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QX1206 for Type 2 Diabetes and Fatty Liver Disease
Phase 1
Recruiting
Research Sponsored by 1Globe Health Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Serum creatinine \< 1.5×ULN or creatinine clearance ≥ 60 ml/min
* Diagnosis of NAFLD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called QX1206 in patients with Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease. They will monitor patients' lab tests and measurements before and during
Who is the study for?
This trial is for adults aged 18-65 with Type 2 Diabetes Mellitus (T2DM) and Non-alcoholic Fatty Liver Disease (NAFLD). Participants must meet specific diabetes criteria, have a Body Mass Index (BMI) between 18 and 45, and functionally healthy kidneys. Women who can bear children need a negative pregnancy test and agree to use contraception.
What is being tested?
The study tests QX1206's safety, proper dosage for Phase 2 trials, its effects on blood sugar control, and other metabolic outcomes in T2DM patients with NAFLD. It's an early-stage trial where everyone gets the drug; their health is closely monitored throughout.
What are the potential side effects?
Specific side effects of QX1206 are not listed but may include typical reactions seen with antidiabetic or liver disease treatments such as gastrointestinal discomfort, potential kidney impact, skin reactions or hypoglycemia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine levels, is within normal limits.
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I have been diagnosed with non-alcoholic fatty liver disease.
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I am between 18 and 65 years old.
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I am a woman who can have children and I have a negative pregnancy test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Fasting insulin
Fasting plasma glucose (FPG)
Hemoglobin A1c (HbA1c)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: QX1206Experimental Treatment1 Intervention
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Who is running the clinical trial?
1Globe Health InstituteLead Sponsor
Andrew Keates, PhDStudy Director1Globe Health Institute