Actively Recruiting
A Phase 1b Study of QX1206 in Type 2 Diabetes Mellitus Patients With Non-Alcoholic Fatty Liver Disease
Led by 1Globe Health Institute · Updated on 2025-01-13
52
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating QX1206 in an open-label phase 1b trial involving adults with Type 2 Diabetes Mellitus (T2DM) and Non-Alcoholic Fatty Liver Disease (NAFLD). The study aims to determine the recommended dose for future studies and examine the preliminary effects of QX1206 on blood sugar control and other metabolic factors. Participants will take QX1206 orally before bedtime. The trial will last up to 12 weeks, during which laboratory tests and measurements will be taken before the first dose and throughout the study to monitor effects and safety. The study focuses on finding the best dose and assessing changes in blood sugar and insulin resistance. During the study, participants will undergo regular assessments including blood tests for hemoglobin A1c, fasting glucose, insulin levels, and insulin resistance. Researchers will track the recommended phase 2 dose from day 1 through week 12. Patients must comply with study procedures and attend all visits. The total participation period is up to 12 weeks.
CONDITIONS
Brief 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
- Age between 18 and less than 65 years
- Body mass index (BMI) between 18 and less than 45 kg/m²
- Diagnosed with Type 2 Diabetes Mellitus according to 2021 American Diabetes Association criteria
- Diagnosis of Non-Alcoholic Fatty Liver Disease
- For males or females who can have children: agree to use contraception or avoid pregnancy during the study
- 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
- Ability to follow all study requirements and protocol compliance
You will not qualify if you...
- Uncontrolled diabetes
- Active, serious medical disease limiting daily activities
- Current significant alcohol consumption or history of such
- Certain lab abnormalities including fasting triglycerides over 500 mg/dL, LDL cholesterol over 190 mg/dL, AST or ALT over 5 times upper limit of normal, alkaline phosphatase at least twice upper limit of normal
- Hemoglobin A1c over 10.5%
- Fasting plasma glucose over 240 mg/dL
- Platelet count below 140,000/mm³
- Use of drugs known to cause NAFLD or known liver toxins
- Treatment with drugs or supplements with potential anti-NAFLD effects such as high dose vitamin E
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants take the study drug QX1206 orally before bedtime to treat Type 2 Diabetes Mellitus with Non-Alcoholic Fatty Liver Disease.
Regular visits during 12 weeks of treatment
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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