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CTRI Number  CTRI/2025/05/087905 [Registered on: 30/05/2025] 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 CDR132L with placebo on the structure and function of the heart in people with heart failure with reduced/mildly reduced 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 Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2024-515797-27  EudraCT 
NCT05953831  ClinicalTrials.gov 
NN6706-8282_Version 1.0_21 November 2024  Protocol Number 
U1111-1313-4591  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 
Address  Novo Nordisk India Private Limited, Nxt Tower 2, Floor 1 and 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     Australia
Czech Republic
Germany
India
Japan
Netherlands
Poland
Republic of Korea
Spain
United Kingdom  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jaspal Arneja  Arneja Heart & Multispeciality Hospital  Department of Cardiology, Arneja Heart & Multispeciality Hospital, 123, Ramdaspeth, behind Somalwar High School, Nagpur, Maharashtra- 440010
Nagpur
MAHARASHTRA 		 9823066007

jaspalarneja_200@yahoo.com 
Dr Gurpreet S Wander  Dayanand Medical College and Hospital  Research and Development centre. Hero DMC Heart Institute. Dayanand Medical college and hospital. Tagore nagar, civil lines, Ludhiana, Punjab- 141001
Ludhiana
PUNJAB 		 9815545316

drgswander@yahoo.com 
Dr Mohit Gupta  Govind Ballabh Pant Institute of Postgraduate Medical Education and Research  Department of Cardiology, Gate number 2, Jawaharlal Nehru Marg, 64 Khamba, Raj Ghat G B Pant Institute of Postgraduate Medical Education and Research New Delhi- 110002
New Delhi
DELHI 		 9810121311

drmohitgupta@yahoo.com 
Dr Girish Sabnis  K.E.M Hospital and Seth G.S Medical College  Department of Cardiology, 4th Floor, CVTC Building, K.E.M Hospital and Seth G.S Medical College, Acharya Donde Marg, Parel, Mumbai, Maharashtra, India - 400012
Mumbai
MAHARASHTRA 		 9833712374

girishsabnis@live.in 
Dr Jabir Abdullakutty  Lisie Hospital  Dept. of Cardiology, Lisie Hospital P.O. Box No. 3053, Kochi, Kerala-682018
Ernakulam
KERALA 		 9447011773

drjabi@yahoo.co.in 
Dr Nirav Bhalani  Rhythm Heart Institute  Rhythm Heart Institute, Clinical Research Department, Near Siddharth Bungalows, Sama-Savli Road, Vadodara, Gujarat- 390022
Vadodara
GUJARAT 		 8128995863

trial@rhythmheart.com 
Dr Tanuj Bhatia  Shri Guru Ram Rai Institute of Medical and Health Sciences And Shri Mahant Indiresh Hospital  Shri Guru Ram Rai Institute of Medical and Health Sciences And Shri Mahant Indiresh Hospital 4th Floor, South Block, Shri Mahant Indiresh Hospital, Patel Nagar Dehradun, Uttarakhand, India- 248001
Dehradun
UTTARANCHAL 		 8802459589

tanujbhatia21@rediffmail.com 
Dr Ashwani Mehta  Sri Ganga Ram Hospital  Clinical Research Room, First Floor Near Male General Ward, Rajinder Nagar Sri Ganga Ram Hospital-Cardiology New Delhi- 110060
New Delhi
DELHI 		 9811057384

drashwanimehta@gmail.com 
Dr Hermohander Singh Isser  Vardhman Mahavir Medical College and Safdarjung Hospital  Department of Cardiology Room Number 725, 7th Floor, SSB VMMC & Safdarjung Hospital New Delhi-110029
New Delhi
DELHI 		 9899128399

drhsisser@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Arnejas Institutional Ethics committee  Approved 
Drug Trial Ethics Committee Dayanand Medical College & Hospital  Approved 
Institutional Ethic Committee (IEC) Lisie Hospital  Approved 
Institutional Ethics Committee - 1  Approved 
Institutional Ethics Committee MAMC  Approved 
Institutional Ethics Committee, Osmania Medical College  Submittted/Under Review 
Institutional Ethics Committee, Shri Guru Ram Rai Institute of Medical Sciences  Approved 
Institutional Ethics Committee, VMMC and SJH  Approved 
Rhythm Heart 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  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- 4.52 mg/kg, once every 4 weeks  
Comparator Agent  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  85.00 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 180 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. LVEF lesser than 50 percentage 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 lesser 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.eGFR 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.Planned coronary revascularisation, pacemaker/cardioverter-defibrillator/CRT implantation,
ablation of cardiac arrythmias or valve repair/replacement at the time of randomisation.
6.Stroke or transient ischemic attack within 12 months prior to randomisation.
7.Participants with potential disruption of the blood-brain barrier (e.g., multiple sclerosis), in
the opinion of the investigator
8.Known history of severe liver disease and/or alanine aminotransferase or aspartate
aminotransferase greater than 2.5x upper limit of normal at screening, measured by central laboratory
9.Known genetic cause of increased cardiac mass (including likely pathogenic variants within
dilated cardiomyopathy, hypertrophic cardiomyopathy and Fabry disease).
10.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 
To confirm superiority of 4.52 mg/kg CDR132L Q4W versus placebo Q4W, both added to standard of care, on change in miR-132 from baseline to week 24 in participants with HFrEF/HFmrEF and LVH.

Change in miR-132 		 From baseline (V2) to
week 24 (V14) 
 
Secondary Outcome  
Outcome  TimePoints 
Main Phase:
1. To compare the effect of 4.52 mg/kg CDR132L Q4W versus placebo Q4W on the composite Z-score based on the 3 outcome measures LVEDVi, LVESVi and NT-proBNP.
2. To compare the effect of 4.52 mg/kg CDR132L Q4W versus placebo Q4W on safety and tolerability.

Extension Phase:
1. To compare the effect of 4.52 mg/kg CDR132L Q4W versus placebo Q4W on safety and tolerability. 		 Main Phase: From baseline (V2) to week 24 (V14)

Extension Phase: From baseline (V2) to week 60 (V27) 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="20" 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
Synopsis
This is an interventional, multinational, multicentre, randomised, parallel, double-blind,
placebo-controlled study.

Rationale:
The overall purpose of this phase 2 study is to investigate the efficacy and safety of CDR132L in
adult participants with heart failure (HF) with mildly reduced ejection fraction (HFmrEF) and
reduced ejection fraction (HFrEF), i.e., left ventricular ejection fraction (LVEF) less than 50%, 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:
The efficacy of CDR132L on suppression of plasma microRNA-132-3p (miR-132) levels
The efficacy of CDR132L on inducing cardiac reverse remodelling over a 24-week period as
evaluated by a 3-item Z-score composed of left ventricular end-diastolic volume indexed to
body surface area (LVEDVi), left ventricular end-systolic volume indexed to body surface
area (LVESVi) and N-terminal pro B-type natriuretic peptide (NT-proBNP).

The extension phase is designed to investigate:
The efficacy of CDR132L on suppression of plasma miR-132 levels and on inducing cardiac
reverse remodelling as evaluated by the 3-item Z-score after 48 weeks of treatment.

The main phase and extension phase, including the follow-up period, will provide data on safety,
including renal safety in participants with estimated glomerular filtration rate (eGFR) down to
30 mL per min per 1.73 m2, to support selection of the study population for phase 3.
 
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