GT-032 Belapectin Hepatic Impairment

NCT04332432 | Completed Phase 1 Results FDA Drug

• 1 other identifier: GT-032
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hepatic Impairment

Keywords

hepatic impairment; GR-MD-02

Outcome Measures

Primary Outcomes (4)

• 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.

  Blood PK: Day -1 to 336 hours post dose

• 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.

  Blood PK: Day -1 to 336 hours post dose

• 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

  Blood PK: Day -1 to 336 hours post dose

• 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.

  Blood PK: Day -1 to 336 hours post dose

Secondary Outcomes (2)

• Summary of Treatment-emergent Adverse Events

  6 weeks

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

  2-120 hours post dose

Study Arms (4)

Group 1

ACTIVE COMPARATOR

16 matched healthy subjects with normal hepatic function

Drug: belapectin

Group 2

ACTIVE COMPARATOR

8 subjects with mild hepatic impairment (Child-Pugh Class A \[4 x subjects with a score of 5 and 4 x subjects with a score of 6\])

Drug: belapectin

Group 3

ACTIVE COMPARATOR

8 subjects with moderate hepatic impairment (Child-Pugh Class B \[score of 7 to 9\])

Drug: belapectin

Group 4

ACTIVE COMPARATOR

8 subjects with severe hepatic impairment (Child-Pugh Class C \[score of 10 to 14\]).

Drug: belapectin

Interventions

belapectin DRUG

intravenous

Also known as: galactoarabino-rhamnogalacturonate, GR-MD-02

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Galectin Therapeutics Inc.: lead

Study Sites (4)

Inland Empire Clinical Trials

Rialto, California, 92377, United States

Location

Clinical Pharmacology of Miami, Inc

Miami, Florida, 33014-3616, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Pinnacle Clinical Research

San Antonio, Texas, 78229, United States

Location

Related Links

• AASLD 2021 Poster #1928 Title: Pharmacokinetic exposure and safety of belapectin, a candidate treatment for NASH-cirrhosis, in patients with hepatic insufficiency

MeSH Terms

Interventions

belapectin

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Galectin Therapeutics

inquiries@galectintherapeutics.com

678-620-3186

Study Officials

• Khurram Jamil, M.D.

  Galectin Therapeutics Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: April 2, 2020
• Study Start: June 16, 2020
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: July 14, 2026
• Results First Posted: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)