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Hepatic ImpairmentPhase 1NCT04332432

GT-032 Belapectin Hepatic Impairment

A Phase 1 study testing belapectin in people with Hepatic Impairment, run by Galectin Therapeutics Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will assess the pharmacokinetics of belapectin in subjects with mild, moderate, or severe hepatic impairment according to 3 different Child-Pugh categories: mild, moderate, or severe impairment, compared to matched healthy control subjects. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Hepatic Impairment
What is being tested?
belapectin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
4 sitesUnited States
Study dates
16 Jun 2020to 9 Mar 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All Subjects
  • Males or females, of any race, between 18 and 75 years of age, inclusive.
  • Body mass index between 18.0 and 45.0 kg/m2, inclusive.
  • Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at Screening and Check-in. Females of childbearing potential must agree to use contraception by a method of proven reliability (including abstinence) for the duration of the study.
  • Males will agree to use contraception.
  • Male subjects must not donate sperm from Check-in (Day -1) until 90 days after the Follow-up visit.
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  • Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
  • Subjects with Normal Hepatic Function Only
  • In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at Screening and Check in (Day -1), as assessed by the Investigator (or designee).
  • Matched to subjects with mild, moderate, or severe hepatic impairment in sex, age (±10 years), and body mass index (BMI) (±20%).
  • Subjects with Hepatic Impairment Only
  • Documented chronic stable liver disease based on Child-Pugh score and classification (Child-Pugh Class A [mild], B [moderate], or C [severe]; at Screening and Check-in (if the classification differs when assessed at Check-in compared to Screening, enrollment of the subject into a hepatic category will be based on the score at Screening):
  • 'Documented' is defined by at least 1 of the following: medical history, physical examination, hepatic ultrasound, computed axial tomography scan, magnetic resonance imaging, and/or liver biopsy.
  • 'Chronic' is defined as >6 months.
  • 'Stable' is defined as no clinically significant change in disease status within the last 1 month (30 days), as documented by the subject's recent medical history (eg, no worsening of clinical signs of hepatic impairment, or no worsening of total bilirubin or prothrombin time, at the discretion of the Investigator [or designee] or Medical Monitor).
  • Subjects with mild, moderate, or severe hepatic impairment may have medical findings consistent with their hepatic dysfunction as determined by medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Check-in (Day -1), as assessed by the Investigator (or designee).
  • Non-hepatic, abnormal clinical laboratory evaluations must not be clinically relevant, as judged by the Investigator (or designee) and Medical Monitor.
  • Currently on a stable medication regimen, defined as not starting new drug(s) or changing drug dose(s) within 30 days of administration of study drug (Day 1). Concomitant medications administered within 30 days prior to administration of study drug (Day 1) must be approved by the Investigator (or designee), Sponsor, and Medical Monitor.
  • Anemia secondary to hepatic disease will be acceptable, if hemoglobin is > 9 g/dL and anemia symptoms are not clinically significant as judged by the Investigator (or designee) and Medical Monitor.
  • Subjects must have a platelet count ≥35 × 10^9 platelets/L.

Who cannot join

  • All Subjects
  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
  • Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
  • Alcohol consumption of > 21 drinks per week for males and > 14 drinks for females.
  • Positive urine drug screen at Screening and/or Check in (Day -1), that is not otherwise explained by permitted concomitant medication or ingestion of poppy seeds, or positive alcohol test result (breath or urine in accordance with standard practice at each CRU) at Screening or Check-in (Day -1).
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  • Positive human immunodeficiency virus test.
  • Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days, or 5 half-lives (whichever is longer), prior to dosing.
  • Ingestion of Seville orange or grapefruit containing foods or beverages within 7 days prior to Check-in (Day -1).
  • Receipt of blood products within 2 months prior to Check in (Day -1).
  • Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
  • Poor peripheral venous access.
  • Have previously completed or withdrawn from this study or any other study investigating belapectin, and have previously received belapectin.
  • Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
  • Subjects with Normal Hepatic Function Only
  • History of alcoholism or drug/chemical abuse within 2 years prior to Check in.
  • Subject has creatinine clearance <90 mL/minute as calculated by using the Cockcroft Gault equation:
  • [1.23 × (140 - age) × (weight in kg)] ÷ (serum creatinine in μmol/L) - if male.
  • [1.04 × (140 - age) × (weight in kg)] ÷ (serum creatinine in μmol/L) - if female.
  • Confirmed supine blood pressure > 140 mmHg or < 90 mmHg and/or supine diastolic blood pressure > 90 mmHg or < 50 mmHg, or resting (supine) heart rate < 45 bpm or > 100 bpm at Screening or Check-in (Day -1), with a QT interval corrected for heart rate using Fridericia's method (QTcF) > 450 ms for male subjects and > 470 ms for female subjects.
  • Use or intend to use any prescription medications/products other than prescribed hormone replacement therapy or contraception within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
  • Use or intend to use slow release medications/products considered to still be active within 14 days prior to Check in (Day -1), unless deemed acceptable by the Investigator (or designee).
  • Use or intend to use any nonprescription medications/products including vitamins and minerals within 7 days prior to Check in (Day -1), unless deemed acceptable by the Investigator (or designee).
  • Positive serology test results for hepatitis A, hepatitis B antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies.
  • Clinically significant abnormal laboratory values (clinical chemistry, hematology, coagulation, and urinalysis), as determined by the Investigator (or designee).
  • Significant history or clinical manifestation of hepatic disorder, as determined by the Investigator (or designee).
  • History or presence of liver disease or liver injury as indicated by any clinically significant deviations from normal reference ranges in liver function tests, unless approved by the Investigator (or designee).
  • Use of tobacco- or nicotine-containing products within 3 months prior to Check in (Day -1), or positive cotinine test at Screening or Check-in.
  • Subjects with Hepatic Impairment Only
  • Cirrhosis etiology of primary biliary cholangitis or primary sclerosing cholangitis.
  • History of alcoholism or drug/chemical abuse within 6 months prior to Check in.
  • Evidence of hepatorenal syndrome and/or creatinine clearance < 45 mL/min, as calculated using the Cockcroft-Gault equation:
  • [1.23 × (140 - age) × (weight in kg)] ÷ (serum creatinine in μmol/L) - if male.
  • [1.04 × (140 - age) × (weight in kg)] ÷ (serum creatinine in μmol/L) - if female.
  • Confirmed supine blood pressure > 150 mmHg or < 90 mmHg and/or supine diastolic blood pressure > 90 mmHg or < 50 mmHg, or resting (supine) heart rate < 45 bpm or > 100 bpm at Screening or Check-in (Day -1), with a QTcF > 480 ms for male and female subjects.
  • Use or intend to use any prescription medications/products within 14 days of study drug administration, with the exception of:
  • stable medication regimen, as approved by the Investigator (or designee), Sponsor, and Medical Monitor; see inclusion criterion 12
  • prescribed hormone replacement therapy
  • prescribed contraceptive.
  • Values outside the normal range for liver function tests that are not consistent with their hepatic condition, as determined by the Investigator (or designee).
  • Positive serology test results for hepatitis A, hepatitis B DNA (hepatitis B DNA levels will be analyzed if subject tests positive for HBsAg or hepatitis B core antibodies), or hepatitis C RNA (hepatitis C RNA levels will be analyzed if subject tests positive for hepatitis C antibodies).
  • Clinically significant abnormal physical examination, vital signs, and/or ECG findings that are not consistent with their degree of hepatic dysfunction, as determined by the Investigator (or designee).
  • Recent history, or the treatment of, esophageal bleeding (within the 180 days prior to Screening), unless banded.
  • History of hepatic shunt surgery or presence of a portosystemic shunt.
  • History of paracentesis within 7 days prior to screening. Paracentesis will not be permitted throughout the study.
  • Current functioning organ transplant or likely to be transplanted within the next two months.
  • Evidence of severe ascites needing paracentesis/not controlled by medication.
  • Current symptoms or recent history of hepatic encephalopathy (Grade 2 or above) at Screening.
  • Smoke more than 10 cigarettes, or use the equivalent tobacco or nicotine containing products (including vaping), per day or inability to refrain from tobacco/nicotine use 2 hours predose until 4 hours postdose.
  • Unstable diabetes as evidenced by hemoglobin A1c > 9%.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Clinical Pharmacology of Miami, Inc

    Miami, Florida, 33014-3616

  • Inland Empire Clinical Trials

    Rialto, California, 92377

  • Texas Liver Institute

    San Antonio, Texas, 78215

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Single-dose, Open-label, Pharmacokinetic Study of Belapectin (GR-MD-02) in Subjects With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment

This study will assess the pharmacokinetics of belapectin in subjects with mild, moderate, or severe hepatic impairment according to 3 different Child-Pugh categories: mild, moderate, or severe impairment, compared to matched healthy control subjects.

Read the detailed description

This was a Phase 1, open-label, non-randomized, parallel-group study to determine the effect of hepatic impairment on the PK, safety, and tolerability of a single IV dose of belapectin compared to matched healthy subjects with normal hepatic function.

Being tested
belapectin
Keywords
hepatic impairment, GR-MD-02

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • belapectinDrug

    Also called galactoarabino-rhamnogalacturonate, GR-MD-02

    intravenous

Study groups in NCT04332432
Study groupRoleWhat they receive
Group 1Active comparator16 matched healthy subjects with normal hepatic function
Receives: Drug: belapectin
Group 2Active comparator8 subjects with mild hepatic impairment (Child-Pugh Class A [4 x subjects with a score of 5 and 4 x subjects with a score of 6])
Receives: Drug: belapectin
Group 3Active comparator8 subjects with moderate hepatic impairment (Child-Pugh Class B [score of 7 to 9])
Receives: Drug: belapectin
Group 4Active comparator8 subjects with severe hepatic impairment (Child-Pugh Class C [score of 10 to 14]).
Receives: Drug: belapectin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To Assess the PK AUC0-∞ of Belapectin Following a Single IV Dose of Belapectin in Subjects With Mild, Moderate, or Severe Hepatic Impairment, Compared to Healthy Subjects With Normal Hepatic Function.

    Statistical comparison of the pharmacokinetic AUC0-∞ parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose . AUC0-∞ = area under the concentration-time curve from time 0 to infinity.

    Measured: Blood PK: Day -1 to 336 hours post dose

  2. To Assess the PK AUC0-t of Belapectin Following a Single IV Dose of Belapectin in Subjects With Mild, Moderate, or Severe Hepatic Impairment, Compared to Healthy Subjects With Normal Hepatic Function.

    Statistical comparison of the pharmacokinetic AUC0-t parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose. AUC0-t = area under the concentration-time curve from time 0 to the last measurable concentration.

    Measured: Blood PK: Day -1 to 336 hours post dose

  3. To Assess the PK Cmax of Belapectin Following a Single IV Dose of Belapectin in Subjects With Mild, Moderate, or Severe Hepatic Impairment, Compared to Healthy Subjects With Normal Hepatic Function.

    Statistical comparison of the pharmacokinetic Cmax parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose. Cmax = maximum observed concentration

    Measured: Blood PK: Day -1 to 336 hours post dose

  4. To Assess the PK t1/2 of Belapectin Following a Single IV Dose of Belapectin in Subjects With Mild, Moderate, or Severe Hepatic Impairment, Compared to Healthy Subjects With Normal Hepatic Function.

    Statistical comparison of the pharmacokinetic t1/2 parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose. t1/2 = terminal elimination half-life.

    Measured: Blood PK: Day -1 to 336 hours post dose

Secondary outcomes (2)

  1. Summary of Treatment-emergent Adverse Events

    To evaluate the safety and tolerability of a single IV dose of belapectin in subjects with mild, moderate, or severe hepatic impairment, and in healthy subjects with normal hepatic function.

    Measured: 6 weeks

  2. Fraction Percentage of Belapectin Dose Excreted in the Urine Over the Time Interval t1 to t2 (fet1-t2)

    Cumulative amount of belapectin excreted in urine over the specified timeframe, expressed as percentage of the administered dose (fet1-t2).

    Measured: 2-120 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2020
  2. Study start16 Jun 2020
  3. Primary completion9 Mar 2022
  4. Study completion9 Mar 2022

Resources

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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04332432
Sponsor's protocol ID
GT-032
Status last verified
Jun 2026
First submitted
24 Mar 2020
Last updated
14 Jul 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing belapectin in people with Hepatic Impairment, run by Galectin Therapeutics Inc. at 4 sites in United States.

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 20 inclusion and 50 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: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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?

Yes. Results are posted in the registry (first posted 14 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

To Assess the PK AUC0-∞ of Belapectin Following a Single IV Dose of Belapectin in Subjects With Mild, Moderate, or Severe Hepatic Impairment, Compared to Healthy Subjects With Normal Hepatic Function. (time frame: Blood PK: Day -1 to 336 hours post dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04332432.

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 14 Jul 2026.

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GT-032 Belapectin Hepatic Impairment (NCT04332432) | AzTrials