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Novo Nordisk Gets CDSCO Panel Nod to Study new medicine NNC0519-0130
New Delhi: The drug major Novo Nordisk has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase 2 clinical trial for the new antidiabetic drug NNC0519-0130.
This came after Novo Nordisk presented Phase 2 clinical study protocol No.: NN9541-4945 version 2.0 dated 08 January 2024. This is a research study comparing how well different doses of the medicine NNC0519-0130 lower blood sugar in people with type 2 diabetes.
This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment the participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under the skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks.
NNC0519-0130 is a new medicine that may possibly help participants with type 2 diabetes, as it is expected to lower elevated sugar levels in the blood. The medicine may also lower the appetite. This could help reduce overweight which is often present in participants with type 2 diabetes.
At the recent SEC meeting for Endocrinology and Metabolism held on 7th March 2024, the expert panel reviewed the Phase 2 clinical study protocol No.: NN9541-4945 version 2.0 dated 08 January 2024.
After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.
Also Read: Submit Current Safety Data of Indians: CDSCO Panel Tells Glenmark on anti-cancer drug ISB1442
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-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