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CTRI Number  CTRI/2025/05/086696 [Registered on: 09/05/2025] Trial Registered Prospectively
Last Modified On: 25/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A research study comparing different doses of CDR132L with placebo on the structure and function of the heart in people with heart failure with preserved ejection fraction and left ventricular hypertrophy 
Scientific Title of Study   Phase 2, Multicentre, Randomised, Double-blind, Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodelling in Participants with Heart Failure with Preserved Ejection Fraction and Left Ventricular Hypertrophy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2024-515796-35  EudraCT 
NCT05953831  ClinicalTrials.gov 
NN6706-8212 Version 1.0 dated 21 Nov 2024  Protocol Number 
U1111-1313-3984  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
Modification(s)  
Name  Vijay Parthasarathy 
Designation  Director, CDC India 
Affiliation  Novo Nordisk India Private Limited 
Address  Novo Nordisk India Private Limited, NXT Tower 2, Floor 1 and 2, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli

Bangalore
KARNATAKA
560045
India 
Phone  080 4030 3200   
Fax  080 4112 3518   
Email  VJYP@novonordisk.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Vijay Parthasarathy 
Designation  Director, CDC India 
Affiliation  Novo Nordisk India Private Limited 
Address  Novo Nordisk India Private Limited, NXT Tower 2, Floor 1 and 2, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli

Bangalore
KARNATAKA
560045
India 
Phone  080 4030 3200   
Fax  080 4112 3518   
Email  VJYP@novonordisk.com  
 
Source of Monetary or Material Support  
Novo Nordisk A S Novo Alle, 2880 Bagsvaerd, Denmark 
 
Primary Sponsor  
Name  Novo Nordisk India Private Limited 
Address  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     Canada
Germany
Japan
Poland
Republic of Korea
United States of America
India
United Kingdom
Spain  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gunjan Ghodeshwar  All India Institute of Medical Sciences  Nagpur, Plot No. 2, Sector - 20, MIHAN, Nagpur, Maharashtra, Pin: 441108
Nagpur
MAHARASHTRA 		 9902594923

gunjan.ghodeshwar@aiimsnagpur.edu.in 
Dr Abraham Oomman  Apollo Hospitals  21,Greams lane ,Off Greams Road,Chennai-600006
Chennai
TAMIL NADU 		 9841174578

drabrahamoomman@gmail.com 
Dr Vimal Mehta  G.B. Pant Institute of Postgraduate Medical Education & Research  Jawahar Lal Nehru Marg, New Delhi-110002
New Delhi
DELHI 		 9718599105

drvimalmehta@yahoo.co.in 
Dr Gouranga Sarkar  IPGMER and SSKM HOSPITAL  264,AJC BOSE ROAD, RONALD ROSS BUILDING, 3rd Floor, KOLKATA-700020
Kolkata
WEST BENGAL 		 8910236595

drgsmed@gmail.com 
Dr Krishna Malakondareddy Parvathareddy  Osmania General Hospital  Department of Cardiology, Osmania General Hospital, 15-5-104, Begum Bazar, Afzal Gunj, Hyderabad, Telangana, India - 500012
Hyderabad
TELANGANA 		 9848015098

drkmkreddyp@yahoo.com 
Dr Nirav Bhalani  Rhythm Heart Institute- A Unit of SLPL  Near Siddharth Bunglows, Sama- Savli Road, Vadodara-390022 Gujarat
Vadodara
GUJARAT 		 8128995863

trial@rhythmheart.com 
Dr Shantanu Sengupta  Sengupta Hospital & Research Institute  Ravinagar Square , Nagpur 440033, India
Nagpur
MAHARASHTRA 		 9923190925

senguptasp@gmail.com 
Dr Tanuj Bhatia  Shri Mahant Indiresh Hospital, Shri Guru Ram Rai Institute of Medical and Health Sciences  Patel Nagar, Dehradun, Uttarakhand, India –248001
Dehradun
UTTARANCHAL 		 9936618283

tanujbhatia21@rediffmail.com 
Dr Jitendra Pal Singh Sawhney  Sir Ganga Ram Hospital  SGRH Marg, Rajinder Nagar, New Delhi-110060, India
New Delhi
DELHI 		 9810059773

jpssawhney@yahoo.com 
Dr Sandeep Bansal  Vardhaman Mahavir Medical College & Safdarjung Hospital  Mahatma Gandhi Road, Safdarjung Campus, Ansari Nagar West New Delhi, Delhi, 110029
New Delhi
DELHI 		 9810543368

drsbansal2000@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Institutional Ethics Committee , Osmania Medical College  Approved 
Institutional Ethics Committee - Vardhaman Mahavir Medical College & Safdarjung Hospital  Approved 
Institutional Ethics Committee for Clinical Trial, All India Institute of Medical Sciences, Nagpur  Approved 
Institutional Ethics Committee MAMC  Approved 
Institutional Ethics Committee, Shri Guru Ram Rai Institute of Medical & Health Sciences  Approved 
Institutional Ethics Committee, SMC and GGH  Submittted/Under Review 
Institutional Ethics Committee-Clinical Studies  Approved 
Research Oversight Committee- IPGMER & SSKM Hospital  Approved 
Rhythm Heart Institute Ethics Committee  Approved 
Sengupta Hospital & Research Institute Ethics Committee  Approved 
Sir Ganga Ram Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I508||Other heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CDR132L  Intervention type:IMP, test product Pharmaceutical form :Lyophilised powder for solution for infusion Route of administration:Intravenous infusion Trial product strength:CDR132L 45.2 mg (free acid) to be reconstituted with sterile 0.9% NaCl (saline) solution Dose and dose frequency: 9.04 mg/kg, once every 4 weeks 4.52 mg/kg, once every 4 weeks 1.36 mg/kg, once every 4 weeks 
Comparator Agent  Placebo  Intervention type: IMP, placebo Pharmaceutical form:Solution for infusion Route of administration:Intravenous infusion Trial product strength :Sterile 0.9% NaCl (saline) solution Dose and dose frequency:Once every 4 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  84.00 Year(s)
Gender  Both 
Details  1.Age 40-84 years (both inclusive) at the time of signing the informed consent.
2.Documented symptomatic HF diagnosed greater than or equal to 90 days prior to screening with at least weekly need for oral diuretic treatment, and New York Heart Association class II−III at screening.
3.Clinically stable and on optimised doses and unchanged drug classes of guideline-directed HF therapy greater than or equal to 30 days prior to randomisation.
4.Left ventricular ejection fraction greater than or equal to 50% as assessed by echocardiography at screening, measured by central laboratory.
5.LVMi greater than 88 g per m2 for female participants and greater than 102 g per m2 for male participants as assessed by echocardiography at screening, using the truncated ellipsoid method measured by central laboratory.
6.LAVi greater than or equal to 29 mL per m2 as assessed by echocardiography at screening, measured by central laboratory.
7.Body mass index 18.5-40 kg per m2 (both inclusive) and body weight less than or equal to 140 kg. Body mass index is calculated in the electronic case report form based on height and body weight at the screening visit (visit 1).
8.NT-proBNP greater than or equal to 300 pg per mL; NT-proBNP greater than or equal to 600 pg per mL if atrial fibrillation or flutter is present at time of screening, measured by central laboratory. 
 
ExclusionCriteria 
Details  1. Estimated glomerular filtration rate less than 30 mL per min per 1.73 m2 at time of screening, measured by central laboratory.
2.Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigator, within 90 days prior to randomisation.
3.Myocardial infarction, unstable angina pectoris or HF hospitalisation within 30 days prior to screening.
4.Participants receiving intravenous HF medications within 30 days prior to randomisation.
5.Participants with CRT, pacemaker or implantable cardioverter-defibrillator.
6.Planned coronary revascularisation, pacemaker or cardioverter-defibrillator or CRT implantation, ablation of cardiac arrythmias and valve repair or replacement at the time of randomisation.
7.Stroke or transient ischemic attack within 12 months prior to randomisation.
8.Participants with potential disruption of the blood-brain barrier (e.g., multiple sclerosis), in the opinion of the investigator.
9.Known history of severe liver disease and/or alanine aminotransferase or aspartate aminotransferase greater than 2.5 x upper limit of normal at screening, measured by central laboratory.
10.Known genetic cause of increased cardiac mass (including likely pathogenic variants within dilated cardiomyopathy, hypertrophic cardiomyopathy and Fabry disease).
11. Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in miR-132  From baseline (V2) to
week 24 (V14) 
 
Secondary Outcome  
Outcome  TimePoints 
Supportive secondary efficacy:
Change in composite Z-score based on the 3 outcome measures LVMi(CMR),LAVi (CMR)
and NT-proBNP

Change in miR-132


Supportive secondary safety:
Number of adverse events

Extension phase
Number of adverse events
 		 From baseline (V2) to
week 24 (V14) 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="40" 
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)   01/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
This is an interventional multinational, multicentre, randomised, parallel, double-blind, placebo-controlled study.

The overall purpose of the present phase 2 study is to investigate the efficacy and safety of CDR132L in adult participants with heart failure with preserved ejection fraction (HFpEF) and left ventricular hypertrophy (LVH), as an add-on to standard of care (SoC) therapy. 

The study comprises a 48-week treatment period consisting of a 24-week main phase followed by a 24-week extension phase, and a 12-week follow-up period.
The main phase is designed to investigate:

1. the efficacy of CDR132L on suppression of plasma microRNA-132-3p (miR-132) levels
2. which dose of CDR132L is optimal for reducing plasma levels of miR-132 in this patient population.
3. the efficacy of CDR132L on inducing cardiac reverse remodelling over a 24-week period as evaluated on a 3-item Z-score composed of left ventricular mass indexed to body surface area (LVMi), left atrial volume indexed to body surface area (LAVi) and N-terminal pro B-type natriuretic peptide (NT-proBNP).

The extension phase is designed to investigate:

1. whether effects on plasma miR-132 levels and 3-item Z-score are observed between weeks 24 and 48 in participants continuing treatment with CDR132L versus changing to placebo in the extension phase
2. if maintenance dosing is needed, and what dose and frequency are required to maintain effects.


 
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