Type 2 Diabetes Mellitus (T2DM)Phase 1NCT06694935
A Phase 1b Study of QX1206 in T2DM Patients With NAFLD
A Phase 1 study testing QX1206 in people with Type 2 Diabetes Mellitus (T2DM) and Non-Alcoholic Fatty Liver Disease (NAFLD), run by 1Globe Health Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Non-Alcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- QX1206
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jan 2025to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centricity Research Toronto LMC.
Toronto
Clinical Research Coordinator, 416-645-2929, Ext 9232, arlene.vinas@centricityresearch.com
About this study
Official title: 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.
- Being tested
- QX1206
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QX1206Drug
QX1206 will be administered orally before bedtime
| Study group | Role | What they receive |
|---|---|---|
| QX1206 | Experimental | Not described Receives: Drug: QX1206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (RP2D)
Measured: Baseline Day 1 up to Week 12
Secondary outcomes (4)
Hemoglobin A1c (HbA1c)
Change in HbA1c percentage from baseline with QX1206
Measured: 12 Weeks
Fasting plasma glucose (FPG)
Change in FPG mg/dL from baseline with QX1206
Measured: 12 Weeks
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Change in the HOMA-IR from baseline with QX1206
Measured: 12 Weeks
Fasting insulin
Change in fasting insulin pmol/L from baseline with QX1206
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start6 Jan 2025
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 1Globe Health Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Keates, PhD, Study director, 1Globe Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694935
- Sponsor's protocol ID
- T2DM-QX1206-1
- Status last verified
- Jan 2025
- First submitted
- 4 Nov 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of QX1206 in Type 2 Diabetes Mellitus (T2DM) Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT06694935
- Acronym / sponsor ID
- T2DM-QX1206-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- 1Globe Health InstituteIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QX1206 | Experimental | Drug: QX1206 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QX1206QX1206 will be administered orally before bedtime | Drug | QX1206 |
Primary outcome
Recommended Phase 2 Dose (RP2D)
Time frame: Baseline Day 1 up to Week 12
4 secondary outcomes
Hemoglobin A1c (HbA1c)
Time frame: 12 Weeks
Fasting plasma glucose (FPG)
Time frame: 12 Weeks
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 12 Weeks
Fasting insulin
Time frame: 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Keates, PhD study director
1Globe Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QX1206 in people with Type 2 Diabetes Mellitus (T2DM) and Non-Alcoholic Fatty Liver Disease (NAFLD), run by 1Globe Health Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact 1Globe Health Institute (617-649-1157, T2DM-QX1206-1_Study@1globe-usa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (RP2D) (time frame: Baseline Day 1 up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.