CDSCO Panel Approves IQVIA RDS Protocol Amendment Proposal for Survodutide study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by IQVIA RDS (India) to study glucagon/GLP-1 receptor dual agonist Survodutide.
This came after IQVIA RDS (India) presented protocol amendment version 2.0 dated 22 November 2023 and protocol amendment version 3.0 dated 12 January 2024 protocol no. 1404-0040. This is a study to test the effect of Survodutide on cardiovascular safety in people who are overweight or obese.
The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight.
Survodutide is a glucagon/GLP-1 receptor dual agonist that activates both the GLP-1 and glucagon receptors, which are critical to controlling metabolic functions. The dual GCGR/GLP-1R agonist survodutide has been developed to provide greater body weight-lowering efficacy compared with GLP-1R agonists by reducing energy intake and increasing energy expenditure, simultaneously acting on the two principles of energy homeostasis of relevance for regulating body weight.
At the recent SEC meeting for Cardiovascular held on 11th September 2024, the expert panel reviewed the protocol amendment version 2.0 dated 22 November 2023 and protocol amendment version 3.0 dated 12 January 2024 protocol no. 1404-0040.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
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