Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects

This clinical trial is a phase 2, double-blind dose escalation regimen of once-weekly
OPK-88003 in subjects with T2DM. The trial consists of four phases: a screening/baseline
phase (up to 2 weeks prior to first dose), a 30-week treatment period consisting of a dose
escalation phase (8 weeks) and a target dose phase (22 weeks), and a follow-up period (4
weeks). Subjects will be randomly assigned to volume-matched OPK-88003 or placebo
administered QW.

Inclusion Criteria:

- Men or women aged 18 to 80 years with T2DM treated with diet and exercise alone or on
a stable dose of metformin (≥ 1000 mg/day),

- BMI ≥27 and ≤45 kg/m2

- HbA1c ≥7.0% and ≤10.5% at screening

Exclusion Criteria:

- Type 1 diabetes mellitus

- Previous treatment with incretin mimetic drugs

- Have used insulin for diabetic control for more than 6 consecutive days within the
prior year

- Have had two or more emergency room visits or hospitalizations due to poor glucose
control within the prior 6 months

- Have a history of acute or chronic pancreatitis or elevation in serum lipase/amylase
(>2 x ULN).