Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045. India
Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli,
Bangalore - 560045. India
Bangalore KARNATAKA 560045 India
Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli,
Bangalore - 560045. India
Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli,
Bangalore - 560045. India
Bangalore KARNATAKA 560045 India
Novo Nordisk India Private Limited,
Nxt Tower - 2, Floor 1 & 2
Embassy Manyata Business Park,
Nagavara Village, Kasaba Hobli,
Bangalore - 560045. India
Tel No.: 080-40303200
Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 & 2
Embassy Manyata Business Park,
Nagavara Village, Kasaba Hobli,
Bangalore - 560045. India
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
Argentina Australia Austria Belgium Brazil Bulgaria Canada China Croatia Czech Republic Denmark France Germany Greece India Ireland Israel Italy Japan Malaysia Mexico Netherlands Norway Poland Romania Russian Federation Serbia Slovakia South Africa Spain Switzerland Taiwan Turkey United Kingdom United States of America
Gleneagles Hospital, Super - Specialty and transplant centre Mumbai
Gleneagles Hospital-super specialty and transplant centre,35, Dr. E. Borges road, Hospital avenue, Opp. Dr shirodkar high school, Parel,400012,Maharashtra, Indi Mumbai MAHARASHTRA
9820144338
alishachaubal@gmail.com
Dr Shiv Kumar Sarin
Institute Of Liver And Biliary Sciences
Institute Of Liver And Biliary Sciences , D-1, Vasant Kunj, New Delhi 110070,India New Delhi DELHI
9540947000
sksarin@ilbs.in
Dr B V Tantry
Kasturba Medical College Hospital
Kasturba Medical College Hospital Dr.B.R.Ambedker Circle, Mangalore-575001, Karnataka Dakshina Kannada KARNATAKA
09845789100
tantrybv@gmail.com
Dr Paturi Vishnupriya Rao
Kumudini Devi Diabetes Research Center
Diabetes Research Center First Floor 6-3-349/178,Hindi Nagar Colony, Behind Panjagutta Saibaba Temple,
Hyderabad, Telangana - 500082 India -500072, Telangana, India. Hyderabad TELANGANA
Sec-38, Gurgaon, Haryana - 122 001, India Gurgaon HARYANA
8130188600
Narendra.Choudhary@Medanta.org
Dr Shrikant Mukewar
Midas multispeciality hospital pvt.ltd
Midas Hospital, 392, Behind Empress Palace, Opp Singh Saab Dhaba, Wardha Road, Parsodi, Nagpur-441108. Nagpur MAHARASHTRA
7720033280
shrikant_mukewar@yahoo.com
Dr Rakesh Kumar Sahay
Osmania General Hospital
Osmania General Hospital,
Hyderabad,
Telangana - 500012
Hyderabad TELANGANA
9849597507
sahayrk@gmail.com
Dr Ajay Duseja
Post Graduate Institute of Medical Education and Research
Post Graduate Institute of Medical Education and Research
Nehru hospital, 2nd floor, d
Block, Faculty offices,room no.-5, sector- 12 , PGIMER,chandigarh,160012 Chandigarh CHANDIGARH
9417007416
ajayduseja@yahoo.co.in
Dr Mukesh Jain
S.M.S Hospital
S.M.S Hospital,JLN marg, jaipur,302004, Rajasthan, India Jaipur RAJASTHAN
9414323607
drmukeshjaingastro@gmail.com
Dr Mukesh Kalla
S.R. Kalla memorial gastro and general hospital
S.R. Kalla memorial gastro and general hospital
78-79 dhuleshwar garden behind hsbc bank
Sp marg c-scheme jaipur-302001 rajasthan india Jaipur RAJASTHAN
9829050622
drmkalla@rediffmail.com
Dr Akash Shukla
Seth G.S.Medical College and K.E.M Hospital
Seth G.S.Medical College and K.E.M Hospital, Department of Gastroenterology,Ward 32A,9th floor,M.S.Building,, Parel,Mumbai 400 012 Mumbai MAHARASHTRA
9869256376
drakashshukla@yahoo.com
Dr Rajiv Mehta
Surat institute of Digestive Sciences
SIDS Hospital & Research centre
A unit of SIDS health care private limited, Near shell petrol pump
Ring road-sosyo circle lane, Surat-395002, Gujarat, India. Surat GUJARAT
9537799664
rmgastro@yahoo.com
Dr Dharmesh Kapoor
Yashoda Hospital
Secunderabad
Hyderabad-500003,
Telangana, India.
Hyderabad TELANGANA
BAPS Hospital Institutional Ethics Committee BAPS Pramukh Swami Hospital Adajan Cross Road, Adajan Surat Surat Gujarat - 395009 India
Approved
Drug Trial Ethics Committee Dayanand Medical College and Hospital, Civil Lines, Ludhiana, 141001, Punjab, India
Approved
Ethics Committee S.M.S. Medical College and Attached Hospitals J.L.N. Marg Jaipur Jaipur Jaipur Rajasthan - 302004 India
Approved
IEC Fortis Hospital Mohali Fortis Hospital Mohali Sector - 62 Phase VIII Mohali SAS Nagar Punjab - 160062 India
Approved
Inst.Ethics committee for MV Hospital MV Hospital And Research Centre 314/30, Mirza Mandi Chowk Lucknow- Uttar Pradesh Lucknow Lucknow Uttar Pradesh - 226003 India
Approved
Institute Ethics Committee All india institute of medical sciences Old OT block, room no. 102, aiims hospital ansari nagar, new delhi-29 new delhi south delhi delhi - 110029 india
Approved
Institutional Ethics Committee Global Hospital,Room No.222, 2nd Floor, Dr. E. Borges Road,Hospital Avenue, Opp. Dr Shirodkar High School, Parel, Mumbai, Maharashtra – 400012, India
Approved
Institutional ethics committee Midas multispeciality hospital pvt ltd Midas multispeciality hospital, midas height 07 central Bazar road, ramdaspeth nagpur nagpur Maharashtra - 440010 india
Approved
Institutional ethics committee Post graduate institute of medical education and research,room no. 6006, iec office, 6th floor p n chuttani Block chandigarh chandigarh chandigarh - 160012 India
Approved
Institutional Ethics Committee, Institute of Liver and Biliary Sciences D-1 Vasant Kunj, New Delhi -110070, India
Approved
Institutional Ethics Committee, Ramdevrao Hospital (A unit of Sivananda Rehabilitation Home), Kukatpally, Hyderabad-500072. Telangana. India.
Approved
Institutional Ethics Committee-l Seth GS Medical College and KEM Hospital, Mumbai. Acharya Donde Marg, Parel, . Mumbai 400 012. India Mumbai Mumbai City Maharashtra - 400012 India
Submittted/Under Review
Institutional Ethics Committee Osmania Medical College, Koti, Hyderabad – 500 095, Telangana, India
Approved
MAHE Ethics Committee Manipal, Manipal Academy of Higher Education(MAHE) Manipal, Udupi-576104, Karnataka, India
S.R.Kalla Memorial Ethical Committee For Human Research, S.R.KallaMemorial Gastro General Hospital 78-79 Dhuleshwar Garden Behind HSBC Bank Sardar Patel Marg C-Scheme Jaipur Jaipur Rajasthan - 302001 India
Approved
Surat Institute of Digestive Science Ethics Committee SIDS Hospital & Research centre A unit of SIDS health care private limited, Near shell petrol pump Off Ring Road, Near Shell petrol pump, Ring road-sosyo circle lane, Surat-395002, Gujarat, India.
Approved
Yashoda Academy of Medical Education and Research Yashoda hosptials Behind Hari Hara kala Bhawan Alexander Road Secunderabad Hyderabad Telangana - 500003 India
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: K740||Hepatic fibrosis,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Semaglutide Ia & Ib Placebo
0.5mg , 1mg, 2mg ,2.27mg & 3.2mg
Once Weekly (OW)
Subcutaneous till 5 years
Intervention
Semaglutide D
0.5mg , 1mg, 2mg ,2.27mg & 3.2mg
Once Weekly (OW)
Subcutaneous till 5 years
Subjects are eligible to be included in the trial only if all of the following criteria apply:
1. Informed consent obtained before any trial-related activities. Trial-related activities are any
procedures that are carried out as part of the trial, including activities to determine suitability for
the trial except for protocol-defined pre-screening activities, which require a separate informed
consent. Ireland: See local requirements in Appendix 9 (Section 10.9).
2. Age above or equal to 18 years at the time of signing informed consent. Japan, South Korea
and Taiwan: See local requirements in Appendix 9 (Section 10.9).
3. Histological evidence of NASH based on a central pathologist evaluation of the baseline liver
biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to
screening visit (V1).
4. Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN classification
based on a central pathologist evaluation of the baseline liver biopsy.
5. A histological NAS ≥ 4 with a score of 1 or more in steatosis, lobular inflammation and
hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy.
China: See local requirements in Appendix 9 (Section 10.9).
ExclusionCriteria
Details
Positive HBsAg, positive anti-HIV, positive HCV-RNA at screening or any known presence of
HCV RNA or HBsAg within 2 years of screening (V2A).
Documented causes of chronic liver disease other than Non-Alcoholic Fatty Liver Disease
NAFLD.
Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial
peritonitis or liver transplantation at randomisation.
Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test(AUDIT questionnaire).
Treatment with vitamin E (at doses greater or equal to 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical
liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In
addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening.
Treatment with glucose lowering agent(s) (other than GLP-1 RAs), lipid lowering medication or
weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Resolution of steatohepatitis and no worsening of liver fibrosisa.
Improvement in liver
fibrosis and no worsening
of steatohepatitis.
Time to first liver-related clinical event
Week 0 to Week 72
Secondary Outcome
Outcome
TimePoints
Progression of liver fibrosis
Change in body weight
Change in SF-36 Bodily Pain
Week 0 to Week 72
Week 0 to Week 240
Target Sample Size
Total Sample Size="1200" Sample Size from India="60" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
This is a randomised, multicentre, double-blinded, parallel-group, trial comparing semaglutide s.c. 2.4 mg once weekly versus placebo s.c. once weekly in subjects with NASH and F2 or F3 (recruitment cap of approximately 20% for subjects with fibrosis stage 2). Approximately 6150 subjects will be screened to achieve 1200 subjects randomly assigned to trial product. Subjects will be randomised 2:1 to receive either treatment with semaglutide s.c. or placebo. Randomisation will be stratified based on the presence of T2D at screening (defined as a medical history of T2D and/or HbA1c greater or equal to 48 mmol/mol (greater or equal to 6.5 %)), fibrosis stage and region. For both semaglutide s.c. and placebo there will be a period of dose escalation before reaching the target dose. The total trial duration for each subject is approximately 257 weeks (~4 years and 11 months). This includes a screening period of approximately 14 weeks followed by randomisation and a 240-week treatment period. The follow-up period is 7 weeks.