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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
QX1206
DrugQX1206 will be administered orally before bedtime
Treatment groups
52 Participants
are divided into 1 treatment groupGroup A: QX1206Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recommended Phase 2 Dose (RP2D)
Time frame
Baseline Day 1 up to Week 12Secondary outcomes
1
Hemoglobin A1c (HbA1c)
Change in HbA1c percentage from baseline with QX1206
Time frame
12 Weeks2
Fasting plasma glucose (FPG)
Change in FPG mg/dL from baseline with QX1206
Time frame
12 Weeks3
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Change in the HOMA-IR from baseline with QX1206
Time frame
12 Weeks4
Fasting insulin
Change in fasting insulin pmol/L from baseline with QX1206
Time frame
12 WeeksSponsors and contacts
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Source ClinicalTrials.gov