An Integrated Assessment of the Safety and Effectiveness of Bexagliflozin for the Management of Essential Hypertension

THR-1442-C-603 is an integrated assessment of the potential utility of bexagliflozin tablets,
20 mg for the treatment of essential hypertension. It is composed of two studies, 603A and
603B, measuring effects in a common population.

Approximately 680 male or female adult subjects who exhibit an office seated blood pressure
≥140 mm Hg and <180 mm Hg, and who are taking no more than 4 anti-hypertension medications
will be enrolled in study 603A.

Upon returning to the investigational site to surrender the ambulatory monitor at the
conclusion of study 603A, subjects will begin participation in study 603B. They will receive
a 12-week supply of bexagliflozin tablets, 20 mg. At week 12 (cumulative week 24) subjects
will visit the investigational site to consume the bexagliflozin tablet and to be fitted with
an ambulatory monitor to record their baseline mean blood pressure. The following day,
subjects will be randomized 1:1 to receive a 12-week supply of bexagliflozin tablets, 20 mg
or bexagliflozin tablets, placebo. Assignment to the active or placebo arm will be balanced.

An assessment of bexagliflozin population pharmacokinetics (PK) will also be conducted, to
include approximately 200 subjects.

Key Inclusion Criteria:

- Male or female with age 20 years or older

- Diagnosed with essential hypertension

- Not taking medication or taking no more than 4 medications for hypertension

Key Exclusion Criteria:

- Requiring insulin to control blood glucose

- Having previously participated in a bexagliflozin or EGT0001474 study