Actively Recruiting
A Phase 1b Study of QX1206 in Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease Patients
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
Researchers are evaluating QX1206 in an open-label phase 1b trial for patients who have Type 2 Diabetes Mellitus (T2DM) and Non-Alcoholic Fatty Liver Disease (NAFLD). The study aims to find the recommended dose for phase 2 and to observe preliminary effects of QX1206 on blood sugar control and other metabolism-related measures. Patients will undergo laboratory tests and other assessments before and during the study to monitor these effects. Participants will take QX1206 orally before bedtime throughout the trial. The study focuses on determining the optimal dose by monitoring patients from the start of treatment through week 12. There are no additional treatment groups or placebo comparators mentioned, as this is an early phase trial primarily assessing dose and safety. During the study, participants will have regular lab tests and evaluations to check how they respond to the treatment and to ensure safety. Researchers will monitor various health markers, including blood sugar and liver function, to assess the impact of QX1206. The total study duration includes baseline measurements before the first dose and continued monitoring up to 12 weeks.
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
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Trial Site Locations
Total: 1 location
1
Centricity Research Toronto LMC.
Toronto, Canada
Actively Recruiting
Research Team
1
1Globe Health Institute
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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