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

Launched by 1GLOBE HEALTH INSTITUTE · Nov 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called QX1206 for patients who have both Type 2 Diabetes Mellitus (T2DM) and Non-Alcoholic Fatty Liver Disease (NAFLD). The goal is to find out the safest and most effective dose of QX1206 and to see how it might help with diabetes and other related health issues. If you are between the ages of 18 and 65, have a diagnosis of T2DM and NAFLD, and meet certain health criteria, you may be eligible to participate in this study.

Participants in this trial will receive QX1206 and undergo various tests to monitor their health and the treatment’s effects. To join, you need to agree to follow the study requirements, including using contraception if you are able to have children. This trial is currently recruiting participants, and your involvement could help researchers learn more about potential treatments for T2DM and NAFLD. If you have any questions about the study or your eligibility, it's important to talk to your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed written informed consent must be obtained and documented
• • 18 years of age and \< 65 years old
• • BMI ≥ 18 kg/m\^2 and \< 45 kg/m\^2
• • T2DM diagnosed per 2021 American Diabetes Association criteria
• • Diagnosis of NAFLD
• • For male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy during the study
• • Women of child-bearing potential (WOCBP) must have a negative pregnancy test
• • Serum creatinine \< 1.5×ULN or creatinine clearance ≥ 60 ml/min
• • Participating patients must be able to comply with all study requirements and the study center must have appropriate means of ensuring protocol compliance for each participating patient
• Exclusion Criteria:
• • Uncontrolled diabetes
• • Patients with an active, serious medical disease that limit activities of daily living
• • Patients with current, significant alcohol consumption or a history of significant alcohol consumption
• * Patients with any of the following clinical laboratory abnormalities at screen and confirmed by a single repeat if deemed necessary:
• • Fasting triglycerides \> 500 mg/dL
• • Fasting direct LDL-C \> 190 mg/dL
• • AST \> 5.0 × upper limit of normal (ULN)
• • ALT \> 5.0 × ULN
• • Alkaline phosphatase (ALP) ≥ 2 × ULN
• • HbA1c \> 10.5%
• • Fasting plasma glucose (FPG) \> 240 mg/dL (13.3 mmol/L)
• • Platelets count \< 140,000/mm\^3
• • Patient takes drugs historically associated with NAFLD and other known hepatotoxins
• • Treatment with drugs (e.g., vitamin E \> 400 IU/day) or herbal supplements with potential anti-NAFLD effect