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

NCT06694935 | Recruiting Phase 1

• 1 other identifier: T2DM-QX1206-1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Non-Alcoholic Fatty Liver Disease (NAFLD)

Outcome Measures

Primary Outcomes (1)

• Recommended Phase 2 Dose (RP2D)

  Baseline Day 1 up to Week 12

Secondary Outcomes (4)

• Hemoglobin A1c (HbA1c)

  12 Weeks

• Fasting plasma glucose (FPG)

  12 Weeks

• Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

  12 Weeks

• Fasting insulin

  12 Weeks

Study Arms (1)

QX1206

EXPERIMENTAL

Drug: QX1206

Interventions

QX1206 DRUG

QX1206 will be administered orally before bedtime

QX1206

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed written informed consent must be obtained and documented
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• 1Globe Health Institute: lead

Study Sites (1)

Centricity Research Toronto LMC.

Toronto, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Andrew Keates, PhD

  1Globe Health Institute

  STUDY DIRECTOR

Central Study Contacts

1Globe Health Institute

CONTACT

617-649-1157; T2DM-QX1206-1_Study@1globe-usa.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 19, 2024
• Study Start: January 6, 2025
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

CA (1)