Tier 4 — mechanistic

HTD1801 demonstrates promising potential for histologic improvements in metabolic dysfunction-associated steatohepatitis in both a preclinical and phase 2 study

Wong VW, Neff GW, Di Bisceglie AM, Bai R, Cheng J, Yu M, Liberman A, Liu L, Gunn N
Clinical and molecular hepatology 2025 31(3):1071-1083

Bibliography

PubMed
PMID 40258699
PubMed Central
PMC12260645
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Indexed support: HighTide Therapeutics, Inc.. See the publication for grant details.
Competing interests
The HTD1801 development program includes HighTide-affiliated authors; see the complete individual disclosures.

Study snapshot

DesignCompanion clinical surrogate analysis with separate animal experiments
ModelHuman participants; see population
Sample100 patients from an earlier phase II trial; separate hamster groups
InterventionSecondary noninvasive-marker analysis of HTD1801; hamster histology experiments
Duration18-week human trial; 6-week animal experiment
EndpointsGlycemic, lipid or liver measures; Dose response; Safety and tolerability

What the study showed, in plain terms

The paper combined animal histology with secondary analyses of noninvasive human markers. Human biopsy-confirmed histologic improvement was not demonstrated.

Key findings

  • The paper combined animal histology with secondary analyses of noninvasive human markers. Human biopsy-confirmed histologic improvement was not demonstrated.

What this study can and cannot tell us

Shared clinical cohort with PMID 34535644. Surrogate thresholds and animal tissue findings must not be relabeled as proven human fibrosis reversal.

Citation network

Articles citing this research paper

1 article

Biohack Blueprint analyses that reference this study in their evidence base.

Editorial review

Reviewed by the Biohack Blueprint research team

Last verified