NCT07234864
Study to Assess Safety, Tolerability, PK, and PD of Multiple Doses of ZE63-0302 Administrated Orally in T2DM Patients.
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Record History
All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗
Notable Eligibility criteria expanded, about 49 words Show 4 more changesShow less
- Primary endpoints: details revised at 1 of 4 entries
- Trial completed
- Study completion date changed from estimate of Nov 2026 to Jul 9, 2026
- Secondary endpoints: details revised at 7 of 7 entries
- Minor Trial status changed: Recruiting → Active, Not Recruiting
- Trial sites expanded: 5 → 10 locations
- Primary completion moved earlier from Aug 2026 to Apr 21, 2026
- Notable Trial status: Not Yet Recruiting to Recruiting
- Study sites: 4 to 5
- Start date changed from estimate of Nov 2025 to Nov 19, 2025
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Incidence of AE/SAE.
Timeframe: From dosing to Week 4.
Change from baseline throughout the study in the vital signs and physical examination findings.
Timeframe: From dosing to Week 4.
Change from baseline throughout the study in 12-lead electrocardiogram results
Timeframe: From dosing to Week 4
Change from baseline throughout the study in Clinical laboratory assessments.
Timeframe: From dosing to Week 4.
Secondary (7)
Half-life (t1/2) of ZE63-0302
Plasma Cmax
Time to maximum concentration.
Area under the concentration time curve from time 0 to 12 hours
Area under the concentration time curve from time 0 to 6 hours
Show 2 moreShow less
Trough plasma concentration
Accumulation ratio.
Arms and interventions
ZE63-0302 treatmentExperimental
Oral capsules BID
PlaceboPlacebo comparator
Oral capsules BID
Drugs: ZE63-0302, Placebo
Sites
10 sites in 3 countries
New Zealand 5, Australia 4, Uzbekistan 1