NCT07234864

Study to Assess Safety, Tolerability, PK, and PD of Multiple Doses of ZE63-0302 Administrated Orally in T2DM Patients.

An Exploratory Randomised, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZE63-0302 in Participants With Type 2 Diabetes Mellitus

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Eilean Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an exploratory randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of 4-week treatment with ZE63-0302 versus placebo in participants with T2DM managed with up to 3 antidiabetic agents (except for insulin). Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence. In this study patients will be enrolled to receive BID of ZE63-0302 or Placebo under fasted condition.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	ZE63-0302	Oral capsules BID
DRUG	Placebo	Oral capsules BID

Timeline

• Start date: 2025-11-19
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2025-11-19
• Last updated: 2026-01-22

Locations

5 sites across 2 countries: Australia, Uzbekistan