Novo Nordisk Told to Increase Indian Patient Enrollment for Ziltivekimab Study
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.
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