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NCT04332432
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
Phase 1 trial testing belapectin in Hepatic Impairment in 38 participants. Completed in 9 March 2022.
9 March 2022
Quick facts
| Lead sponsor | Galectin Therapeutics Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 16 June 2020 |
| Primary completion | 9 March 2022 |
| Estimated completion | 9 March 2022 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- belapectin — full drug profile →
Conditions studied
- Hepatic Impairment — all drugs for Hepatic Impairment →
Sponsor
Galectin Therapeutics Inc. — full company profile →
Who can join
Adults 18 to 75, any sex, with Hepatic Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Inhibition of galectins in cancer: Biological challenges for their clinical application.
Laderach DJ, Compagno D. · · 2022 · cited 26× · PMID 36703969 · DOI 10.3389/fimmu.2022.1104625 -
Galectins in the Pathogenesis of Common Retinal Disease.
Caridi B, Doncheva D, Sivaprasad S, Turowski P. · · 2021 · cited 6× · PMID 34079467 · DOI 10.3389/fphar.2021.687495 -
Glycobiology-driven therapeutic targeting of glycan-binding proteins: mechanisms, diseases, and clinical translation.
Popatia AM, Sharanek A, Jahani-Asl A. · · 2026 · PMID 42248861 · DOI 10.1038/s41392-026-02768-4
Verify or expand the search:
- PubMed search for NCT04332432
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of belapectin
Trials testing the same drug.
- NCT04365868 — Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis · Phase 2, PHASE3 · terminated
Other recruiting trials for Hepatic Impairment
Currently open trials in the same condition.
- NCT07269301 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function · Phase 1 · recruiting
- NCT07219550 — A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) · Phase 1 · recruiting
- NCT07144111 — A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib · Phase 1 · recruiting
- NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
- NCT06985615 — A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement · Phase 1 · recruiting
Other Galectin Therapeutics Inc. trials
Trials by the same sponsor.
- NCT04365868 — Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis · Phase 2, PHASE3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04332432 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Galectin Therapeutics Inc.
- Last refreshed: 28 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04332432.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing