Non-alcoholic Steatohepatitis (NASH)Phase 1/2NCT04607655
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GB1211 in Participants With Suspected or Confirmed Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
A Phase 1/2 study testing GB1211 in people with Non-alcoholic Steatohepatitis (NASH), run by Galecto Biotech AB.
Trial summary
This study is a randomised, double-blind, placebo controlled, phase Ib trial in subjects with suspected or confirmed non-alcoholic steatohepatitis (NASH) and liver fibrosis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis (NASH)
- What is being tested?
- GB1211
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Jul 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Males or females, of any race, ≥ 18 and ≤ 75 years of age at enrolment. 2. Body mass index (BMI) of ≥ 25.0 and ≤45.0 kg/m2 3. Diagnosis of suspected NASH and liver fibrosis (Chalasani et al. 2012):
- Evidence of hepatic steatosis within the 24 weeks prior to Screening: i. magnetic resonance imaging (MRI PDFF) suggesting liver fat ≥ 8% or ii. ultrasound (US) indicating fatty liver or iii. FibroScan Controlled Attenuation Parameter (CAP) > 270 dB/m. iv. in participants without a documented history of fatty liver, a FibroScan CAP or US can be performed at Screening. Participants with FibroScan CAP > 270 dB/m or US indicating fatty liver are eligible AND b. Metabolic risk factors: i. Metabolic syndrome (Adult Treatment Panel III definition) requires three or more of the following five disorders (Grundy et al. 2005):
- elevated waist circumference (≥102 cm in men and ≥88 cm in women),
- hypertriglyceridemia (≥1.7 mmol/l),
- low HDL cholesterol level (<1.03 mmol/l in men and <1.3 mmol/l in women),
- high blood pressure (systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg and/or pharmacological treatment)
- elevated fasting glucose (≥5.6 mmol/l and/or pharmacological treatment) ii. OR T2DM (defined as stable diabetes with glycosylated haemoglobin [HbA1c] ≤ 9.5%) OR A diagnosis of confirmed NASH and liver fibrosis based on a biopsy within 12-months of Screening
- 4. Liver stiffness as measured by transient elastography (FibroScan) ≥ 8.5 KPa 5. Women of non-childbearing potential defined as permanently sterile (see Appendix 4) or postmenopausal (see Appendix 4) or Women considered to be of childbearing potential who agree to use highly effective birth control methods until 90 days after the Follow-up visit (see Appendix 4) 6. Males will agree to use contraception throughout the study and until 90-days after the Follow-up visit 7. Male participants must agree to refrain from sperm donation and females should refrain from ova donation from the date of Randomisation (Day -1) until 90 days after the Follow up visit 8. Able to comprehend and willing to sign an ICF and to abide by the study restrictions
Who cannot join
- Any other causes for secondary hepatic fat accumulation such as significant alcohol consumption, use of steatogenic medication or hereditary disorders
- The following clinical laboratory results at Screening:
- ALT > 200 U/L
- AST > 200 U/L
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed)
- Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Randomisation
Show all 15Show fewer
- Positive hepatitis panel and/or positive HIV test
- Evidence of acute Hepatitis A virus (HAV) and a positive serological test for anti-HAV IgM antibodies
- Estimated glomerular filtration rate (eGFR) < 60 mL/[min*1.73 m²] at Screening
- Use or intend to use slow release medications/products considered to still be active within 14 days prior to Randomisation, unless deemed acceptable by the Investigator (or Designee)
- Participant taking any antidiabetic medications, with the exception of metformin and sulfonylureas within 3 months prior to Screening
- Have previously completed or withdrawn from this study investigating GB1211 and have previously received the investigational product
- Participant who, in the opinion of the Investigator (or Designee), should not participate in this study
- Vulnerable/institutionalised patients
- Patients related to PI/site staff
About this study
Official title: GULLIVER-1 - A Randomised, Double-Blind, Placebo Controlled, Phase Ib, 12-week Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GB1211 in Participants With Suspected or Confirmed Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
This study is a randomised, double-blind, placebo controlled, phase Ib trial in subjects with suspected or confirmed non-alcoholic steatohepatitis (NASH) and liver fibrosis
Read the detailed description
This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GB1211 a gelectin-3 inhibitor over 12 weeks. Participants will receive two doses of GB1211, each given twice per day and compared to placebo in participants with fibrotic NASH
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Being tested
- GB1211, Placebo
- Keywords
- GB1211, Non-alcoholic Steatohepatitis, NASH, Liver Fibrosis, Galectin-3 Inhibitor
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB1211Drug
GB1211 is a galectin-3 inhibitor an orally available small molecule anti-fibrotic. It is administered orally twice a day.
PlaceboDrug
Placebo is administered as inhalation once a day
| Study group | Role | What they receive |
|---|---|---|
| Oral GB1211, 100 mg, twice a day | Experimental | GB1211 is a galectin-3 inhibitor an orally available small molecule anti-fibrotic. It is administered orally twice a day. Receives: Drug: GB1211 |
| Oral GB1211, 10 mg, twice a day | Experimental | GB1211 is a galectin-3 inhibitor an orally available small molecule anti-fibrotic. It is administered orally twice a day. Receives: Drug: GB1211 |
| Oral GB1211, Placebo, twice a day | Placebo comparator | Placebo is administered as inhalation once a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of GB1211
Incidence and severity of adverse events as reported by investigators
Measured: 12 Weeks
Safety and Tolerability of GB1211
Incidence of laboratory abnormalities as measured by haematology, clinical chemistry and urinalysis
Measured: 12 Weeks
Safety and Tolerability of GB1211
Physical examination abnormalities measured by vital signs and 12 lead ECG
Measured: 12 Weeks
Secondary outcomes (8)
Pharmacokinetics of GB1211
AUC over a dosing interval (AUC0-τ)
Measured: 12 Weeks
Pharmacokinetics of GB1211
Cmax
Measured: 12 Weeks
Pharmacokinetics of GB1211
Tmax
Measured: 12 Weeks
Pharmacokinetics of GB1211
t1/2
Measured: 12 Weeks
Pharmacokinetics of GB1211
Minimum observed plasma concentration (Cmin)
Measured: 12 Weeks
Pharmacokinetics of GB1211
Observed accumulation ratio based on AUC0-τ (RAAUC0-τ)
Measured: 12 Weeks
Pharmacokinetics of GB1211
Observed accumulation ratio based on Cmax (RACmax)
Measured: 12 Weeks
Pharmacokinetics of GB1211
Volume of distribution and rate of elimination
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 posted29 Oct 2020
- Study startMar 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: Due to COVID-19 pandemic and change in the clinical development strategy for the GB1211 compound
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Steatohepatitis (NASH)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All subjects eligible for the study will be randomised into one of the three treatment arms: A. GB1211 100 mg twice a day B. GB1211 10 mg twice a day C. Placebo twice a day
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galecto Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Michael Charlton, MD, Principal investigator, The University of Chicago Biological Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607655
- Sponsor's protocol ID
- GULLIVER-1
- Other IDs
- 2020-000687-34
- Status last verified
- Oct 2020
- First submitted
- 19 Oct 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GULLIVER-1 - A Randomised, Double-Blind, Placebo Controlled, Phase Ib, 12-week Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GB1211 in Participants With Suspected or Confirmed Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
- ClinicalTrials.gov ID
- NCT04607655
- Acronym / sponsor ID
- GULLIVER-1
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Keywords
- GB1211, Non-alcoholic Steatohepatitis, NASH, Liver Fibrosis, Galectin-3 Inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19 pandemic and change in the clinical development strategy for the GB1211 compound
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Galecto Biotech ABIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 29 Oct 2020 (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 study is a randomised, double-blind, placebo controlled, phase Ib trial in subjects with suspected or confirmed non-alcoholic steatohepatitis (NASH) and liver fibrosis
Detailed description
This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GB1211 a gelectin-3 inhibitor over 12 weeks. Participants will receive two doses of GB1211, each given twice per day and compared to placebo in participants with fibrotic NASH
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- All subjects eligible for the study will be randomised into one of the three treatment arms: A. GB1211 100 mg twice a day B. GB1211 10 mg twice a day C. Placebo twice a day
| Arm | Type | Receives |
|---|---|---|
| Oral GB1211, 100 mg, twice a day | Experimental | Drug: GB1211GB1211 is a galectin-3 inhibitor an orally available small molecule anti-fibrotic. It is administered orally twice a day. |
| Oral GB1211, 10 mg, twice a day | Experimental | Drug: GB1211GB1211 is a galectin-3 inhibitor an orally available small molecule anti-fibrotic. It is administered orally twice a day. |
| Oral GB1211, Placebo, twice a day | Placebo comparator | Drug: PlaceboPlacebo is administered as inhalation once a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Males or females, of any race, ≥ 18 and ≤ 75 years of age at enrolment. 2. Body mass index (BMI) of ≥ 25.0 and ≤45.0 kg/m2 3. Diagnosis of suspected NASH and liver fibrosis (Chalasani et al. 2012):
- Evidence of hepatic steatosis within the 24 weeks prior to Screening: i. magnetic resonance imaging (MRI PDFF) suggesting liver fat ≥ 8% or ii. ultrasound (US) indicating fatty liver or iii. FibroScan Controlled Attenuation Parameter (CAP) > 270 dB/m. iv. in participants without a documented history of fatty liver, a FibroScan CAP or US can be performed at Screening. Participants with FibroScan CAP > 270 dB/m or US indicating fatty liver are eligible AND b. Metabolic risk factors: i. Metabolic syndrome (Adult Treatment Panel III definition) requires three or more of the following five disorders (Grundy et al. 2005):
- elevated waist circumference (≥102 cm in men and ≥88 cm in women),
- hypertriglyceridemia (≥1.7 mmol/l),
- low HDL cholesterol level (<1.03 mmol/l in men and <1.3 mmol/l in women),
Key exclusion criteria (15 listed)
- Any other causes for secondary hepatic fat accumulation such as significant alcohol consumption, use of steatogenic medication or hereditary disorders
- The following clinical laboratory results at Screening:
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed)
- Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Randomisation
- Positive hepatitis panel and/or positive HIV test
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 |
|---|---|---|
| GB1211GB1211 is a galectin-3 inhibitor an orally available small molecule anti-fibrotic. It is administered orally twice a day. | Drug | Oral GB1211, 10 mg, twice a day, Oral GB1211, 100 mg, twice a day |
| PlaceboPlacebo is administered as inhalation once a day | Drug | Oral GB1211, Placebo, twice a day |
Primary outcome
Safety and Tolerability of GB1211
Time frame: 12 Weeks
Incidence and severity of adverse events as reported by investigators
Safety and Tolerability of GB1211
Time frame: 12 Weeks
Incidence of laboratory abnormalities as measured by haematology, clinical chemistry and urinalysis
Safety and Tolerability of GB1211
Time frame: 12 Weeks
Physical examination abnormalities measured by vital signs and 12 lead ECG
8 secondary outcomes
Pharmacokinetics of GB1211
Time frame: 12 Weeks
Pharmacokinetics of GB1211
Time frame: 12 Weeks
Pharmacokinetics of GB1211
Time frame: 12 Weeks
Pharmacokinetics of GB1211
Time frame: 12 Weeks
Pharmacokinetics of GB1211
Time frame: 12 Weeks
Pharmacokinetics of GB1211
Time frame: 12 Weeks
Pharmacokinetics of GB1211
Time frame: 12 Weeks
Pharmacokinetics of GB1211
Time frame: 12 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michael Charlton, MD principal investigator
The University of Chicago Biological Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GB1211 in people with Non-alcoholic Steatohepatitis (NASH), run by Galecto Biotech AB.
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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of GB1211 (time frame: 12 Weeks). The study lists 3 primary outcomes in all. 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 4 Feb 2021.