CTRI/2025/04/085455 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On:
22/04/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A study to assess effectiveness and safety of Semaglutide Injection compared to Wegovy(Semaglutide Injection) in patient with weight management .
Scientific Title of Study
A Phase 3 multicenter randomized parallel group study to compare the efficacy and safety of Alkem Semaglutide versus innovator Semaglutide (Wegovy Novo Nordisk) in patients with obesity
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ALK39-SEM2 Version 1.1, Dated 06/Feb/2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Akhilesh Sharma
Designation
President & CMO
Affiliation
Alkem Laboratories Limited
Address
Alkem Laboratories Limited Alkem House Devashish Adjacent to Matulya center Senapati Bapat Marg Lower Parel Mumbai MAHARASHTRA 400013 India Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai (Suburban) MAHARASHTRA 400013 India
Phone
9701346369
Fax
Email
akhilesh.sharma@alkem.com
Details of Contact Person Scientific Query
Name
Dr Vinayaka Shahavi
Designation
General Manager-Clinical Research
Affiliation
Alkem Laboratories Limited
Address
Alkem Laboratories Limited Alkem House Devashish Adjacent to Matulya center Senapati Bapat Marg Lower Parel Mumbai Mumbai MAHARASHTRA 400013 India Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai (Suburban) MAHARASHTRA 400013 India
Phone
9833219090
Fax
Email
vinayaka.shahavi@alkem.com
Details of Contact Person Public Query
Name
Dr Vinayaka Shahavi
Designation
General Manager-Clinical Research
Affiliation
Alkem Laboratories Limited
Address
Alkem Laboratories Limited Alkem House Devashish Adjacent to Matulya center Senapati Bapat Marg Lower Parel Mumbai Mumbai MAHARASHTRA 400013 India Mumbai (Suburban) MAHARASHTRA 400013 India
All India Institute Of Medical Sciences, Chhattisgarh
All India Institute Of Medical Sciences,
Gate No 1, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099
Raipur CHHATTISGARH
9547108310
amritava_ghosh@yahoo.co.in
Dr Kishore Kumar Behera
All India Institute of Medical Sciences, Bhubaneswar, Odisha
Department of endocrinology, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha 751019 Khordha ORISSA
20/1, Dr. Khare Marg, Dhantoli, Nagpur-440012 Nagpur MAHARASHTRA
9665013901
drshembalkar@gmail.com
Dr Gandhi Parise
Government Siddhartha Medical College
Department of clinical research, 1st floor, C Block, Government Medical college and Hospital, Ring Road, Gunadala, Vijayawada-520008, AP-India Krishna ANDHRA PRADESH
9492732771
parisegandhi34@gmail.com
Dr Mayura Chaudhari
Ishwar Institute of Health Care, Aurangabad
Ishwar Heights, 1st floor, Plot No. 7, gut no. 6/1 Beside punjabi Bhawan, Padegaon Aurangabad- 431002. Aurangabad MAHARASHTRA
9764851103
ishwarhealthcare@gmail.com
Dr Deepak Khandelwal
Jaipur Golden Hospital, Delhi
Room Number: 48, Ground Floor, Jaipur Golden Hospital, Institutional Area, Sector-III, Rohini, Delhi- 110085
New Delhi DELHI
9968878561
khandelwalaiims@gmail.com
Dr Aruna Mangipudi
King George Hospital, Visakahapatnam.
Department of Endocrinology, King George Hospital, Maharanipeta, Visakahapatnam, Andhra Pradesh- 530002. Visakhapatnam ANDHRA PRADESH
9440105711
drarunamangipudiresearch@gmail.com
Dr Amol Dange
Lifepoint Multispeciality Hospital, Pune
145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune- 411057 Pune MAHARASHTRA
9823912040
amoldange298@gmail.com
Dr Niteen D Karnik
Lokmanya Tilak Munciple Medical college & General hospital, SION. Mumbai
Lokmanya Tilak Munciple Medical college & General hospital, Dr. Babasaheb Ambedkar Road, Sion (West), Mumbai - 400022
Mumbai MAHARASHTRA
9821483404
drndkarnik@hotmail.com
Dr Raja Bhattacharya
Medical College and Hospital, Kolkata
MCH Building, 4th Floor, 88 college street, Kolkata- 700073 Kolkata WEST BENGAL
8100273048
rbrbhattacharya@gmail.com
Dr Vivek Samadhan Shejole
Medipoint Hospital, Pvt.Ltd,Pune
241/1, New D.P.Road, Aundh Pune Maharashtra - 411007 India Pune MAHARASHTRA
9890847636
drvivek.medipoint@gmail.com
Dr Ashu Rastogi
Postgraduate Institute of Medical Education and Research ,Chandigarh
Department of Endocrinology and Metabolism, PGIMER Chandigarh, Sector-12 CHD 160012 Chandigarh CHANDIGARH
9781001046
ashuendo@gmail.com
Dr Jasminder Singh
Pt. B.D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana
Department of Medicine, Pt. B.D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana- 124001 Rohtak HARYANA
9813140750
jasminder.singh20@gmail.com
Dr Sanket Sorte
Sanjeevani Criticare And Research Centre Pvt Ltd .
Reference product will be administered once weekly at any time of day, with or without meals for 24 weeks.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
The patients will be included in the study based on the following criteria:
1.Willing to provide voluntary written informed consent and able to comply with the protocol requirements.
2. Male or female, age more than equal to 18 years at the time of signing informed consent
3. Body mass index (BMI) more than equal to 30 kg/m2 or more than equal to 27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease.
4. History of at least one self-reported unsuccessful dietary effort to lose bodyweight
5. Sr. Calcitonin level of less than 50 ng/L at screening
ExclusionCriteria
Details
The patients will be excluded from the study based on the following criteria:
Glycaemia-related:
1. HbA1c more than equal to 48 mmol/mol (6.5%) at screening
2. History of type 1 or type 2 diabetes mellitus
3. Treatment with glucose-lowering agent(s) within 90 days before screening
4. Treatment with a GLP-1 receptor agonist within 180 days before screening.
Obesity-related:
5. A self-reported gain in body weight by more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
6. Treatment with any medication for the indication of obesity within the past 90 days before screening
7. Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed more than 1 year before screening, (2) lap banding, if the band has been removed more than 1 year before screening, (3) intragastric balloon, if the balloon has been removed more than 1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed more than 1 year before screening
8. Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) more than 6.0mIU/L or less than 0.4 mIU/L at screening.
Mental health:
9. History of major depressive disorder within 2 years before screening
10. Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
11. Any lifetime history of a suicidal attempt or suicidal behavior within 30 days before screening
12. Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days before screening.
General safety:
13. Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening
14. Presence of acute pancreatitis within the past 180 days prior to the day of screening
15. History or presence of chronic pancreatitis
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 45 ml/min/1.73 m2
18. History of malignant neoplasms within the past 5 years prior to screening.
19. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the past 60 days prior to screening
20. Subject presently classified as being in New York Heart Association (NYHA) Class IV
21. Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator
22. Known or suspected abuse of alcohol or recreational drugs
23. 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 effective contraceptive method during study period
26. Female Patient of child bearing potential using oral contraceptives.
27. Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion, might jeopardize the subject’s safety or compliance with the protocol.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Investigator Blinded
Primary Outcome
Outcome
TimePoints
Percentage change in body weight from baseline to Week 24
baseline to Week 24
Secondary Outcome
Outcome
TimePoints
Proportion of patient achieving more than 10% and more than 15% loss in body weight at 24 weeks
Change BMI from baseline to Week 24
Change in waist circumference from baseline to week 24
Change in HbA1c from baseline to week 24
Proportion of patients with anti-drug antibodies (ADA) and neutralizing antibody from baseline to week 24
baseline to Week 24
Target Sample Size
Total Sample Size="249" Sample Size from India="249" 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)
03/05/2025
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="1" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Closed to Recruitment of Participants
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
A Phase 3, multicenter, randomized, parallel-group study to compare the efficacy and safety of Alkem Semaglutide versus innovator Semaglutide (Wegovy, Novo Nordisk) in patients with obesity.
A total 249 patients who meet the eligibility criteria will
be randomized in the ration of 2:1 to receive either test product or reference
product for 24 weeks.
The total study duration will be approximately 13 months
considering screening period of 2 weeks, about 6 months of recruitment period
and 24 weeks of study period.
Screening Period: Up to 2 weeks
Treatment Period: It will last for 24 weeks
End of study (EOS) assessment: EOS assessment will be
performed at Week 24.
The primary and secondary endpoint of this trial are as
follow:
Primary efficacy endpoint:
Percentage change in body weight from baseline to Week 24.
Secondary efficacy endpoint(s):
Proportion of patient
achieving more than 10% and more than 15% loss in body weight at 24 weeks.
Change BMI from
baseline to Week 24.
Change in waist
circumference from baseline to week 24.
Change in HbA1c from
baseline to week 24.
Safety endpoint(s):
Treatment emergent
serious and non-serious adverse events (AEs) during the study.
Alteration in
clinical laboratory parameters during the study.
Immunogenicity End Point:
Proportion of patients with anti-drug antibodies (ADA) and
neutralizing antibody from baseline to week 24.