Virchow Biotech gets CDSCO panel nod to study Semaglutide for chronic weight management
New Delhi: Recommending modifications in the protocol, the Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organisation (CDSCO), has granted approval to Virchow Biotech for conducting the bioequivalence and phase III clinical study of Semaglutide (Synthetic Origin) for chronic weight management.
This came after Virchow Biotech presented preclinical study reports and the bioequivalence study protocol (Protocol No.: AR088-25, Version No.: 01, Date: 09.05.2025) along with the Phase III clinical trial protocol (Protocol No.: VBSEMA-WM/2025-CT1, Version No.: 1, Date: 05.05.2025) for chronic weight management before the committee.
The expert panel recommended that the study protocol be revised to include thyroid screening for Medullary Carcinoma of the Thyroid (MTC) by ultrasound as part of subject eligibility criteria, incorporate a cautionary note regarding MTC in the Informed Consent Form, and add a one-month follow-up period after completion of the CT study.
Semaglutide is a glucagon-like peptide 1 receptor agonist used to improve glycemic control in type 2 diabetes mellitus, treat obesity, and reduce the risk of major adverse cardiovascular events in selected adults.
GLP-1 is a physiological hormone that promotes glycemic control via several different mechanisms, including insulin secretion, slowing gastric emptying, and reducing postprandial glucagon secretion. The homeostasis of glucose is dependent on hormones such as insulin and amylin, which are secreted by the beta cells of the pancreas.
Semaglutide is 94% similar to human GLP-1. Analogs of this hormone, such as semaglutide, stimulate the synthesis of insulin by stimulating pancreatic islet cells and reducing glucagon secretion.They directly bind with selectivity to the GLP-1 receptor, causing various beneficial downstream effects that reduce blood glucose in a glucose-dependent fashion.
In hypercholesterolemia, semaglutide is believed to reduce the progression of atherosclerosis via decreased gut permeability and decreased inflammation. Weight loss is believed to occur via the reduction of appetite and food cravings after semaglutide administration.
At the recent SEC meeting for endocrinology and metabolism, the expert panel reviewed the preclinical study reports and the bioequivalence study protocol along with the Phase III clinical trial protocol presented by Virchow Biotech.
After detailed deliberation, the committee recommended the grant of permission to conduct the BE study and Phase III clinical trial with the following change in the clinical trial (CT) protocol:
1. Thyroid screening for medullary carcinoma Thyroid by ultrasound should be part of screening for subject eligibility.
2. Caution for medullary thyroid carcinoma (MTC) should be part of the informed consent form.
3. After completion of the CT study, a one-month follow-up period should be included in the protocol.
In addition to the above, the expert panel stated that the firm should submit a BE study report to CDSCO and the BE report should be evaluated by the committee before the initiation of the Phase III clinical trial.
