A Phase 1b Study of QX1206 in T2DM Patients With NAFLD
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
Sponsor1Globe Health Institute
About this trial
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.
Eligibility criteria
Qualifiers
Signed written informed consent must be obtained and documented
18 years of age and < 65 years old
BMI ≥ 18 kg/m² and < 45 kg/m²
T2DM diagnosed per 2021 American Diabetes Association criteria
Disqualifiers
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
Fasting triglycerides > 500 mg/dL
Trial design
Treatments tested in this trial
- QX1206
Treatment groups
52 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov