RecruitingPhase 1NCT07234864

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

Sponsor

Eilean Therapeutics

Enrollment

60 participants

Start Date

Nov 19, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and how a new oral drug called ZE63-0302 behaves in the body when taken over multiple doses in people with Type 2 diabetes who are not well-controlled on their current medications. **You may be eligible if...** - You are between 18 and 65 years old - You have had Type 2 diabetes for at least 7 years - Your blood sugar (HbA1c) is between 7.5% and 9.5% - You are on up to 3 diabetes medications (not insulin) and your dose has been stable for at least 3 months - Your BMI is between 22.5 and 38.5 **You may NOT be eligible if...** - You use insulin - You have had major blood sugar changes recently - You have significant kidney, liver, or heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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