Non-Alcoholic Fatty Liver Disease (NAFLD), Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief 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.
Interventions
DRUGQX1206
QX1206 will be administered orally before bedtime
Sponsors
1Globe Health Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended Phase 2 Dose (RP2D) | Baseline Day 1 up to Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c (HbA1c) | 12 Weeks | Change in HbA1c percentage from baseline with QX1206 |
| Fasting plasma glucose (FPG) | 12 Weeks | Change in FPG mg/dL from baseline with QX1206 |
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 12 Weeks | Change in the HOMA-IR from baseline with QX1206 |
| Fasting insulin | 12 Weeks | Change in fasting insulin pmol/L from baseline with QX1206 |
Countries
Canada
Contacts
Primary Contact1Globe Health Institute
Outcome results
None listed