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.

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