CTRI

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CTRI Number

CTRI/2025/07/092006 [Registered on: 30/07/2025] Trial Registered Prospectively

Last Modified On:

18/09/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Effectiveness of Injection Semaglutide in Overweight or Obesity

Scientific Title of Study

A Prospective, Randomized, Multicentric, Open Label, Active Controlled, Parallel Group Study to Compare the Efficacy, Safety and Immunogenicity of Once-Weekly Hetero-Semaglutide with RMP-Semaglutide (WegovyTM, Novo Nordisk) in Adults with Overweight or Obesity.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
HCR/III/SEMAOBE/01/2025, Version;1.0, Date;16/01/2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Shubhadeep Sinha
Designation	Senior Vice President and Head
Affiliation	Hetero Labs Limited
Address	7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad Hyderabad TELANGANA 500018 India
Phone	04023704923
Fax
Email	sd.sinha@hetero.com

Details of Contact Person
Scientific Query

Name	Dr Sreenivasa Chary S
Designation	Senior General Manager
Affiliation	Hetero Labs Limited
Address	7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad Hyderabad TELANGANA 500018 India
Phone	04023704923
Fax
Email	Sreenivasa.Chary@hetero.com

Details of Contact Person
Public Query

Name	Mohan Reddy Bandi
Designation	General Manager
Affiliation	Hetero Labs Limited
Address	7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad Hyderabad TELANGANA 500018 India
Phone	04023704923
Fax
Email	B.MohanReddy@hetero.com

Source of Monetary or Material Support

Hetero Labs Limited, 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad, TELANGANA, 500018, India

Primary Sponsor

Name	Hetero Labs Limited
Address	7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad, 500018, TELANGANA, India
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 37
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Viswa prasad V	Abhayahasta Multispeciality Hospital	Department General Medicine, Ground Floor, Katha No. 347/247 2nd CrossKaggadasapura Main Road, CV Raman Nagar-560093 India Bangalore KARNATAKA	9448278422 cr@abhayahastahospital.com
Dr Anand Vishal	ABVIMS, Dr. Ram Manohar Lohia Hospital	Department of Endocrinology, Room No 301, 3rd Floor, Baba Kharak Singh Marg -110001, India" New Delhi DELHI	9319803331 dranandvishal21@gmail.com
Dr Noushad Ali	ACSR Government Medical College and Hospital	Department of General Medicine, First Floor, Room No 11, GT Road-524004, India Nellore ANDHRA PRADESH	949428694 mddbnoal@gmail.com
Dr Sachin Dethe	Altiuz Multispeciality Hospital & Research Centre	Department of General Medicine, Research Room, 1st floor, Link House, Link Road, Chincholi, Malad-400064, India. Mumbai MAHARASHTRA	09322532803 drsachin197818@yahoo.in
Dr Siddharth Jain	Bandari Hospital & Research Centre	Department of General Medicine, Clinical research Room, Ground Floor 138-A, Vasundhara Colony, Gopalpura, Bypass, Tonk Road -302018, India. Jaipur RAJASTHAN	9929405777 contact@bhandarihospital.net
Dr Deepak Gargi Pande	Dr. B.L.Kapur Memorial Hospital	Department of General Medicine, Room No 28, Ground Floor, Pusa Road-110005, India" New Delhi DELHI	09818802981 doctorsblkkcr@gmail.com
Dr Tinkal C Patel	Dr.M.K.Shah Medical College and Research Centre & Smt SMS Multispeciality Hospital	Department of Medicine, Room No 3 Blcok B, Ground Floor, Near Tapovan Circle, Visat-Gandhinagar, Highway, Chandkheda- 382424, India" Ahmadabad GUJARAT	9898713223 drmkshahmc@gmail.com
Dr L Suneel Kumar	Gandhi Hospital	Department of Medicine, 2nd Floor, Room No 01, Inpatient Block Musheerabad, Secunderabad, Telangana-500003, India. Hyderabad TELANGANA	9000976655 drsunil@gmail.com
Dr K Sunil Naik	Government Medical College and Govt.General Hospital (Old RIMSGGH)	Department of General medicine, Room No, 13, First Floor -532001, India Srikakulam ANDHRA PRADESH	09440828299 drsunilnaikggh@gmail.com
Dr Gandhi Parise	Govt. Siddhartha Medical College	Department of General Medicine Room No.9 Ground Floor, Ring Road, Gunadala, Vijayawada-520008, India Krishna ANDHRA PRADESH	9492732771 parisegandhi34@gmail.com
Dr Sanket Chetanbhai Mathukiya	Hi Tech Multispeciality Hospital	Department of General Medicine, Room No 04, Ground Floor, Sector 3-D, Plot No. 1180, Gh Road, Near Gh-1 ½ Bus Stand-382003, India. Gandhinagar GUJARAT	09953214322 drsanketmathukiya16@gmail.com
Dr Anil Samaria	Jawahar Lal Nehru Medical College	Department of Medicine, Ground Floor, Room No.99, Kala Bagh-305001, India. Ajmer RAJASTHAN	09414008246 dr.anilsamaria@outlook.com
Dr Biswaroop Mukherjee	Kasturi Das Memorial Superspeciality Hospital	Department of General Medicine, Room No 2, Ground Floor A Unit of Dishari Health Point Pvt Ltd, Holding No-B1-38/1/New Santoshpur, Block-B, Road Bye Lane-1, P.O.- Santoshpur (M), P.S.- Maheshtala - 700142, India. Kolkata WEST BENGAL	9830839636 bm.clinicaltrial@gmail.com
Dr Polupoina Sreenivasulu	Kurnool Medical College, Govt General Hospital	Departmentof Endocrinology, 2nd Floor, Room No 1 Floor Room No Budhawara Peta-518002, India " Kurnool ANDHRA PRADESH	9849629360 sreenivassendo@gmail.com
Dr Prabhat Kumar	Maharaja Agrasen Superspeciality Hospital	Department of Medicine, Ground Floor, Room No 2, Central Spine, Agrasen Aspatal Marg, Sector7, Vidyadhar Nagar-302039, India" Jaipur RAJASTHAN	9983995050 pksharma.clinical@gmail.com
Dr B Thrilok Chander	Mahatma Gandhi Memorial Hospital	Department of General Medicine, Room No 1, Second Floor-506002, India. Warangal TELANGANA	09160860777 thrilok73@gmail.com
Dr Nithya Chandra	Malla Reddy Narayana Multispeciality Hospital	Department of General Medicine Room No 1, Ground Floor, Suraram X Roads, Jeedimetla-500055, India. Hyderabad TELANGANA	9885429751 dr.nithyachandra@gmail.com
Dr Abhishek Prakash	Manglam Plus Medicity Hospital	Department of Endocrionology, Room No.601, 6th Floor, Sector 05, Shipra Path, Mansarovar-302020 India Jaipur RAJASTHAN	9680040978 drmkshahmc@gmail.com
Dr Anirban Sinha	Medical College and Hospital Kolkata	Department of Endocrinology, Clinical Research Room, Fourth Floor, Kolkata 88, College Street -700073, India. Kolkata WEST BENGAL	09830160050 Anirban.doc@gmail.com
Dr Subhash Kumar	Medipulse Hospital	Department of Endocrinology, Clinical research department, Lower Ground Floor, E4, MIA Basni II Phase, Opposite AIIMS Link Road-342005, India Jodhpur RAJASTHAN	07300454987 endocrineacademic2020@gmail.com
Dr Sirshendu Pal	Mitras Multispeciality Hospital	Department of General Medicine Room No 3, Ground Floor, 1 Tilak Road Ward -12, Hakim para, Siliguri-734001, India Darjiling WEST BENGAL	09474875556 info@hamsindia.com
Dr Nutan Kumar Agrawal	MLB Medical College and Associated Hospital	Department of Medicine, Ground Floor, Room No.138, Kanpur Road-284128, India. Jhansi UTTAR PRADESH	9839789378 dr_nutan_agrawal@yahoo.com
Dr Kaushalendra Nath Tripathi	Motilal Nehru Medical College & Associate Swarooprani Nehru Hospital	Department of General Medicine, Room No 3, Ground Floor, Swarooprani Nehru Hospital, Prayagraj-211002, India. Varanasi UTTAR PRADESH	07007486535 kaushlendranathtripathi@gmail.com
Dr Ramanbhai Gamabhai Patel	Namostute Hospital	Department of General Medicine Room No 105, First Floor, Plot No-1285, Sector 6-D, GH-3 circle, Opposite Civil Hospital-382006, India Gandhinagar GUJARAT	09898205641 drramanpatel22@gmail.com
Dr Badal Kumar Sahu	Nil Ratan Sircar Medical College and Hospital	Department of General Medicine, 5th Floor, Room No 4, 138, AJC Bose Road-700014, India Kolkata WEST BENGAL	824018543 drbadal08@gmail.com
Dr Deo Nidhi Mishra	Nirmal Hospital	Department of General Medicine Room No 1, Devalaya, Ground Floor, Opp. MLB Medical College, Gate No 3-284128, India. Jhansi UTTAR PRADESH	09415031689 drmishra.nirmal@gmail.com
Dr K Neelaveni	Osmania Medical College & Osmania General Hospital	Department of Endocrinology, 2nd Floor, Room No 306, Golden Jubilee Block, Afzalgunj-500012, India Hyderabad TELANGANA	9848131182 neelaveni1@yahoo.co.in
Dr Ashu Rastogi	Postgraduate Institute of Medical Education &Research (PGIMER)	Department of Endocrinology, Nehru Extension, Ground Floor, Room No 16, Sec-12-160012, India" Chandigarh CHANDIGARH	9781001046 ashuendo@gmail.com
Dr Parth Dineshbhai Patel	Rhythm Hospital	Department of General Medicine Room No 01, Second Floor, D-201, SF Fortune Atlantis, Kudasan,382421, India Gandhinagar GUJARAT	8780089653 info@therhythmhospital.com
Dr Veer Bahadur Singh	Sardar Patel Medical College and AG Hospitals	Department of General Medicine Room No 01, Ground Floor, Sardar Patel Colony-334001 India Bikaner RAJASTHAN	09414136888 Vbsingh2@rediffmail.com
Dr Shalin J Shah	Sheth Vadilal Sarabhai General Hospital and Sheth Chinai Maternity Hospital	Department of Endocrinology 2nd Floor, Research wing Room No. 201, Elliss bridge-380006, India Ahmadabad GUJARAT	9924071369 drshalinjshah@gmail.com
Dr Sanjay Saran	SMS Medical College and Hospital	Department of Endocrinology, Room No-43A, Fourth Floor, Dhanvantri OPD Block-302004, India Jaipur RAJASTHAN	09760190799 drsanjaysaran@gmail.com
Dr Prabhat Kumar	SN Medical College	Department of Medicine, Ground Floor,Room No 12, Near Central Library, Moti Katra Mantola- 282003, India Agra UTTAR PRADESH	9319250485 prabhatagrawal321@gmail.com
Dr Ronak Gandhi	SN Medical College, Mathuradas Mathur Hospital	Department of Endocrinology, Room No 102, Ground Floor, Residency Road, Shashtri Nagar-342003, India. Jodhpur RAJASTHAN	9001324190 sonu.ronak@gmail.com
Dr A Venkateshwar Rao	St. Theresa’s Hospital	Department of General Medicine Room No 3, Ground Floor Sanathnagar,500018, India. Hyderabad TELANGANA	9440040662 drvenkateshwarraoavula@gmail.com
Dr Nitin Parikh	Trisha Multispeciality Hospital	Department of General Medicine, Room No 5, 6Th Floor Dream Square, Chandlodia Rd Bridge, Akhbar Nagar, Nirnay Nagar, 380013, India Ahmadabad GUJARAT	09825412828 drncp2007@yahoo.co.in
Dr Baratam Hari Kiran	Visakha Institute of Medical Sciences (VIMS)	Department of Endocrinology Room No 11, Ground Floor, Hanumanthawaka-530040, India Visakhapatnam ANDHRA PRADESH	09959682999 drbharikiranresearch@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 37
Name of Committee	Approval Status
ABVIMS, Dr. Ram Manohar Lohia Hospital	Submittted/Under Review
Dr. B.L.Kapur Memorial Hospital Ethics Committee. Dr. B.L.Kapur Memorial Hospital	Submittted/Under Review
Ethicare Ethics Committee	Submittted/Under Review
Ethics Committee NRS Medical College	Submittted/Under Review
Ethics Committee Rhythm Hospital	Approved
Ethics Committee SMS Medical College and Attached Hospitals	Submittted/Under Review
Ethics Committee St. Theresa’s Hospital	Approved
Ethics Committee, Siliguri Sumita Cancer R.W and E Society	Submittted/Under Review
Ethics Committee, SP Medical College	Approved
Hi-Tech Ethics Committee Hi Tech Multispeciality Hospital	Approved
IEC Manglam Medicity Hospital	Approved
IEC, Maharaja Agrasen Hospital	Approved
Institutional Ethics Committee Aatman Hospital, Aatman Hospital	Submittted/Under Review
Institutional Ethics Committee Kurnool Medical College /Govt General Hospital	Submittted/Under Review
Institutional Ethics Committee Aatman Hospital	Approved
Institutional Ethics Committee ACSR Government Medical College and Hospital	Approved
Institutional Ethics Committee Bandari Hospital & Research Centre	Submittted/Under Review
Institutional Ethics Committee Dr. M.K. Shah Medical College and Research Centre	Submittted/Under Review
Institutional Ethics Committee Dr. S.N. Medical College	Submittted/Under Review
Institutional Ethics Committee for Human Research Kolkata	Submittted/Under Review
Institutional Ethics Committee Government General Hospital	Approved
Institutional Ethics Committee Kakatiya Medical College	Submittted/Under Review
Institutional Ethics Committee Malla Reddy Medical College for women	Approved
Institutional Ethics Committee Medipulse Hospital	Approved
Institutional Ethics Committee Nirmal Hospital	Approved
Institutional Ethics Committee PGIMER	Submittted/Under Review
Institutional Ethics Committee S.N Medical College	Submittted/Under Review
Institutional Ethics Committee Shashvat Surgicare Hospital	Approved
Institutional Ethics Committee SMC and GGH Govt. Siddhartha Medical College	Approved
Institutional Ethics Committee, Abhayahasta Superspeciality Hospital	Approved
Institutional Ethics Committee, Gandhi Medical/Hospital College	Approved
Institutional Ethics Committee, Jawahar Lal Nehru Medical College	Approved
Institutional Ethics Committee, Kasturi Das Memorial Superspeciality Hospital	Approved
Institutional Ethics Committee, MLB Medical College	Submittted/Under Review
Institutional Ethics Committee, Motilal Nehru Medical College	Approved
Institutional Ethics Committee, Osmania Medical College	Approved
Institutional Ethics Committee, Visakha Institute of Medical Sciences (VIMS)	Approved

Regulatory Clearance Status from DCGI
Modification(s)

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	Hetero-Semaglutide	A prefilled pen injector once weekly (on the same day each week) as subcutaneous injection in abdomen, thigh or upper arm. Th initial dose will be 0.25 mg weekly for the first 4 weeks followed by fixed dose escalation regimen, with dose escalation every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until it reaches the maintenance dose (target dose) of 2.4 mg weekly by week 16.
Comparator Agent	RMP-Semaglutide, Novo Nordisk	A prefilled pen injector once weekly (on the same day each week) as subcutaneous injection in abdomen, thigh or upper arm. Th initial dose will be 0.25 mg weekly for the first 4 weeks followed by fixed dose escalation regimen, with dose escalation every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until it reaches the maintenance dose (target dose) of 2.4 mg weekly by week 16.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Subjects of either gender, aged greater than or equal to 18 years to less than or equal to 65 years. 2. Body mass index (BMI) greater than or equal to 27 kg per meter square to less than 30 kg per meter square with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnoea, cardiovascular disease or dysglycemia (prediabetes or type 2 diabetes mellitus) OR greater than or equal to 30 kg per meter square with or without comorbidities at screening and randomization 3. For T2DM Subjects at screening: a. T2DM diagnosed greater than or equal to 180 days prior to screening b. T2DM subjects on stable dose on metformin for at least greater than or equal to 90 days prior to screening c. T2DM subjects with HbA1C 8 percentage-10 percentage

ExclusionCriteria

Details

1. History of type 1 diabetes mellitus
2. Known/current diabetic retinopathy in patients with type 2 diabetes.
3. Treatment with glucose-lowering agent(s) agents which can result in weight gain (such as insulin, Thiazolidinediones, Sulfonylureas) or weight loss (SLT2i, dual GIP-GLP RA) prescribed for the indication of diabetes mellitus within 90 days before screening.
4. Treatment with any medication prescribed for the indication of obesity or
weight management within 90 days before screening
5. Previous or planned (during the study period) obesity treatment with surgery or a weight loss device.
6. Hamilton Depression Rating Scale (HAM-D) greater than or equal to total item score 10 or greater than or equal to 2 on suicide item on HAM-D -17 item scale at screening.
7. Subjects with the following laboratory abnormalities at screening
a. Alanine aminotransferase (ALT) greater than or equal to 3×ULN
b. Aspartate aminotransferase (AST) greater than or equal to 3×ULN
c. Total bilirubin (TBiL) greater than or equal to3×ULN
d. Serum Calcitonin greater than 50ng/L
e. Serum amylase greater than or equal to 3×ULN
f. Serum lipase greater than or equal to 3×ULN
g. Serum creatinine greater than or equal to 1.5 mg per dL in males or greater than or equal to 1.4 mg per dL in females

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Centralized

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Mean percentage reduction in body weight	Baseline to 24 weeks

Secondary Outcome

Outcome	TimePoints
Proportion of subjects with body weight reduction of at least 5%	At 12 and 24 weeks
Proportion of subjects with body weight reduction greater than or equal to 10%	At 12 and 24 weeks
Proportion of subjects with body weight reduction greater than or equal to 15%	At 12 and 24 weeks
Mean change in waist circumference (cm)	Baseline to 12 and 24 weeks
Mean change in waist hip ratio (WHR)	Baseline to 12 and 24 weeks
Mean change in body mass index (BMI) (kg per meter square)	Baseline to 12 and 24 weeks
Mean change in systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg)	Baseline to 12 and 24 weeks
Mean change in total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol and triglycerides	Screening to 12 and 24 weeks
Mean change in glycated hemoglobin (HbA1c) in type 2 diabetes mellitus (T2DM) subjects	Screening to 12 and 24 weeks
Mean change in fasting plasma glucose (FPG) and post prandial plasma glucose (PPG) in T2DM subjects	Baseline to 4, 8, 12, 16, 20 and 24 weeks
Change in quality of life by short form survey (SF-36) scores	Baseline to 12 and 24 weeks
Proportion of subjects with anti-drug antibody ADA) to Semaglutide	Baseline to 12 and 24 weeks
Treatment emergent adverse events by monitoring significant clinical signs, symptoms and laboratory abnormalities	All visits

Target Sample Size

Total Sample Size="258"
Sample Size from India="258"
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)

11/08/2025

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="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

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 Prospective, Randomized, Multicentric, Open Label, Active Controlled, Parallel Group Study to Compare the Efficacy, Safety and Immunogenicity of Once-Weekly Hetero-Semaglutide with RMP-Semaglutide (WegovyTM, Novo Nordisk) in Adults with Overweight or Obesity. A total of 258 patients randomized in 1:1 ratio (i.e., 129 in Hetero-Semaglutide vs 129 in RMP-Semaglutide). who are overweight with BMI greater than or equal to 27 kg per meter square to less than 30 kg per meter square with comorbidities or obese subjects with BMI greater than or equal to 30 kg per meter square with or without comorbidities who will meet all the inclusion criteria and none of the exclusion criteria will be enrolled in this study. Subject will be administered with Hetero-Semaglutide / RMP-Semaglutide (Wegovy, Novo Nordisk), a prefilled pen injector once-weekly (on the same day each week) as subcutaneous injection in abdomen, thigh or upper arm. The initial dose will be 0.25 mg once weekly for the first 4 weeks followed by fixed-dose escalation regimen, with dose escalation every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week), until it reaches the maintenance dose (target dose) of 2.4 mg weekly by week 17. Subjects will be instructed to inject the trial product(s) subcutaneously once weekly in the abdomen, thigh, or upper arm. Subjects will also be required to follow dietary restrictions during the study. Total study duration per patient is 30 weeks (maximum), consists of 2 weeks screening period, 24 weeks of treatment period and followed by 4 weeks of post treatment safety follow up.