A Phase 1b Study of QX1206 in T2DM Patients With NAFLD

Phase 1

Recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM); Non-Alcoholic Fatty Liver Disease (NAFLD)
• Interventions: Drug: QX1206

• Registration Number: NCT06694935
• Lead Sponsor: 1Globe Health Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-15
• Study First Posted: 2024-11-19
• Status Verified: 2025-01
• Study Start: 2025-01-06
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Signed written informed consent must be obtained and documented
• 18 years of age and < 65 years old
• BMI ≥ 18 kg/m^2 and < 45 kg/m^2
• T2DM diagnosed per 2021 American Diabetes Association criteria
• Diagnosis of NAFLD
• For male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy during the study
• Women of child-bearing potential (WOCBP) must have a negative pregnancy test
• Serum creatinine < 1.5×ULN or creatinine clearance ≥ 60 ml/min
• Participating patients must be able to comply with all study requirements and the study center must have appropriate means of ensuring protocol compliance for each participating patient

Exclusion Criteria

• 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
• Patients with any of the following clinical laboratory abnormalities at screen and confirmed by a single repeat if deemed necessary:
• Fasting triglycerides > 500 mg/dL
• Fasting direct LDL-C > 190 mg/dL
• AST > 5.0 × upper limit of normal (ULN)
• ALT > 5.0 × ULN
• Alkaline phosphatase (ALP) ≥ 2 × ULN
• HbA1c > 10.5%
• Fasting plasma glucose (FPG) > 240 mg/dL (13.3 mmol/L)
• Platelets count < 140,000/mm^3
• Patient takes drugs historically associated with NAFLD and other known hepatotoxins
• Treatment with drugs (e.g., vitamin E > 400 IU/day) or herbal supplements with potential anti-NAFLD effect

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QX1206	QX1206	-

Primary Outcome Measures

Name	Time	Method
Recommended Phase 2 Dose (RP2D)	Baseline Day 1 up to Week 12

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c)	12 Weeks	Change in HbA1c percentage from baseline with QX1206
Fasting plasma glucose (FPG)	12 Weeks	Change in FPG mg/dL from baseline with QX1206
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	12 Weeks	Change in the HOMA-IR from baseline with QX1206
Fasting insulin	12 Weeks	Change in fasting insulin pmol/L from baseline with QX1206

Trial Locations

Locations (1)

Centricity Research Toronto LMC.; 🇨🇦 Toronto, Canada