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
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.