Actively Recruiting
A Phase 1b Study of QX1206 in T2DM Patients With NAFLD
Led by 1Globe Health Institute · Updated on 2025-01-13
52
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1b Study of QX1206 in T2DM Patients With NAFLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent must be obtained and documented
- Age between 18 and less than 65 years old
- Body mass index (BMI) at least 18 kg/m2 and less than 45 kg/m2
- Diagnosed with Type 2 Diabetes Mellitus according to 2021 American Diabetes Association criteria
- Diagnosed with Non-Alcoholic Fatty Liver Disease
- Agree to use contraception or take measures to avoid pregnancy during the study if of childbearing potential
- Women of child-bearing potential must have a negative pregnancy test
- Serum creatinine less than 1.5 times upper limit of normal or creatinine clearance at least 60 ml/min
- Able to comply with all study requirements and protocol compliance ensured by study center
You will not qualify if you...
- Uncontrolled diabetes
- Active, serious medical disease limiting daily activities
- Current significant alcohol consumption or history of significant alcohol consumption
- Laboratory abnormalities including:
- Fasting triglycerides over 500 mg/dL
- Fasting direct LDL-C over 190 mg/dL
- AST over 5 times upper limit of normal
- ALT over 5 times upper limit of normal
- Alkaline phosphatase (ALP) at least 2 times upper limit of normal
- HbA1c over 10.5%
- Fasting plasma glucose over 240 mg/dL
- Platelet count below 140,000/mm3
- Use of drugs associated with NAFLD or known liver toxins
- Use of treatments or supplements with potential anti-NAFLD effects (e.g., vitamin E over 400 IU/day)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Centricity Research Toronto LMC.
Toronto, Canada
Actively Recruiting
Research Team
1
1Globe Health Institute
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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