Study to Assess Safety, Tolerability, PK, and PD of Multiple Doses of ZE63-0302 Administrated Orally in T2DM Patients.
Trial Parameters
Brief Summary
A Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of ZE63-0302 administrated orally in T2DM patients.
Eligibility Criteria
Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects. 2. Adult males and females, ≥18 to ≤65 years of age (inclusive) at screening. 3. Diagnosis of T2DM of at least 7 years at the time of screening. 4. Must be receiving treatment with up to 3 antidiabetic agents (except insulin) at a stable, optimal, or maximum tolerated dose for at least 3 months prior to screening and with no dose changes expected during the study. 5. Must have HbA1c ≥7.5% and ≤9.5% at the screening visit. 6. Must have BMI ≥ 22.5 and ≤38.5 kg/m2 at the screening visit, with stable (± 5%) body weight within the previous 3 months of screening. 7. Female volunteers: 1. Must be of non-childbearing potential, i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening visit or