Asset profile
ARO-HSD
Unknown / undisclosed
Evidence outlook · no controlled comparison
NCT04202354 · Non-alcoholic Steatohepatitis
The lead study is single-arm or otherwise uncontrolled, so it produced no formal comparison against a control. This tier describes the design, not an outcome.
NCT04202354: This is a small early-phase dose-escalation study: only the healthy-volunteer cohorts were randomized, quadruple-blinded, and placebo-controlled (4 participants per ARO-HSD dose vs 16 pooled placebo), while the suspected-NASH cohorts were open-label with no comparator (6 per dose). The primary endpoint was a safety endpoint — the number of treatment-related adverse events — reported as descriptive counts with no statistical analysis, and the secondary endpoints were pharmacokinetic measurements. With a total of 50 participants and no efficacy endpoint (no histology, imaging, or clinical outcome in NASH), the trial is far too small and early-phase to provide evidence of clinical benefit.
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Competitive landscape
30 competitors in this universe: 1 direct rival (same mechanism and indication), 0 same-class, 29 same-indication; 24 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| ARO-HSD: this drug | Phase 1/2 | — | HSD17B13 (hydroxysteroid 17-beta dehydrogenase 13) mRNA | ||
| AZD7503 | Phase 1 | — | HSD17B13 (hydroxysteroid 17-beta dehydrogenase 13) mRNA | ||
| Resmetirom (Rezdiffra) | Approved | Small molecule | Thyroid hormone receptor-beta | ||
| Rosuvastatin | Approved | Small molecule | HMG-CoA reductase | ||
| Semaglutide (Wegovy / Ozempic / Rybelsus) | Approved | Peptide | GLP-1 receptor | ||
| ALN-CIDEB | Phase 3 | RNA / oligonucleotide | CIDEB | ||
| Denifanstat | Phase 3 | Small molecule | Fatty acid synthase (FASN), FASN | ||
| Efimosfermin | Phase 3 | Protein / enzyme therapeutic | FGF21 | ||
| Efimosfermin Alfa | Phase 3 | Protein / enzyme therapeutic | FGF21 receptor | ||
| Lobeglitazone (Duvie) | Phase 3 | Small molecule | PPAR-gamma | ||
| Namodenoson | Phase 3 | — | Adenosine A3 receptor | ||
| Pemvidutide | Phase 3 | Peptide | GLP-1/glucagon receptor (dual) | ||
| Survodutide | Phase 3 | Peptide | GLP-1/glucagon receptor (dual) | ||
| Belapectin | Phase 2/3 | Protein / enzyme therapeutic | Galectin-3 | ||
| GR-MD-02 | Phase 2/3 | Protein / enzyme therapeutic | Galectin-3 | ||
| ALN-HSD | Phase 2 | RNA / oligonucleotide | HSD17B13 |
…and 15 more. Research shows the complete landscape.
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All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.