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CTRI Number  CTRI/2018/07/014765 [Registered on: 09/07/2018] Trial Registered Prospectively
Last Modified On: 11/02/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   STEP-1: Research study investigating how well semaglutide works in people suffering from overweight or obesity 
Scientific Title of Study   Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NN9536-4373, version 2.0 and dated 21 Dec 2017  Protocol Number 
U1111-1200-8053  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Anil N Shinde 
Designation  Director – Clinical, Medical, Regulatory Affairs & Quality (CMRQ) 
Affiliation  NOVO NORDISK INDIA PVT LTD. 
Address  Novo Nordisk India Private Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore - 560 066

Bangalore
KARNATAKA
560066
India 
Phone  919148526835  
Fax  918041123517  
Email  ansd@novonordisk.com  
 
Details of Contact Person
Public Query  
Name  Dr Anil N Shinde 
Designation  Director – Clinical, Medical, Regulatory Affairs & Quality (CMRQ) 
Affiliation  NOVO NORDISK INDIA PVT LTD. 
Address  Novo Nordisk India Private Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore - 560 066


KARNATAKA
560066
India 
Phone  919148526835  
Fax  918041123517  
Email  ansd@novonordisk.com  
 
Source of Monetary or Material Support  
Novo Nordisk India Private Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield Bangalore Karnataka-560 066 
 
Primary Sponsor  
Name  Novo Nordisk AS 
Address  Novo Allé, 2880 Bagsvaerd Denmark 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Novo Nordisk India Private Ltd  Plot No.32, 47 - 50, EPIP Area, Whitefield Bangalore Karnataka-560 066 
 
Countries of Recruitment     Argentina
Belgium
Bulgaria
Canada
Denmark
Finland
France
Germany
India
Japan
Mexico
Poland
Russian Federation
Taiwan
United Kingdom
United States of America  
Sites of Study  
No of Sites = 17  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yashdeep gupta  All India Institute of Medical Sciences  Department of Endocrinology,Ansari Nagar,New Delhi-110029
New Delhi
DELHI 		 9999598468

yash_deep_gupta@yahoo.co.in 
Dr Symasis Bandyopandhyay  Apollo Gleneagles Hospitals  Department of General Medicine,8-Canal Circular Road, Kolkata-700 054, West Bengal.
Kolkata
WEST BENGAL 		 9836576602

sambando@yahoo.co.uk 
Dr R Mehrothra  Apollo Hospital  Department of Endocrinology,Apollo Research & Innovations,1st Floor, AIMSR, Apollo Health City, Jubilee Hills, Hyderabad--500096 Telangana.
Hyderabad
ANDHRA PRADESH 		 9490267373

dr.ravi.apollo@gmail.com 
Dr A G Unnikrishnan  Chellaram Diabetes Hospital  Department of Endocrinology,Lalani Quantum,Pune Bangalore Highway, Bavdhan Buduk,Pune-411021, Maharashtra
Pune
MAHARASHTRA 		 9850811450

uag@cdi.org.in 
Dr Dinesh Jain  Dayanand Medical College and Hospital  Department of Medicine, R and D Centre, Tagore Nagar, Civil Lines, Near Rose Garden, Ludhiana- 141001, Punjab.
Ludhiana
PUNJAB 		 6280211789

drjaindinesh@yahoo.co.in 
Dr Vaishali Deshmukh  Deenanath Mangeshkar Hospital & Research Centre  Department of Endocrinology,Superspeciality building Ground Floor, Erandawane ,Pune 411004, Maharashtra.
Pune
MAHARASHTRA 		 9986697282

researchendo@gmail.com 
Dr K Srikanth  Endolife Speciality Hospital Pvt Ltd  Department of Endocrinology,D-NO:12-12-94, Old Club Road Kothapet, Guntur-522001 Andhra Pradesh
Guntur
ANDHRA PRADESH 		 9849945577

srikanthendo@gmail.com 
Dr Thulaseedharan  Government Medical College  Department of General Medicine, Kozhikode,Medical college Road, Kozhikode-673008, Kearla
Kozhikode
KERALA 		 9847955875

dr.thulaseedharan@gmail.com 
Dr A Somalwar  Government Medical College and Hospital  Department of General Medicine, Research Room, Opposite Ward No.2 , Medical College Square, Nagpur-440003, Maharashtra
Nagpur
MAHARASHTRA 		 8806625533

amsomalwar@gmail.com 
Dr Jabbar  Indian Institute of Diabetes  Department of Endocrinology, Pulayanarkotta, Thiruvananthapuram-695031,Kerala.
Thiruvananthapuram
KERALA 		 9447783817

drjabbar10@gmail.com 
Dr Arpandev Bhattacharya  Manipal Hospital  Department of Endocrinology,Ground floor,98,HAL Airport road,Bangalore-560017,Karnataka
Bangalore
KARNATAKA 		 9886051410

arpan@diabetesendocrinology.in 
Dr Piyush Desai  Nirmal Hospital Private Limited  Department of General Medicine, Ring Road, Surat-395002. Gujarat.
Surat
GUJARAT 		 9825144453

drpiyushdesai@gmail.com 
Dr Neelaveni  Osmania General Hospital  Department of Endocrinology,op building ,2nd floor,Afzalgunji, Hyderabad-500012, Telangana.
Hyderabad
ANDHRA PRADESH 		 9848131182

neelaveni1@yahoo.co.in 
Dr Manoj Chadda  P.D Hinduja Hospital and Medical Research centre  Department of Endocrinology, Veer savarkar marg, Mahim, Mumbai-400016, Maharashtra.
Mumbai
MAHARASHTRA 		 9821548346

mchadha59@gmail.com 
Dr Rajesh Rajput  Pandit Bhagwat Dayal Sharma PGIMS  Department of Endocrinology & Medicine VI  PGIMS, Ward # 09, Medical Road Rohtak-124001, Haryana.
Rohtak
HARYANA 		 9996013454

drrajeshrajput@outlook.com 
Dr Shriraam Mahadevan  Sri Ramachandra Hospital  Department of Endocrinology, No:1, Ramachandra Nagar, Porur, Chennai-600116, Tamil Nadu.
Chennai
TAMIL NADU 		 9840488777

mshriraam@gmail.com 
Dr Sudhakar reddy  Sunshine Hospitals  Department of Endocrinology,Penderghast Road, Opposite Parsi Dharamsala, Paradise, Secunderabad-500003, Telangana.
Hyderabad
ANDHRA PRADESH 		 9848449812

psreddy27@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 16  
Name of Committee  Approval Status 
Drug Trial Ethics Committee  Approved 
Ethics Committee of Manipal Hospitals  Submittted/Under Review 
Ethics committee ,Chellaram diabetes Institute  Approved 
Ethics Committee, Nirmal Hospital Pvt. Ltd  Approved 
Institute Ethics Committee AIMMS    Approved 
Institutional Ethics Committee Apollo Gleneagles  Approved 
Institutional Ethics Committee Deenanth Mangeskar Hospital  Approved 
Institutional Ethics Committee Sri Ramachandra University  Approved 
Institutional Ethics Committee, Endolife Specialty Hospital  Approved 
Institutional Ethics Committee, Government medical college  Approved 
Institutional Ethics Committee, Indian Institute of  Diabetes  Approved 
Institutional Ethics Committee, Osmania Medical College  Approved 
Institutional Ethics Committee, PD Hinduja Hospital and Medical Research Centre  Submittted/Under Review 
Institutional Ethics Committee, PGIMS  Approved 
Institutional Ethics Committee, Sunshine Hospitals  Approved 
Institutional Ethics Committee-Clinical Studies  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Obesity, (1) ICD-10 Condition: E65-E68||Overweight, obesity and other hyperalimentation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  2.4mg placebo once weekly prefilled pen injector for sub cutaneous injection. Total duration of therapy would be 18 months. 
Intervention  Semaglutide  2.4mg Semaglutide once weekly prefilled pen injector for sub cutaneous injection. Total duration of therapy would be 18 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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. Male or female, age ≥ 18 years at the time of signing informed consent
3. Body mass index (BMI) ≥ 30 kg/m2 or ≥ 27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
4. History of at least one self-reported unsuccessful dietary effort to lose body weight 
 
ExclusionCriteria 
Details  Subjects are excluded from the trial if any of the following criteria apply:
Glycaemia-related:
1. HbA1c ≥ 48 mmol/mol (6.5%) as measured by the central laboratory 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 change in body weight > 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 > 1 year before screening, (2) lap banding, if the band has been removed > 1 year before screening, (3) intragastric balloon, if the balloon has been removed > 1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening
8. Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) > 6.0 mIU/L or < 0.4 mIU/L as measured by the central laboratory 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. A Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at screening
12. A lifetime history of a suicidal attempt
13. Suicidal behaviour within 30 days before screening
14. 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:
15. Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening
16. Presence of acute pancreatitis within the past 180 days prior to the day of screening
17. History or presence of chronic pancreatitis
18. Calcitonin ≥ 100 ng/L as measured by the central laboratory at screening
19. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
20. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR < 15 ml/min/1.73 m2 as defined by KDIGO 201268 by the central laboratory at screening
21. 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
22. Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening
23. Subject presently classified as being in New York Heart Association (NYHA) Class IV
24. Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator
25. Known or suspected abuse of alcohol or recreational drugs
26. Known or suspected hypersensitivity to trial product(s) or related products
27. Previous participation in this trial. Participation is defined as signed informed consent
28. Participation in another clinical trial within 90 days before screening
29. Other subject(s) from the same household participating in any semaglutide trial
30. 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
31. Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Change from baseline at week 0 to week 68 in body weight (%)
2. Subjects who after 68 weeks achieve (yes/no):
3. Body weight reduction ≥ 5% from baseline at week  		 68 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Subjects who after 68 weeks achieve  1.Body weight reduction ≥ 10% from baseline at week 0 (68 Weeks)
2.Body weight reduction ≥ 15% from baseline at week 0 (68 Weeks) 
Change from baseline at week 0 to week 68   1. Waist circumference (cm) (68 Weeks)
2. Systolic blood pressure (mmHg) (68 Weeks)
3. Physical functioning score (SF-36) (68 Weeks)
4. Physical function domain (5-items) score (IWQoL-Lite for CT) (68 Weeks)
5. Body weight (kg) (68 Weeks)
6. BMI (kg/m2) (68 Weeks) 
 
Target Sample Size
Modification(s)  		 Total Sample Size="1950"
Sample Size from India="117" 
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)
Modification(s)  		 23/07/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  04/06/2018 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
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   na 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a 68-week, randomised, double-blind, placebo-controlled, two-armed, parallel group, multi-centre, multinational clinical trial comparing semaglutide s.c. 2.4 mg once-weekly with semaglutide placebo once-weekly in subjects with overweight or obesity.                             
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