| CTRI Number |
CTRI/2021/11/038164 [Registered on: 22/11/2021] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Research study to look at how well semaglutide works in people living
with heart failure, obesity and type 2 diabetes. |
|
Scientific Title of Study
|
Effect of Semaglutide 2.4 mg once-weekly on function and symptoms in subjects with obesityrelated
heart failure with preserved ejection fraction, and type 2 diabetes |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 2020-004170-22 |
EudraCT |
| EX9536-4773 |
ClinicalTrials.gov |
| EX9536-4773 Ver 7.0 final dated 09 Sep 2022 |
Protocol Number |
| NCT04916470 |
ClinicalTrials.gov |
| U1111-1257-5069 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V K Chopra |
| Designation |
Principal Investigator |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital
Department of Cardilogy
1st floor
Saket East block
New Delhi
New Delhi
DELHI
110017
India |
| Phone |
9650896800 |
| Fax |
|
| Email |
Vijay.Chopra@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Maya Sharma |
| Designation |
Vice President-Clinical, Medical, Regulatory and Pharmacovigilance |
| 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,India
Bangalore
KARNATAKA
560045
India |
| Phone |
09911497869 |
| Fax |
|
| Email |
yrms@novonordisk.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Maya Sharma |
| Designation |
Vice President-Clinical, Medical, Regulatory and Pharmacovigilance |
| 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,India
Bangalore
KARNATAKA
560045
India |
| Phone |
09911497869 |
| Fax |
|
| Email |
yrms@novonordisk.com |
|
|
Source of Monetary or Material Support
|
| Novo Nordisk A/S Novo Alle 2880 Bagsvaerd Denmark |
|
Primary Sponsor
Modification(s)
|
| Name |
Novo Nordisk AS |
| Address |
Novo Alle
2880 Bagsværd
Denmark |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Argentina
Austria
Canada
Germany
Hungary
Israel
Italy
Japan
Netherlands
Poland
Spain
Sweden
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abraham Oomman |
Apollo Hospital |
Room No 21,off Greams Road Chennai 600 006, Tamil Nadu
Chennai
TAMIL NADU |
9841174578
drabrahamoomman@gmail.com |
| Dr Vimal Mehta |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research |
Room No-133, 1st Floor, Academic Block,
Department of Cardiology,
New Delhi 110002, India
New Delhi
DELHI |
9718599105
drvimalmehta@yahoo.co.in |
| Dr Pravesh Vishwakarma |
King George’s Medical University |
Department of Cardiology,
King George’s Medical Hospital,
Lucknow,
Uttar Pradesh 226003, India
Lucknow
UTTAR PRADESH |
8756104004
Parveshvishwakarma@kgmcindia.edu |
| Dr Jabir Abdullakutty |
Lisie Hospital |
Lisie Hospital, P.B.No 3053, Cochin-682018, Kerala, India.
Ernakulam
KERALA |
9447011773
drjabi@yahoo.co.in |
| Dr V K Chopra |
Max Super Speciality Hospital |
East block, 1st floor, Saket, New Delhi, 110017 India
New Delhi
DELHI |
9650896800
Vijay.Chopra@maxhealthcare.com |
| Dr D K A garwal |
S. P. Medical College & P.B.M. Hospital |
Research Cell, B-Block, Department of Cardiology, Bikaner-334003, Rajasthan, India
Bikaner
RAJASTHAN |
9829217899
tippy1234@rediffmail.com |
| Dr Jitendra Pal Singh Sawhney |
Sir Ganga Ram Hospital |
Department of cardiology, Rajinder Nagar, New Delhi
110060, India
New Delhi
DELHI |
9810059773
jpssawhney@yahoo.com |
| Dr Sandeep Bansal |
Vardhaman Mahavir Medical College & Safdarjung Hospital |
7th Floor, Department Super Specialty block, New Delhi 110029, India
New Delhi
DELHI |
9810543368
drsbansal2000@yahoo.com |
| Dr Vinod Vijan |
Vijan Cardiac & Critical Care Centre |
Department of Cardiology
Nashik, 422005 India
Nashik
MAHARASHTRA |
9822025353
vmvijan@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics Committee, SP Medical College & A.G. Hospital |
Approved |
| Institutional Ethics Committee - Clinical Studies, Apollo Hospitals Enterprise Limited |
Approved |
| Institutional Ethics Committee MAMC Maulana Azad Medical College |
Approved |
| Institutional Ethics Committee Service Floor, Next to Conference room Max Super Speciality Hospital |
Approved |
| Institutional Ethics Committee VMMC and SJH VMMC And SAFDARJUNG HOSPITAL |
Approved |
| Institutional Ethics Committee, King Georges Medical University |
Approved |
| Lisie Hospital |
Approved |
| Sri Ganga Ram Hospital Ethics Committee |
Approved |
| Vijan Hospital Ethics Committee, Vijan Cardiac and Critical Care Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Semaglutide |
Dose- Semaglutide 2.4 mg
Route of Adminnistration- once-weekly
Duration of therapy- sub cutaneous injection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male or female, age above or equal to 18 years at the time of signing informed consent.
Body mass index (BMI) ≥ 30.0 kg/m2
New York Heart Association (NYHA) Class II-IV
Left ventricular ejection fraction (LVEF) ≥ 45% at screening
Diagnosed with T2D ≥ 90 days prior to the day of screening
HbA1c of ≤ 10.0% as measured at the screening visit |
|
| ExclusionCriteria |
| Details |
A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening
irrespective of medical records
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus
examination performed within 90 days prior to screening or in the period between screening and
randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus
photography camera specified for non-dilated examination. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1- Change in KCCQ clinical summary
score
2- Change in body weight
The 6MWT must be performed in accordance with the manual provided by Novo Nordisk |
1) Time frame-From baseline (week 0) to end of
treatment (week 52)
Unit- Score (no unit, range; 0-100)
2) Time frame: From baseline (week 0) to end of
treatment (week 52)
Unit: % |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in C-Reactive Protein |
From baseline (week -2) to end of treatment (week 52) |
| Change in 6-minute walking distance |
From baseline (week 0) to end of
treatment (week 52) |
|
|
Target Sample Size
|
Total Sample Size="610"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "617"
Final Enrollment numbers achieved (India)="55" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/11/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/06/2021 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a 52-week, randomised, placebo-controlled, double-blinded, multi-centre clinical trial comparing semaglutide s.c. 2.4 mg with placebo in subjects with obesity-related HFpEF and T2D. Eligible subjects will be randomised in a 1:1 manner to receive either semaglutide s.c. 2.4 mg or placebo once-weekly as add-on to standard of care. |