Tier 4 — mechanistic
HTD1801 demonstrates promising potential for histologic improvements in metabolic dysfunction-associated steatohepatitis in both a preclinical and phase 2 study
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
| Design | Companion clinical surrogate analysis with separate animal experiments |
|---|---|
| Model | Human participants; see population |
| Sample | 100 patients from an earlier phase II trial; separate hamster groups |
| Intervention | Secondary noninvasive-marker analysis of HTD1801; hamster histology experiments |
| Duration | 18-week human trial; 6-week animal experiment |
| Endpoints | Glycemic, lipid or liver measures; Dose response; Safety and tolerability |
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