CTRI/2025/07/090921 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On:
27/10/2025
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 Phase III clinical trial to determine the efficacy and safety of semaglutide injection in weight management.
Scientific Title of Study
A Multicenter, Randomized, Comparative, Active-Controlled, Open-Label, Phase III Study to evaluate the Efficacy and Safety of Semaglutide Injection In Comparison With Wegovy® (Semaglutide) Injection in Weight Management.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICS/NAT/2024-007 Version 2.0, Date 15 JAN 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Mr Kartik Sahni
Designation
Director
Affiliation
Insignia Clinical Services Pvt. Ltd.
Address
#512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower Netaji Subhash Place , Pitampura
North West DELHI 110034 India
Phone
09868679414
Fax
Email
kartik.sahni@insigniacs.com
Details of Contact Person Scientific Query
Name
Mr Kartik Sahni
Designation
Director
Affiliation
Insignia Clinical Services Pvt. Ltd.
Address
#512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower Netaji Subhash Place , Pitampura
DELHI 110034 India
Phone
09868679414
Fax
Email
kartik.sahni@insigniacs.com
Details of Contact Person Public Query
Name
Dr G Venkata Ramana
Designation
Principal Scientist- Drug Development and Clinical Research
Affiliation
Natco Pharma Limited
Address
Natco House Road No.2, Banjara Hills Hyderabad-, India
Hyderabad TELANGANA 500034 India
Phone
914023547532
Fax
Email
gvramana@natcopharma.co.in
Source of Monetary or Material Support
Natco Pharma Limited, Natco House Road No.2, Banjara Hills Hyderabad-500 034, India
Primary Sponsor
Name
Natco Pharma Limited
Address
Natco House Road No.2, Banjara Hills Hyderabad-500 034, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Natco Pharma Limited
Natco House Road No.2, Banjara Hills Hyderabad-500 034, India
Department of Clinical Research, 4th Floor, Clinical Reseach Room, 16-II/41A, A,Raghava Cine Complex Road- 524001, India Nellore ANDHRA PRADESH
9849050063
smurthysatyanarayana@gmail.com
Dr Aman Khanna
Aman Khanna and Research Center
Department of Medicine, First Floor 15, Shashwan Opposite ESI Hospital, Gotri 390021, India Vadodara GUJARAT
9904402122
amankhanna1974@gmail.com
Dr Anjali Rajan Pillay
CIMET’s Inamdar Multispeciality Hospital
Department of Research Research Room, Ground Floor, Admin Building, Fatima Nagar-411040, India Pune MAHARASHTRA
9923694453
anjalipillay91@gmail.com
Dr Rajesh Gosavi
Datta Meghe Medical College And Shalinitai Meghe Hospital and Research Centre
Department of Clinical Research, Ground Floor of Block G, Clinical research Room, Hingna Road, Wanadongri, - 440016, India Nagpur MAHARASHTRA
9890225111
gosavirv.smhrc@gmail.com
Dr MV Rama Mohan
DEC Healthcare Hospital
Department of Clinical Research, 5th Floor, Clinical Reseach Room, 16-2-219, Pogathota- 524001, India Nellore ANDHRA PRADESH
9490463301
rammohanmddm@gmail.com
Dr Govardhan Rao
Excel Hospital
Department of Research, 5th floor, Room no. 501, Excel Hospital, Plot No. 29, Old Alwal, Near IG, Statue, Banda Basti, Old Alwal, Alwal, Secunderabad -500010, India Hyderabad TELANGANA
9440664042
goroshidrmanjunath@gmail.com
Dr K Sunil Naik
Government Medical College & Government General Hospital (Old RIMSGGH)
Department of Clinical Research, Research Wing, Research Room, 2nd Floor Beside FM ward Govt General Hospital-532001 Srikakulam ANDHRA PRADESH
9440828299
drsunilnaikggh@gmail.com
Dr Vishal Kumar Gupta
GSVM Medical College, Kanpu
Department of Medicine - 208002, India Kanpur Nagar UTTAR PRADESH
8765172558
drvishalgupta2007@yahoo.com
Dr Parag Shah
Gujarat Endocrine Centre ( A unit of Gujarat Endocrin Pvt. Ltd.)
Department of Research, Research room, 5th floor, 518-526, Block – B, AWS-3, Opp. Manav Mandir, Nr. Helmet Circle, Memnagar – 380052, India Ahmadabad GUJARAT
9824042688
Paragendo@gmail.com
Dr Ashok Pardeshi
Hiramongi Navneet Hospital
Department of Medicine OPD No 09 Ground Floor,
Mulund West Mumbai Valaji Ladha Road - 400080 India Mumbai MAHARASHTRA
9850044954
ashoksidd1963@gmail.com
Dr Renuka Rayana
King George Hospital
Department of Clinical Research First Floor Maharanipeta, Visakhapatnam 530002 India Visakhapatnam ANDHRA PRADESH
9030526346
drrenukaresearch@gmail.com
Dr Vadgaonkar Atul Vijaykumar
Maxcure Hospital
Department of Medicine Room No 03, First Floor, Narayan Sonawane Marg, Old DSouza Colony, Jehan Circle, Gangapur Road- 422005, India Nashik MAHARASHTRA
Department of General Medicine, Room No 03, Ground Floor, No. 01
Railway New Colony- 530016 India
Visakhapatnam ANDHRA PRADESH
9440122790
drgopalraoa@gmail.com
Dr Panchal Dharmendra Tulsibhai
PHC Prajna Healthcare
Department of Endocrinology, OPD Consenting Room 03 Second Floor, 205-208 Second Floor, Agam Avenue, Near Adani CNG Pump, Sabarmati-380005 India Ahmadabad GUJARAT
9879204223
panchaldrd@gmail.com
Dr Giriraja K V
Rajalakshmi Hospital
Department of General Medicine, Room No 01, Ground Floor
21/1, Lakshmi Pura, Main Road, Opp. Lakshmipura Lake, Vidyaranyapura Post- 560097 India Bangalore KARNATAKA
9448039952
drgirirajakv@gmail.com
Dr Ashok Kumar
Santosh Medical College Hospital
Department of General Medicine, Room No. 101, 1st Floor, No 1 Ambedkar Road Nehru Nagar-201001, India Ghaziabad UTTAR PRADESH
9499192696
smchgzb@gmail.com
Dr Kurmi Prakash Harishchandra
Shivam Hospital
C-4, Satyanarayan Society Gor no Kuvo. Jasadanagar Char Rasta Maninagar, Ahmedabad-380008 Gujrat INDIA Ahmadabad GUJARAT
9825047692
drprakashkurmi@yahoo.co.in
Dr Laxmi Kant Goyal
SMS Medical College and Attached Hospital
Department of Clinical Research, Ground floor Room no. 39, J.L.N road-302004, India Jaipur RAJASTHAN
Reference drug will be administered once weekly on the same day each week subcutaneously at any time of day, with or without meals for 24 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1.Patients of either gender, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study.
2.Body mass index (BMI) more than or equal to 30 kg per m2 or more than or equal 27 kg per m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated) hypertension, dyslipidemia or type 2 diabetes mellitus (T2DM) at screening and randomization.
3.History of at least one self-reported unsuccessful dietary effort to lose body weight.
4.Willing to comply with the dietary and physical activity requirement during the study.
5.Women of childbearing potential must have a negative urine pregnancy test prior to study entry.
[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Postmenopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural(spontaneous) amenorrhea and be greater than 45 years of age]
6.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) and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence).
Addl. Inclusion Criteria applicable for Type 2 Diabetes Mellitus patients-
7.Diagnosed with T2D more than or equal to 180 days prior to the day of screening.
8.Subjects who are on a stable treatment with metformin, sulphonylureas (SU) or metformin + SU for at least 90 days before screening along with diet and exercise control.
9.HbA1c 7.0-10.0% (both inclusive) at screening.
ExclusionCriteria
Details
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 more than 5 kg within 90 days before screening irrespective of medical records.
5.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.
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 more than 1 year before screening,
•Lap banding, if the band has been removed more than 1 year before screening,
•Intragastric balloon, if the balloon has been removed more than 1 year before screening or,
•Duodenal-jejunal bypass sleeve, if the sleeve has been removed more than 1 year before screening,
7.Uncontrolled thyroid disease, defined as TSH more than 6.0 mIU per L or less than 0.4 mIU per L.
8.History of major depressive disorder within 2 years before screening.
9.History of OR presence of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder etc.).
10.A lifetime history of a suicidal attempt.
11.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 more than or equal to 10, and or a score of more than or equal to 2 on Suicide item of HAM-D; 17 items scale at Screening.
13.Use of any herbal, non-herbal medicine with unknown, unspecified content within 90 days before screening.
14.History or presence of pancreatitis.
15.Calcitonin more than or equal to 100 ng per 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 per min per 1.73m2 [Note- CrCl will be calculated using MDRD formula].
18.Patients with aspartate transaminase [AST] more than 2 x upper limit of normal [ULN] OR alanine transaminase [ALT] more than 2 x ULN OR alkaline phosphatase [ALP] more than 2 x ULN OR serum bilirubin more than 1.5 x ULN) at Screening.
19.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.History of myocardial infarction, stroke or hospitalisation for unstable angina or transient ischemic attack within the past 60 days prior to screening.
21.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.Known or suspected abuse of alcohol or recreational drugs.
24.Known or suspected hypersensitivity to trial product(s) or related products.
24.Participation in another clinical trial within 90 days before screening.
25.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.
26.Any disorder, which in the investigator’s opinion, might jeopardize the subject’s safety or compliance with the protocol.
Addl. Exclusion criteria for Non -Diabetic Patients:
27.HbA1c more than or equal to 6.5% as measured at screening.
28.Treatment with glucose-lowering agent(s) within 90 days before screening.
Addl. Exclusion criteria for Diabetic Patients:
29.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.
30.Present or past history of Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Percentage change in body weight
Baseline and Week 24
Secondary Outcome
Outcome
TimePoints
Percentage change in body weight
Baseline, Weeks 4, 8, 12, 16 and 20
Proportion of patients having body weight reduction more than or equal to 5 percent from baseline
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Proportion of patients having body weight reduction more than or equal to 10 percent from baseline
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Change in BMI
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Change in waist circumference from baseline
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Change in SF-36 total score from baseline
Baseline, Weeks 4, 8, 12, 16, 20 and 24
For Diabetic patients only: Change in glycosylated hemoglobin from baseline
Baseline, Weeks 12 and 24
For Diabetic patients only: Change in FBG from baseline
Baseline, Weeks 4, 8, 12, 16, 20, and 24
For Diabetic patients only: Change in PPBG from baseline
Baseline, Weeks 4, 8, 12, 16, 20, and 24
For Non-diabetic patients only: Change in FBG from baseline
Baseline, Week 24
For Non-diabetic patients only:Change in glycosylated hemoglobin from baseline
Baseline, Week 24
For Non-diabetic patients only: Change in PPBG from baseline
Baseline, Week 24
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"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Obesity and overweight are conditions that
increase the risk of chronic health outcomes, including hypertension,
dyslipidemia, type 2 diabetes, cardiovascular disease, and certain cancers.
Weight loss of 5-10 percent in patients through diet and exercise is generally
accepted as beneficial on cardiometabolic risk factors.
Standard-of-care for treatment is lifestyle
therapy, such as reduced calorie, nutritionally complete diets, increased
physical activity, and behavioural modification but the magnitude of weight
loss achieved can be limited and difficult to maintain. Patients with morbid
obesity can have good outcomes with bariatric surgery. However, surgical
therapies are limited by factors including adverse effects, cost, and insurance
coverage, and there remains an unmet medical need. Semaglutide injection has already
been approve by FDA for management of obesity. It has been found effective in
weight management in phase III trial. The weight-loss benefit of semaglutide outweighs the potential risks in the intended
population. The treatment effect on weight loss is clinically meaningful and
expected to improve health outcomes in patients with obesity and overweight.
Natco
Pharma Limited has developed a proposed biosimilar to semaglutide Injection, and intends to conduct a phase III clinical study in India.
It is comparable to the RMP in terms of its physicochemical characteristics,
structure, and mechanism of action. Taking into account the results of the
analytical similarity, pharmacological, and toxicological profiles of IMP, and
previous clinical and marketing experience of WEGOVY, the present
study has been planned to compare the efficacy and safety of IMP versus Reference
Biologic WEGOVY in Weight Management.