CTRI/2025/03/082620 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On:
20/11/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical study to evaluate the efficacy and safety of Semaglutide Injection in patients with weight management.
Scientific Title of Study
A Multicenter, Randomized, Comparative, Active-Controlled, Open label, Phase 3 Study to Evaluate the Efficacy and Safety of Semaglutide Injection in Comparison with Reference Biologic in Obesity Management.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT/2024/32, Version No.: 01 and Date Feb 14, 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Deven V Parmar
Designation
Chief Medical Officer and Head Clinical R & D
Affiliation
Zydus Lifesciences Limited
Address
Zydus Research Centre, Sarkhej - Bavla N.H. No.8A, Moraiya.
Ahmadabad GUJARAT 382213 India
Phone
02717665555
Fax
Email
dparmar@zydustherapeutics.com
Details of Contact Person Scientific Query
Name
Dr Kevinkumar Kansagra
Designation
Senior General Manager - Clinical R & D
Affiliation
Zydus Lifesciences Limited
Address
Zydus Research Centre, Sarkhej - Bavla N.H. No.8A, Moraiya.
Ahmadabad GUJARAT 382213 India
Phone
02717665555
Fax
Email
kevinkumarkansagra@zyduslife.com
Details of Contact Person Public Query
Name
Dr Hardik Pathak
Designation
General Manager - Clinical R & D
Affiliation
Zydus Lifesciences Limited
Address
Zydus Research Centre, Sarkhej - Bavla N.H. No.8A, Moraiya.
Ahmadabad GUJARAT 382213 India
Phone
02717665555
Fax
Email
Hardik.L.Pathak@zyduslife.com
Source of Monetary or Material Support
Zydus Lifesciences Limited, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar Highway, Ahmedabad-382481, Gujarat, India.
Primary Sponsor
Name
Zydus Lifesciences Limited
Address
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar Highway, Ahmedabad-382481, Gujarat, India.
Motilal Nehru Medical College & Associate Swarooprani Nehru Hospital
Department of Medicine, Prayagraj-211001.
Allahabad UTTAR PRADESH
7007486535
kaushalendranaththripathi@gmail.com
Dr Varun Bafna
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and CPR General Hospital
Department of Medicine, Dasara Chowk, Town Hall, Bhausingji Road, Kolhapur-416012.
Kolhapur MAHARASHTRA
7969792775
varunbafna07@gmail.com
Dr Kalyan Kumar Das
Aastha Hospital
Research Room, Beside NBMCH, Opp. Bharat Petrol Pump, Kawakhari, Siliguri-734012.
Darjiling WEST BENGAL
9821275226
Aastha.clinical@gmail.com
Dr Chintan B Patel
Aatman Hospital
Research Room, 5, Anveshan Row House, Opp. Umiya Mata Mandir, Bopal-Ghuma Main Road, Bopal, Ahmedabad-380058. Ahmadabad GUJARAT
9825182251
drchintan.cr@gmail.com
Dr Patel Manan Bharatkumar
Ananta Multispecilaity Hospital
Research Room, 4th Floor (416-418) Centre Point, Opp. Vrundavan Heights, Vande Mataram City to Savvy Swaraj Road, Chenpur, Gota, Ahmedabad-382470. Ahmadabad GUJARAT
9898377498
patelmanan15190@yahoo.com
Dr M Swapna
Gandhi Hospital
In Patient Block, 3rd Floor, Department of General Medicine, Musheerabad, Secunderabad-500003. Hyderabad TELANGANA
9885144447
drswapna999@gmail.com
Dr Budithi Sudarsi
Government Medical College, Government General Hospital
Department of General Medicine, Cantonment, Vizianagaram-535003. Vizianagaram ANDHRA PRADESH
9550845095
drbsudarsiresearch@gmail.com
Dr Kanugula Sudheer
Great Eastern Medical School and Hospital
Research Room, Ragolu, Srikakulam-532484. Srikakulam ANDHRA PRADESH
9666123122
drksudheeresearch@gmail.com
Dr S K Gautam
GSVM Medical College
Post Graduate Department of Medicine, LLR Hospital, Swaroop Nagar, Kanpur-208002.
Kanpur Nagar UTTAR PRADESH
0512-2535483
dr.gautamhal@gmail.com
Dr Ansari Rizwanahmed Nurulhasan
Hope Well Medical Hospital
Research Room, Block G, 1st Floor, 101, 102, Sumel-8, Nr. Ajit Mill Char Rasta, Rakhiyal, Ahmedabad-380023. Ahmadabad GUJARAT
9033884736
drrizwanansari@yahoo.com
Dr Surya Veeramani Kartheek Adhikarla
King George Hospital
Department of General Medicine, Rajendra Prasad Ward, Maharanipeta, Visakhapatnam-530002.
Visakhapatnam ANDHRA PRADESH
9703586435
drasvkartheekresearch@gmail.com
Dr Gouranga Sarkar
Life Line Diagnostic Centre cum Nursing Home
Research Room, 4A, Wood Street, Kolkata-700016. Kolkata WEST BENGAL
891023595
drgsmed@gmail.com
Dr Prabhat Kumar Sharma
Maharaja Agrasen Superspeciality Hospital
Research Room, Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur-302039. Jaipur RAJASTHAN
9983995050
Pksharma.clinical@gmail.com
Dr Shravan Kumar Ankathi
Mahatma Gandhi Memorial Hospital
Research Room, Sherpura, Warangal-506002.
Warangal TELANGANA
9985579753
drshravanankathi.krcwgl@gmail.com
Dr Raja Bhattacharya
Medical College and Hospital
Department of Medicine, MCH Building, 2nd Floor, 88 College Street, Kolkata-700073.
Kolkata WEST BENGAL
8100273048
rbrbhattacharya@gmail.com
Dr Sumit Anand
NIMS Heart and Brain Hospital
Research Room, B28, 29, Govind Marg, Raja Park, Jaipur-302004. Jaipur RAJASTHAN
9929082000
nhbh.clinical@gmail.com
Dr Vijaykumar Shivajirao Patil
Prakash Institute of Medical Sciences & Research
Research Room, Urun-Islampur, Islampur-Sangali Road, Islampur, Tal-Walwa, Sangli-415409.
Sangli MAHARASHTRA
9371877555
mangovijay@gmail.com
Dr Sagar Vivek Redkar
Redkar Hospital and Research Centre
Research Room, Mumbai-Goa Highway, Oxelbag, Dhargal, Tal-Pernem, Goa-403513.
North Goa GOA
7969792769
redkardr.sagar@gmail.com
Dr Veer Bahadur Singh
Sardar Patel Medical College & A.G. Hospitals
Department of Medicine, Sardar Patel Colony, Bikaner-334001. Bikaner RAJASTHAN
9414136888
vbsingh2@rediffmail.com
Dr Shalin J Shah
Sheth Vadilal Sarabhai General Hospital & Sheth Chinai Maternity Hospital
Institutional Ethics Committee, Motilal Nehru Medical College
Approved
Institutional Ethics Committee, Visakha Institute of Medical Sciences (VIMS)
Approved
Kakatiya Institutional Ethics Committee, Kakatiya Medical College - Mahatma Gandhi Memorial Hospital
Approved
Prakash Medical College Institutional Ethics Committee, Prakash Institute of Medical Sciences & Research (PIMS&R)
Approved
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College Institutional Ethics Committee 2 (RCSMGMCIEC2), Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital
Approved
Redkar Hospital Institutional Ethics Committee (RHIEC), Redkar Hospital and Research Centre
Reference product will be administered once weekly at any time of day, with or without meals for 24 weeks. Injection will be administered subcutaneously in the abdomen, thigh, or upperarm.
Intervention
Semaglutide Injection 15 mg/3 mL (5 mg/mL)
Test product will be administered once weekly at any time of day, with or without meals for 24 weeks. Injection will be administered subcutaneously in the abdomen, thigh, or upperarm.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1. Male or female, aged 18 to 75 years (both inclusive) at the time of signing informed consent.
2. Patients with 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).
3. Patients with a history of at least one self-reported unsuccessful dietary effort to lose body weight.
4. Patients willing to comply with the dietary and physical activity requirement during the study.
5. 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] hormonal contraception, intrauterine devices, intrauterine hormone releasing system, bilateral tubal occlusion, or total sexual abstinence).
6. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
7. Patients willing to comply with the protocol requirements.
Inclusion Criteria Applicable for Type 2 Diabetes Mellitus Patients:
8. Patients with glycosylated haemoglobin (HbA1c) 7.0% - 10.0% (both inclusive) at screening visit.
9. Patients diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening.
10. Patients who are on a stable treatment with up to three oral glucose-lowering agents (Metformin, sulfonylureas, SGLT2 inhibitors, or Thiazolidinediones for at least 90 days before screening along with diet and exercise control.
ExclusionCriteria
Details
1. Patients with a history of type 1 diabetes mellitus.
2. Treatment with a GLP-1 receptor agonist (GLP-1 RA) within 180 days before screening.
3. Treatment with Semaglutide previously.
4. A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.
5. Treatment with any medication for the indication of obesity
within the past 90 days before screening.
6. 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.
7. Patients with uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) greater than 6.0 mIU/L or less than 0.4 mIU/L.
8. Patients with a history of major depressive disorder within 2 years before screening.
9. Patients with a history of or diagnosis of other severe
psychiatric disorder (e.g., schizophrenia, bipolar disorder etc.).
10. A lifetime history of a suicidal attempt.
11. Patients with a history of suicidal behaviour or suicidal ideation within 30 days before screening.
12. Patients having Hamilton Depression Rating Scale (HAM-D; 17 items) total score greater than or equal to 10, and/or a score of greater than or equal to 2 on Suicide item of
HAM-D 17-items scale at screening.
13. Patients with the use of any herbal/ non-herbal medicine with unknown/unspecified content within 90 days before screening.
14. Patients with a history or presence of pancreatitis.
15. Calcitonin greater than or equal to 50 ng/L at screening.
16. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
17. Renal impairment measured as estimated glomerular filtration rate (eGFR) value of eGFR less than 30ml/min/1.73 m2 [Note: estimated glomerular filtration rate (eGFR) will be calculated using Modification of Diet in Renal Disease (MDRD) formula].
18. Patients with aspartate transaminase [AST] greater than 1.5 x upper limit of normal [ULN] OR alanine transaminase [ALT] greater than 1.5 x ULN OR alkaline phosphatase [ALP] greater than 1.5 x ULN OR total bilirubin greater than 1.5 x ULN) at screening.
19. Patients with a 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.
20. Patients with a history of myocardial infarction, stroke or hospitalization for unstable angina or transient ischaemic attack within the past 60 days prior to screening.
21. Patients with a presence of heart failure classified as being in New York Heart Association (NYHA) Class II, III and IV.
22. Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator.
23. Patients with known or suspected abuse of alcohol or recreational drugs.
24. Patients with known or suspected hypersensitivity to trial
product(s) or related products.
25. Patients with participation in another clinical trial within 90 days before screening.
26. 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.
27. Patients with 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:
28. Patients with glycosylated haemoglobin (HbA1c) greater than or equal yo 6.5% as measured at screening.
29. Treatment with glucose-lowering agent(s) within 90 days before screening.
Exclusion Criteria for Diabetic Patients:
30. Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria (up to three oral glucose-lowering agents, i.e., Metformin, sulfonylureas, SGLT2 inhibitors, or Thiazolidinediones within the past 90 days prior day of screening.
31. Present or past history of uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Percentage change in body weight from baseline to week 24.
Baseline and Week 24.
Secondary Outcome
Outcome
TimePoints
Percentage change in body weight from baseline to week 4, 8, 12, 16 and 20.
For Non-diabetic patients
Change in glycosylated hemoglobin, FPG & PPG from baseline to week 24.
Baseline and Week 24.
Adverse events & Serious adverse events (SAE) reported during the study.
Throughout the study.
Number of patients discontinued due to AEs during course of trial.
Throughout the study.
Number of patients requiring hypoglycaemia management (for diabetic patients only).
Throughout the study.
Proportion of patients with anti-drug antibodies (ADA) and Neutralizing Antibody (Nab) at week 24 compared to pre-dose (enrolment, Day 0 - visit 2).
Day 0 and Week 24.
Target Sample Size
Total Sample Size="282" Sample Size from India="282" Final Enrollment numbers achieved (Total)= "282" Final Enrollment numbers achieved (India)="282"
Phase of Trial
Phase 3
Date of First Enrollment (India)
24/03/2025
Date of Study Completion (India)
13/11/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="0" 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 A Multicenter, Randomized, Comparative, Active-Controlled, Open label, Phase 3 Study to Evaluate the Efficacy and Safety of Semaglutide Injection in Comparison with Reference Biologic in Obesity Management.
A total of 282 patients with obesity at geographically distributed centres in India will be enrolled in this clinical trial to evaluate the efficacy and safety of Semaglutide Injection compared to Reference Biologic Injection (Semaglutide). Patients with obesity having Body mass index (BMI) more than or equal to 30 kg/m2 or more than or equal to 27 kg/m2 with the presence of at least one of the weight-related comorbidities (treated or untreated) [i.e., hypertension, dyslipidaemia or type 2 diabetes mellitus (T2DM)] and history of at least one self-reported unsuccessful dietary effort to lose body weight will be considered for enrolment in this study along with reduced calorie diet and increased physical activity. The enrolled patients will be allocated to either of the 2 study groups according to the centralized computer-generated randomization plan in a 2:1 (test product : comparator product) ratio.
The patients with obesity as per pre-defined inclusion/exclusion criteria will be screened (visit 1) within 2 weeks prior to their enrolment. The eligible patients will then be enrolled and randomized to either of the 2 study groups as per their randomization number on baseline visit (visit 2, week 0, day 0). Subjects will be provided with patient diary (for all patients) and glucometer (for diabetic patients only) at randomization visit. After randomization, patients will then be followed up on an outpatient basis with scheduled visits at week 4 (visit 3), week 8 (visit 4), week 12 (visit 5), week 16 (visit 6), week 20 (visit 7) and week 24 (visit 8 – End of Treatment [EOT]). After 4 weeks of treatment, there will be a safety follow-up through telephonic visit at week 28 (visit 9 – End of Study [EOS]). This will be a parallel group study and all the enrolled patients will be instructed to take the study medications for a treatment period of 24 weeks.