A Phase 1b Study of QX1206 in T2DM Patients With NAFLD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QX1206.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus (T2DM), Non-Alcoholic Fatty Liver Disease (NAFLD). Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1b Study of QX1206 in Type 2 Diabetes Mellitus (T2DM) Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
Overview
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
- Drug QX1206
QX1206 will be administered orally before bedtime
Primary outcome measures
- Recommended Phase 2 Dose (RP2D) [Time frame: Baseline Day 1 up to Week 12]
Secondary outcome measures (4)
- Hemoglobin A1c (HbA1c) [Time frame: 12 Weeks]
- Fasting plasma glucose (FPG) [Time frame: 12 Weeks]
- Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) [Time frame: 12 Weeks]
- Fasting insulin [Time frame: 12 Weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Centricity Research Toronto LMC. — Toronto
Identifiers
NCT: NCT06694935 · T2DM-QX1206-1