RecruitingPhase 1NCT06694935

A Phase 1b Study of QX1206 in T2DM Patients With NAFLD

A Phase 1b Study of QX1206 in Type 2 Diabetes Mellitus (T2DM) Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)


Sponsor

1Globe Health Institute

Enrollment

52 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label phase 1b trial of QX1206 in patients with T2DM and with NAFLD. Laboratory tests and other measurements will be assessed prior to the first dose of study treatment and throughout the study to determine the recommended phase 2 dose. In addition, the preliminary effects of QX1206 on antidiabetic activity and other metabolic parameters will also be evaluated.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1b study is testing a new experimental drug called QX1206 in people with type 2 diabetes who also have non-alcoholic fatty liver disease (NAFLD) — a condition where too much fat builds up in the liver. The study is assessing whether the drug is safe and what dose is appropriate. **You may be eligible if...** - You are between 18 and 64 years old - You have been diagnosed with type 2 diabetes and non-alcoholic fatty liver disease (NAFLD) - Your BMI is between 18 and 45 kg/m² - Your blood sugar is not severely uncontrolled (HbA1c below 10.5%) - Your liver enzyme levels and kidney function are within acceptable ranges - You are willing to use contraception if of childbearing potential **You may NOT be eligible if...** - Your diabetes is poorly controlled - You have a serious medical condition limiting daily activities - You drink alcohol heavily - Your liver enzymes are more than 5 times the upper limit of normal - Your triglycerides are very high (above 500 mg/dL) - You take medications that are known to cause fatty liver - You are pregnant or breastfeeding 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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Interventions

DRUGQX1206

QX1206 will be administered orally before bedtime


Locations(1)

Centricity Research Toronto LMC.

Toronto, Canada

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NCT06694935


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