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CTRI Number  CTRI/2024/11/076345 [Registered on: 06/11/2024] Trial Registered Prospectively
Last Modified On: 28/08/2025
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 see if kidney damage in people with chronic kidney disease and type 2 diabetes living with overweight or obesity can be reduced by CagriSema compared to semaglutide, cagrilintide and placebo. 
Scientific Title of Study   Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema 2.4 mg or 2.4 mg) once weekly versus semaglutide 2.4 mg, cagrilintide 2.4 mg and placebo in people with chronic kidney disease and type 2 diabetes living with overweight or obesity 
Trial Acronym  Nil 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
2023-505857-42  EudraCT 
NCT06131372  ClinicalTrials.gov 
NN9388-7700 Study Protocol version 4 dated 17 Feb 2025  Protocol Number 
U1111-1291-5907  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 Maya Sharma 
Designation  Vice President - Clinical, Medical, Regulatory & Pharmacovigilance 
Affiliation  Novo Nordisk India Private Ltd 
Address  Novo Nordisk India Private Limited Nxt Tower 2 Floor 1 & 2 Embassy Manyata Business Park Nagavara Village Kasaba Hobli Bangalore 560045_India

Bangalore
KARNATAKA
560045
India 
Phone  09911497869  
Fax    
Email  yrms@novonordisk.com  
 
Details of Contact Person
Public Query  
Name  Dr Maya Sharma 
Designation  Vice President - Clinical, Medical, Regulatory & Pharmacovigilance 
Affiliation  Novo Nordisk India Private Ltd 
Address  Novo Nordisk India Private Limited Nxt Tower 2 Floor 1 & 2 Embassy Manyata Business Park Nagavara Village Kasaba Hobli Bangalore 560045_India


KARNATAKA
560045
India 
Phone  09911497869  
Fax    
Email  yrms@novonordisk.com  
 
Source of Monetary or Material Support
Modification(s)  
Novo Nordisk AS, Novo Allé, 2880 Bagsvaerd Denmark  
 
Primary Sponsor  
Name  Novo Nordisk India Private Limited 
Address  Novo Nordisk India Private Limited 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     Argentina
Brazil
Canada
France
Greece
Hungary
India
Japan
Poland
Slovakia
Spain
Thailand
United States of America  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M V Sai Krishna  Sunrise Hospital  Sunrise Hospitals Eluru Road Near Swathi press, near Seetharampuram, Seetharampuram, Vijayawada, Andhra Pradesh 520002
Krishna
ANDHRA PRADESH 		 9949105936

drsaikrishnamaddi@gmail.com 
Dr Kongara Srikanth  Endolife Speciality Hospital Pvt Ltd.  Endolife Speciality Hospital Pvt Ltd., D_NO:12_12_94, Old Club Road, Kothapet, Guntur_522001
Guntur
ANDHRA PRADESH 		 9849945577

srikanthendo@gmail.com 
Dr Sreenivasa Murthy L  Lifecare hospital and research centre  Lifecare hospital and research centre First Floor 2748 or 2152 M L N ENCLAVE 16th E Cross 8th Main D Block Next to Corporation Bank SAHAKARNAGAR Bangalore 560092
Bangalore
KARNATAKA 		 9448051046

drlsm@lcrc.in 
Dr V Mohan   Madras Diabetes Research Foundation  Madras Diabetes Research Foundation, Clinical trials Department 1st floor, 4, Conran Smith Road, Gopalapuram, Chennai, Tamil Nadu, 600086
Chennai
TAMIL NADU 		 4443968888

drmohans@diabetes.ind.in 
Dr Sandeep Garg  Maulana Azad Medical College  Room no. 103-104, Department Of Medicine, B L Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi Central, Delhi – 110002
New Delhi
DELHI 		 9968604280

drsandeepgargmamc@gmail.com 
Dr Tushar Bandgar  Seth GS Medical College & KEM Hospital  room no. 103 of OPD,Seth GS Medical College & KEM Hospital, KEM Hospital, Acharya Donde Marg, Parel Mumbai, Maharashtra, 400012
Mumbai
MAHARASHTRA 		 9820025037

drtusharb@gmail.com 
Dr Vivek Ruhela  Shri Mahant Indiresh Hospital   4th Floor, South Block, Shri Mahant Indiresh Hospital Patel Nagar, Dehradun, Uttarakhand 248001
Dehradun
UTTARANCHAL 		 9721104868

vivekruhela@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Insititutional Ethics Committee of Endolife speciality hospitals private limited.  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee   Approved 
Institutional Ethics Committee of Madras Diabetes Research Foundation  Approved 
Institutional Ethics Committee Sunrise Hospital  Approved 
Institutional Ethics Committee-l  Approved 
Lifecare Hospital Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cagrilintide 2.4 mg  Cagrilintide B +placebo semaglutide I, DV3384 peninjector,administration: Subcutaneous injection,once weekly on the same day,duration of the study 35 weeks. 
Intervention  CagriSema 2,4 per 2.4   Cagrilintide B +semaglutide I,DV3384 pen-injector, administration: Subcutaneous injection,once weekly on the same day,duration of the study 35 weeks. 
Comparator Agent  Placebo 2.4 mg  Placebo cagrilintide B + placebo semaglutide I, DV3384 pen-injector, administration: Subcutaneous injection,once weekly on the same day,duration of the study 35 weeks. 
Comparator Agent  Semaglutide 2.4mg  Placebo cagrilintide B + semaglutide Ia,DV3384 pen injector, administration: Subcutaneous injection,once weekly on the same day,duration of the study 35 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female.
2. Age 18 years or above at the time of signing the informed consent.
3. Diagnosed with type 2 diabetes mellitus less than or equal to 180 days before screening.
4.BMI more than or equal to 27.0 kg per m2 at screening. BMI will be calculated in the eCRF based on height and body weight at screening.
5. HbA1c less than or equal to 10.5 percent (91 mmol per mol) as assessed by central laboratory at screening.
6. Kidney impairment defined by serum creatinine and cystatin C-based eGFR more than or equal to 15 and less than 90 mL per min per 1.73 m2 (CKD-EPI 2021) as assessed by central laboratory at screening.
7. Albuminuria defined by UACR more than or equal to 100 and less than 5000 mg per ga as assessed by central laboratory at screening.
8. Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme
(ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is
contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be
stable for at least 30 days prior to screening. 
 
ExclusionCriteria 
Details  1. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing
potential and not using a highly effective contraceptive method.
2. Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune
kidney diseases including glomerulonephritis or congenital urinary tract malformations.
3. Use of any GLP-1RA (including medication with GLP-1RA activity, e.g., GIP or GLP-1RA)
or amylin analogue within 60 days prior to screening.
4. Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable
angina pectoris within 60 days before screening.
5. Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
6. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a
fundus examination performed within 90 days before 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.
7. Presence or history of malignant neoplasms or in situ carcinomas (other than basal or
squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or
carcinoma in situ or high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before
screening.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To investigate whether CagriSema 2.4 mg per 2.4 mg versus semaglutide 2.4 mg, cagrilintide 2.4 mg and
placebo improves surrogate markers of CKD progression in participants with T2D - Change in UACR 		 From baseline
(week 0) to end of
treatment (week 26) 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of CagriSema 2.4 mg per 2.4 mg versus semaglutide 2.4 mg, cagrilintide 2.4 mg and placebo with respect to Weight-related parameters  From baseline
(week 0) to end of
treatment (week 26) 
To compare the effect of CagriSema 2.4 mg per 2.4 mg versus semaglutide 2.4 mg, cagrilintide 2.4 mg and placebo with respect to Glycaemic control  From baseline
(week 0) to end of
treatment (week 26) 
To compare the effect of CagriSema 2.4 mg per 2.4 mg versus semaglutide 2.4 mg, cagrilintide 2.4 mg and placebo with respect to Blood pressure  From baseline
(week 0) to end of
treatment (week 26) 
to compare the effect of CagriSema 2.4 mg per 2.4 mg versus semaglutide 2.4 mg, cagrilintide 2.4 mg and placebo with respect to Safety and tolerability  From baseline
(week 0) to end of study
(week 32) 
 
Target Sample Size   Total Sample Size="618"
Sample Size from India="50" 
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)
Modification(s)  		 15/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/04/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="1"
Days="2" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  
CagriSema is currently under development by Novo Nordisk for indications within weight management, T2D, and cardiovascular disease, and is further being considered for the development in heart failure with preserved ejection fraction (HFpEF), nonalcoholic steatohepatitis (NASH), and alcoholic liver disease (ALD).
The proposed study is in accordance with the regulatory guidelines for developing fixed dose combination medicinal products to show the contribution of each monocomponent to the claimed effects within a new indication. To support this, the study tests CagriSema 2.4 mg/2.4 mg as well as the individual contribution from semaglutide 2.4 mg and cagrilintide 2.4 mg to placebo to substantiate effects of both monocomponents for the treatment of chronic kidney disease in people
with T2D, CKD and overweight or obesity.
 
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