percentage as measured at screening.

Mental health:

11) Suicidal ideation corresponding to a yes answer on Question 4 or 5 on the Suicidal
Thoughts portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days before screening.
12) History of major depressive disorder within 2 years before screening.
13) Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder).
14) Any lifetime history of a suicidal attempt.
15) Suicidal behaviour within 30 days before screening corresponding to a “yes” answer to any
of the suicide-related behaviours (actual attempt, interrupted attempt, aborted attempt,
preparatory act or behaviour) on the Suicidal Behaviour portion of the C-SSRS.
16) Patient Health Questionnaire-9 (PHQ-9) score of greater than or equal to 15 at screening.

General safety:

17) Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to
the first dose of investigational intervention.
18) Positive hepatitis C antibody test result at screening or within 3 months prior to the first
dose of investigational intervention.
19) Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.
20) Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid
carcinoma. Family is defined as a first degree relative.
21) Participants with a history of acute chronic pancreatitis
22) Participants with known alcohol or other substance abuse within last 1year of screening.
23) History or presence of malignancy within the past 5 years except for adequately treated
cervical carcinoma in situ, basal cell or squamous cell skin cancer.
24) Participant with uncontrolled hypertension with sitting systolic BP greater than or equal to 160 mmHg and per or diastolic BP greater than or equal to 100 mmHg at screening.
25) Participant with clinically significant current or recent (within the past 60 days prior to screening) cardiac conditions as defined below:
a) Acute coronary syndrome, stroke [including transient ischemic attack (TIA)] or other
ischemic event or thromboembolic event [e.g., deep vein thrombosis (DVT), pulmonary
embolism]
b) Clinical risk assessment of cardiac function using the New York Heart Association
Functional Classification of Class III & IV26
26) Received any other investigational intervention or used an invasive investigational medical
device within 3 months or 5 half-lives prior to the first dose of study intervention,
whichever is longer.
27) Previous treatment with semaglutide.
28) Participants with medication history of herbal non-herbal medicine with unknown
unspecified content within 90 days.
29) Participants with any abnormality on 12-lead ECG at screening that in the opinion of the Investigator is clinically significant and is judged as potential risk for his her participation in the study.
30) Surgery scheduled for the duration of the study, except for minor surgical procedures, in the opinion of the investigator.
31) Participation in another clinical study within 90 days before screening.
32) Documented medical history of uncontrolled, clinically significant intercurrent medical
condition(s) for which, in the opinion of the investigator, participation would not be in the
best interest of the participant (e.g., compromise the well-being) or that could prevent, limit,
or confound the protocol-specified assessments.
33) Other causes of obesity can be excluded with documented history or known case of other
endocrine diseases, including hypothalamic obesity, pituitary obesity, Cushings syndrome,
acromegaly, hypogonadism etc.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To establish non-inferiority of semaglutidetest
compared to semaglutide-reference in
overweight and obese adult participants in
adjunct to diet and exercise 
Percent change in the body weight from
baseline to Week 24 
 
Secondary Outcome  
Outcome  TimePoints 
To establish non- inferiority of Semaglutide-
Test compared to semaglutide-reference in
overweight & obese adult participants in
adjunct to diet & exercise 
a) Percent change in body weight from baseline to Week 4, 8, 12, 16 & 20
b) Mean change in absolute body weight from
baseline to Week 4, 8, 12, 16, 20 & 24.
c) Percentage of participants who achieve greater than or equal to 5 percentage, greater than or equal to 10 percentage body weight loss at Week 4, 8, 12, 16 & 24
d) Mean change in BMI from baseline to Week 4, 8, 12, 16, 20 & 24
e) Mean change in body waist circumference (cm) from baseline to Week 4, 8 12, 16, 20 & 24 
To evaluate safety of semaglutide-test
compared to semaglutide-reference in
overweight and obese adult participants in
adjunct to diet and exercise 
Percentage of participants experiencing TEAE 
To evaluate immunogenicity of
semaglutide-test compared to semaglutidereference
in overweight & obese adult
participants in adjunct to diet & exercise 
Proportion of participants with anti-drug
antibodies (ADA) & neutralizing antibody
(NAb) [Timeframe: Baseline (Pre-dose), Week
12, 20 & 24] 
 
Target Sample Size   Total Sample Size="264"
Sample Size from India="264" 
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)   02/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  
This is a study to Investigate the Efficacy and Safety of Semaglutide of Intas Compared to Wegovy FlexTouch in Overweight and Obese Adult Participants in Adjunct to Diet and Exercise.
 
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