Macau University of Science and Technology Clinical Trials Centre Reaches A New Milestone
Macao's Second New Drug Clinical Trial Approved for Initiation
The Macau University of Science and Technology Clinical Trials Centre (MUST-CTC) has reached a new milestone. Macao's second international multi-centre new drug clinical trial has received approval from the Macao Pharmaceutical Administration Bureau and has officially launched on 26 March 2026.
Sponsored by Boehringer Ingelheim, an international biopharmaceutical company, and centrally coordinated by MUST-CTC, it is also the second new drug clinical study conducted under the collaboration between the two parties. Just half a year after the launch of Macao's first international multi-centre novel drug trial in August 2025, MUST-CTC has once again received the regulatory approval to conduct a new drug clinical study. This demonstrates Macao's sustainable development capability in clinical research and MUST-CTC’s capacity to undertake high-standard international novel drug trials. This achievement carries significant impact to the advancement of Macao's pharmaceutical and healthcare industry.
The EASi-PROTKT™ trial is a double-blind, randomized, placebo-controlled Phase III study targeting patients with type 2 diabetes, hypertension and cardiovascular diseases. Despite recent progress in the management of type 2 diabetes, chronic kidney diseases and hypertension, an unmet need for effective therapies remains for type 2 diabetes patients with hypertension and cardiovascular diseases. The investigational drug, Vicadrostat (BI 690517), is a selective aldosterone synthase inhibitor (ASi) developed by Boehringer Ingelheim. The study aims to evaluate the efficacy and safety of the combined use of the investigational drug and the diabetes medication, empagliflozin, on top of standard care, in reducing cardiovascular risk and preventing heart failure. This combination therapy is expected to address gaps in current treatment strategies and provide a new therapy for heart failure prevention.
The trial is conducted in approximately 50 countries and regions worldwide, including the Chinese Mainland, Hong Kong SAR and Macao SAR, with a planned recruitment of 11,800 participants globally. The large-scale study data will provide robust scientific evidence for the clinical efficacy and safety of the investigational drugs, benefiting patients worldwide.
The trial is sponsored by Boehringer Ingelheim. MUST-CTC is responsible for coordination of study activities at the study site - University Hospital (UH), and The University of Hong Kong Clinical Trials Centre (HKU-CTC) provides strategic collaborative support. The joint efforts ensure the smooth and high-quality execution of the trial.
Since its establishment, MUST-CTC has been managing and conducting clinical trials in strict accordance with international standards and Good Clinical Practice (GCP) guideline. The successful launch of Macao's second international multi-centre new drug trial will further enhance Macao’s practical experience in clinical research. It lays a foundation for Macao to build an international pharmaceutical R&D cooperation platform to attract more pharmaceutical enterprises and research institutions to the city. Looking forward, as more international clinical trial projects progress, Macao will continue to strengthen the foundations of its healthcare industry, contributing to the development across the Guangdong-Hong Kong-Macao Greater Bay Area.
MUST-CTC/UH Study Team
