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CTRI Number  CTRI/2021/10/037678 [Registered on: 29/10/2021] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Research study on whether a combination of 2 medicines (NNC0194-0499 and semaglutide) works in people with non-alcoholic steatohepatitis (NASH) 
Scientific Title of Study   Efficacy and safety investigation of NNC0194-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
NN9500-4656_V 1.0_06 Jan 2021  Protocol Number 
NN9500-4656_v 3.0_14 Oct 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Vijay Parthasarathy 
Designation  Director, CDC India 
Affiliation  Novo Nordisk India Pvt. Ltd. 
Address  Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045.
Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045
Bangalore
KARNATAKA
560045
India 
Phone  8040303200  
Fax  08041123518  
Email  VJYP@novonordisk.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Vijay Parthasarathy 
Designation  Director, CDC India 
Affiliation  Novo Nordisk India Pvt. Ltd. 
Address  Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore
Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore
Bangalore
KARNATAKA
560045.
India 
Phone  8040303200  
Fax  08041123518  
Email  VJYP@novonordisk.com  
 
Source of Monetary or Material Support
Modification(s)  
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 
 
Primary Sponsor
Modification(s)  
Name  Novo Nordisk 
Address  Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045. India Whitefield 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Singapore
India
Malaysia
Australia
Belgium
Bulgaria
Cameroon
Denmark
France
Germany
Greece
Italy
Japan
Netherlands
Poland
Republic of Korea
Russian Federation
Spain
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 18  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shalimar  All India Institute of medical sciences  All India Institute of medical sciences, Room No.124, First Floor, Human Nutrition unit, Old OT Block, Ansari Nagar, 110029, New Delhi.
New Delhi
DELHI 		 919968405815

drshalimar@yahoo.com 
Dr Parshottam Koradia  BAPS Pramukh Swami Hospital  BAPS Hospital Institutional Ethics Committee BAPS Pramukh Swami Hospital BAPS Pramukh Swami Hospital Adajan Cross Road, Adajan Surat Surat Gujarat - 395009 India
Surat
GUJARAT 		 919825312027

purushottam_koradia@yahoo.co.in 
Dr Vandana Midha  Dayanand Medical College and Hospital  Dayanand Medical College and Hospital, Ludhiana, 141001, Punjab
Ludhiana
PUNJAB 		 919815528289

vandana_midha2@yahoo.co.in 
Dr Gaurav Kumar Gupta  Department of Gastroenterology, Sawai Man Singh Hospital  Department of Gastroenterology, Sawai Man Singh Hospital, Jawahar Lal Nehru Marg, Jaipur-302004, Rajasthan.
Jaipur
RAJASTHAN 		 919887870552

drgauravsms@gmail.com 
Dr Paturi Vishnupriya Rao  Diabetes Research Center  Diabetes Research Center First Floor 6-3-349/178, Hindi Nagar Colony, Behind Panjagutta Saibaba Temple, Hyderabad, Telangana - 500082 India
Hyderabad
TELANGANA 		 914026661331

raopaturi@gmail.com 
Dr Kiran Pal Singh  Fortis Hospital  Fortis INN, Fortis Hospital, Sector-62, Phase-8, Mohali-160062
Chandigarh
CHANDIGARH 		 9815311711

drkp1292@gmail.com 
Dr Alisha Chaubal  Gleneagles hospital-super speciality and transplant centre  Gleneagles hospital-super speciality and transplant centre,35, Dr. E. Borges road, Hospital avenue, Opp. Dr shirodkar high school, Parel, 400012, Maharashtra.
Mumbai
MAHARASHTRA 		 7045323788

alishachaubal@gmail.com 
Dr Shiv Kumar Sarin  Institute of liver and biliary sciences  Institute of liver and biliary sciences, D-1, Vasant Kunj, 110070, New Delhi
New Delhi
DELHI 		 919540947000

sksarin@ilbs.in 
Dr B V Tantry  Kasturba Medical College Hospital   Kasturba Medical College Hospital Dr.B.R.Ambedker Circle, Mangalore-575001, Karnataka
Bangalore
KARNATAKA 		 919845789100

tantrybv@gmail.com 
Dr Santosh Hajare  KLES Dr Prabhakar Kore Hospital & MRC  KLES Dr Prabhakar Kore Hospital & MRC, Nehru Nagar, Belagavi-10
Belgaum
KARNATAKA 		 9448111913

drsantoshhajare@gmail.com 
Dr Narendra Choudhary  Medanta The Medicity Hospital  Medanta The Medicity Hospital, Sec-38, Gurgaon, Haryana - 122 001, India.
Gurgaon
HARYANA 		 8130188600

Narendra.Choudhary@Medanta.org 
Dr Srikant Mukewar  Midas Multispeciality Hospital pvt.ltd.  Midas Hospital, 392, Behind Empress Palace, Opp Singh Saab Dhaba, Wardha Road, Parsodi, Nagpur-441108, Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA 		 917720033280

shrikant_mukewar@yahoo.com 
Dr Rakesh Kumar Sahay  Osmania Medical College  Koti, Hyderabad-500095, Telangana, India
Bangalore
KARNATAKA 		 9849597507

sahayrk@gmail.com 
Dr Ajay Duseja   Post Graduate Institute of Medical Education and Research Nehru hospital  Post Graduate Institute of Medical Education and Research Nehru hospital, 2nd floor, d Block, faculty offices, room no.-5, sector- 12, pgimer, 160012, Chandigarh.
Chandigarh
CHANDIGARH 		 919417007416

ajayduseja@yahoo.co.in 
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
Jaipur
RAJASTHAN 		 919829050622

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, 400012, Mumbai.
Mumbai
MAHARASHTRA 		 919869256376

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 		 919879863510

rmgastro@yahoo.com 
Dr Dharmesh Kapoor  Yashoda Hospitals  Yashoda Hospitals, Secunderabad, Hyderabad-500003, Telangana
Hyderabad
TELANGANA 		 919849439407

dharmesh_kapoor@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 20  
Name of Committee  Approval Status 
Drug Trial Ethics Committee, Dayanand Medical College & Hospital, Ludhiana-141001, Punjab, India  Approved 
Ethics Committee, Osmania Medical College, Koti, Hyderabad-500095, Telangana India  Approved 
IEC Fortis Hospital Mohali Fortis Hospital Mohali Sector - 62 Phase VIII Mohali SAS Nagar Punjab - 160062 India   Approved 
Institute Ethics Committee All India Institute of Medical Sciences Old OT Block, Room no. 102, AIIMS Hospital Ansari Nagar, New Delhi-29 - 110029, India  Approved 
Institutional ethics comittee of KLE Academy of higher education and research  Approved 
Institutional Ethics Committee Diabetes Research Center First Floor 6-3-349/17B, Hindi Nagar Colony Behind Panjagutta Saibaba Temple Hyderabad Hyderabad Telangana - 500082 India  Approved 
Institutional Ethics Committee Institute of Liver and Biliary Sciences D-1 Vasant Kunj New Delhi - 110070, India  Approved 
INSTITUTIONAL ETHICS COMMITTEE MAMC MAULANA AZAD MEDICAL COLLEGE RED FLOOR ROOM NO 306B BAHADUR SHAH ZAFER MARG DELHI New Delhi Delhi - 110002 India  Submittted/Under Review 
Institutional Ethics Committee Midas Multispeciality Hospital pvt ltd , Midas Hospital, 392, Behind Empress Palace, Opp Singh Saab Dhaba, Wardha Road, Parsodi, Nagpur-441108,Nagpur MAHARASHTRA 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 - 160012 India  Submittted/Under Review 
Institutional Ethics Committee, AIIMS Jodhpur All India Institute of Medical Sciences, Jodhpur, All India Institute of Medical Sciences, Basni Phase-II, Jodhpur, Jodhpur, Jodhpur, Rajasthan- 342005  Submittted/Under Review 
Institutional Ethics Committee, BAPS Pramukh Swami HospitalS  Approved 
Institutional Ethics Committee, Gleneagles 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-l Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai-400 012, Maharashtra, India  Submittted/Under Review 
MAHE Ethics Committee Manipal, Manipal Academy of Higher Education(MAHE) Manipal, Udupi-576104, Karnataka, India  Approved 
Max Healthcare Ethics Committee Ground floor, Office of Ethics Committee, West block, Near MS Office Max Super Specialist Hospital, Saket (A unit of Max Healthcare Institute Limited) 1, Press enclave Road, Saket, New Delhi, 110017 India  Submittted/Under Review 
Medanta Institutional Ethics Committee,Medanta The Medicity , Sector 38, Gurgaon, Haryana - 12001  Approved 
SR Kalla Memorial Ethical Committee For Human Research, S.R. Kalla Memorial Gastro General Hospital, 78-79 Dhuleshwar Garden, Behind HSBC Bank Sardar Patel Marg C-Scheme Jaipur-302001 Rajasthan, 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-500003, Telangana, 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 
Intervention  NNC0174-0833  Dose: 2.4 mg Route of Administration: Subcutaneous Duration of Therapy: 52 weeks 
Intervention  NNC0174-0833 Placebo  Dose: 2.4 mg Route of Administration: Subcutaneous Duration of Therapy: 52 weeks 
Intervention  NNC0194-0499  Dose: 7.5mg, 15mg, 30mg Route of Administration: Subcutaneous Duration of Therapy: 52 weeks 
Intervention  Placebo C  Dose: 7.5mg, 15mg, 30mg Route of Administration: Subcutaneous Duration of Therapy: 52 weeks 
Comparator Agent  Semaglutide   Dose: 2.4 mg Route of Administration: Subcutaneous Duration of Therapy: 52 weeks 
Comparator Agent  Semaglutide Placebo  Dose: 2.4 mg Route of Administration: Subcutaneous Duration of Therapy: 52 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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.
2. Aged ≥ 18 years at the time of signing informed consent. Japan, Republic of Korea and
Singapore: Please 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 V1.
4. Histological evidence of fibrosis stage 2, 3 or 4 according to the NASH CRN classification
based on a central pathologist evaluation of the baseline liver biopsy.
5. Histological NAFLD activity score (NAS) ≥ 4 for subjects with F2/F3 or ≥ 3 for subjects with
F4 based on a central pathologist evaluation of the baseline liver biopsy. All subjects must have
a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning. 
 
ExclusionCriteria 
Details  • Documented causes of chronic liver disease other than NAFLD.
• Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known
presence of HCV RNA or HBsAg within 2 years of screening (V2A).
• Presence or history of ascites more than grade 1, variceal bleeding, hepatic encephalopathy,
spontaneous bacterial peritonitis or liver transplantation at V2A.
• Presence or history of gastro-oesophageal varices ≥ grade 2 at V2A. For subjects with F4, an
oesophagogastroduodenoscopy performed no more than 52 weeks prior to V2A must be
available at V2A.
• Known or suspected excessive consumption of alcohol (> 20 g/day for women or > 30 g/day for
men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test
(AUDIT questionnaire)).
• Treatment with vitamin E (at doses ≥ 800 IU/day) or pioglitazone or medications approved for
the 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 V2A. In addition, for subjects with a historical liver biopsy
taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the
investigator from time of biopsy until V2A.
• Treatment with GLP-1 RAs within 90 days prior to V2A. Subjects with a historical liver biopsy
taken more than 90 days prior to V2A are excluded if they receive treatment with GLP-1 RAs
from time of biopsy until V2A.
• 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 V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days
prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of
biopsy until V2A. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in liver fibrosis and no worsening of
NASH 		 Week 0 to Week 52 
 
Secondary Outcome  
Outcome  TimePoints 
Resolution of steatohepatitis and no worsening of liver
fibrosis 		 Week 0 to Week 52 
 
Target Sample Size   Total Sample Size="672"
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" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/11/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/09/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Currently, no drugs are globally approved for the treatment of non-alcoholic steatohepatitis (NASH). First-line of treatment is lifestyle intervention to achieve weight loss and treatment of comorbidities (e.g. hyperlipidaemia, hypertension and diabetes). There is a substantial unmet medical need for effective treatments in patients with NASH. Combination treatment with modalities directed against multiple targets may result in better efficacy in subjects with NASH. This phase 2 trial will assess the safety and efficacy of three doses of NNC0194-0499 in combination with semaglutide versus placebo in the treatment of NASH. The trial will also include treatment arms for NNC0194-0499 alone, semaglutide alone and NNC0174-0833 in combination with semaglutide.
 
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