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

January 9, 2025 updated by: 1Globe Health Institute

A Phase 1b Study of QX1206 in Type 2 Diabetes Mellitus (T2DM) Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QX1206
Drug: QX1206
QX1206 will be administered orally before bedtime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recommended Phase 2 Dose (RP2D)
Time Frame: Baseline Day 1 up to Week 12
Baseline Day 1 up to Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

1Globe Health Institute

Investigators

  • Study Director: Andrew Keates, PhD, 1Globe Health Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Actual)

November 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T2DM-QX1206-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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