AstraZeneca's Proposal to Increase Sample Size in Zibotentan-Dapagliflozin Global Trial Gets SEC Nod

In its latest submission, the firm sought approval for increasing the sample size of the trial from 1,500 to 1,800 participants. Justification for the amendment was presented to the committee as part of the revised protocol documents.

The study involves the evaluation of Zibotentan 0.25 mg + Dapagliflozin 10 mg and Zibotentan 0.75 mg + Dapagliflozin 10 mg.

AstraZeneca Pharma India Limited, headquartered in Bengaluru, is a subsidiary of AstraZeneca UK. The company focuses on major therapeutic areas including oncology, cardiovascular, renal, and metabolic diseases, and has an established presence in India through research partnerships and marketed products such as Dapagliflozin under the brand name Forxiga.

Zibotentan is an endothelin receptor antagonist being developed by AstraZeneca, while Dapagliflozin is a well-established SGLT2 inhibitor used in the management of type-2 diabetes, chronic kidney disease, and heart failure. The combination aims to provide enhanced renoprotection and address unmet needs in patients at risk of progression of renal disease.

After detailed deliberation, the SEC recommended approval of the protocol amendment for the increased sample size as presented by the firm.

This will allow AstraZeneca to recruit additional participants, thereby strengthening the trial’s ability to generate robust safety and efficacy data to support further regulatory submissions.