Tesu Health is pleased to announce that the first patient has been enrolled in the clinical trial (NCT05668819) TH001_1001. The trial evaluates TH-001 versus standard of care in adult patients with prediabetes over a 90-day treatment period with the primary outcome measures being the mean change from baseline in HbA1c (%), FPG (mg/dL), and 2-hour 75 g OGTT (mg/dL) at day 90 between groups.
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In October 2022 Turkish Medicines and Medical Devices Agency of the Ministry of Health granted Tesu Health approval for a prospective, randomized, controlled clinical trial. The study allows Tesu Health to collect safety and effectiveness data to support a CE Mark certification of TH-001 as a medical device upon completion of the study.
The trial is being led by Principal Investigator Seda Sancak Nurdan, MD, Professor of Endocrinology at the Fatih Sultan Mehmet Training and Research Hospital in Istanbul, Turkiye. An important step in the study was achieved when the first patient was enrolled by the Principal Investigator.
Enrolling the first subject in this important trial is another key milestone for Tesu Health’s clinical program, and we are very pleased to be collaborating with the Fatih Sultan Mehmet Training and Research Hospital research team in evaluating our investigational medical device TH-001 in an indication with a significant unmet medical need.
For more information about the clinical trial TH001_1001 please visit ClinicalTrials.gov.