Study to Assess Safety, Tolerability, PK, and PD of Multiple Doses of ZE63-0302 Administrated Ora… (NCT07234864) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study to Assess Safety, Tolerability, PK, and PD of Multiple Doses of ZE63-0302 Administrated Orally in T2DM Patients.
Australia, New Zealand60 participantsStarted 2025-11-19
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Adult males and females, ≥18 to ≤65 years of age (inclusive) at screening.
✓. Diagnosis of T2DM of at least 7 years at the time of screening.
✓. 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.
✓. Must have HbA1c ≥7.5% and ≤9.5% at the screening visit.
✓. 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.
✓. Female volunteers:
✓. Must be of non-childbearing potential, i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle stimulating hormone \[FSH\] level consistent with postmenopausal status, per local laboratory guidelines), or
Exclusion criteria
✕. Diagnosis of diabetes other than T2DM (e.g., type 1 diabetes, latent autoimmune diabetes of adults, monogenic diabetes, gestational diabetes) or at least one of the following at screening:
✕
What they're measuring
1
Incidence of AE/SAE.
Timeframe: From dosing to Week 4.
2
Change from baseline throughout the study in the vital signs and physical examination findings.
Timeframe: From dosing to Week 4.
3
Change from baseline throughout the study in 12-lead electrocardiogram results
Timeframe: From dosing to Week 4
4
Change from baseline throughout the study in Clinical laboratory assessments.
✕. Treatment with insulin within 3 months prior to or during screening.
✕. Severe hypoglycaemia (defined as the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery), hypoglycaemia unawareness, diabetic ketoacidosis, or non-ketotic hyperosmolar state within 3 months of screening.
✕. Use of weight loss agents (Section 21.2) or diet (hypocaloric diet), unless the diet or weight loss treatment (prescription, herbal, over-the-counter, or other) has been stopped at least 3 months prior to screening and the participant has had stable (± 5%) body weight within the previous 3 months of screening.
✕. Chronic systemic corticosteroid use, defined as any daily dose \>10 mg prednisone or equivalent, for more than 2 consecutive weeks within 3 months prior to or during screening.
✕. Any use of hepatotoxic drugs (e.g., statins), gastric acid reducing medications, medications metabolized via the cytochrome P450 system (e.g., P-gp inhibitors, antifungal agents \[ketoconazole, itraconazole\], macrolides \[erythromycin, clarithromycin\], calcium channel blockers \[verapamil, diltiazem\], or medications with the potential for drug-drug interactions) within 3 months of screening.