Novo Nordisk Told to Increase Indian Patient Enrollment for Ziltivekimab Study

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-06-19T19:36:18+05:30 | Updated On 19 Jun 2025 7:36 PM IST

New Delhi: In response to a proposal by Novo Nordisk, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended increasing the number of Indian subjects from 700 to 1000 in the Ziltivekimab C 30 mg/mL/placebo study, conducted under Protocol No. EX6018-4979.

The recommendation was made during the SEC (Cardiovascular) meeting held on 5th June 2025, after the company presented its updated proposal requesting an increase in the number of subjects from India 700 to 1000 protocol no. EX6018-4979.

Ziltivekimab is a fully human monoclonal antibody classified as an anti-inflammatory agent. It functions as an interleukin-6 (IL-6) ligand inhibitor, targeting IL-6, a cytokine involved in systemic inflammation, and is being explored for its potential in cardiovascular risk reduction.

Following detailed deliberation, the expert panel recommended approval for the proposed increase in the number of Indian participants enrolled in the ongoing study from India 700 to 1000.

Also Read: Cipla Gets CDSCO Panel Nod To BE Study, Phase III Trial of Semaglutide for Weight Management

ziltivekimabNovoNordiskcdscocardiovascular drugnovo nordiskclinical trial india

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751