Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (The SATURN Study).
Summary
This study is a prospective, randomized, double-blind, study of H01 (Hymecromone) in adults with pulmonary hypertension (PH). The primary objective of this study is to evaluate the safety and tolerability of oral H01 and the potential benefit of oral H01 on clinical measures of PH disease severity over 24 weeks. Study Hypothesis: Oral H01, at doses of 1600 mg per day, will be a safe and well-tolerated agent in adults with pulmonary hypertension over 24 weeks
Timeline
- Start
- 2022-04-01
- Primary completion
- 2023-09-21
- Completion
- 2023-09-29
Outcome
Missed primary endpoint
registry analysis (superiority test); Experimental Treatment Oral Hymecromone (H01) vs Placebo; p = 0.541; Mean Difference (Final Values) 0.614 (95% CI -1.47 to 2.79); Mixed Models Analysis NCT05128929 ↗
paper No statistically significant difference in PVR was observed at 24 weeks for the experimental group compared with the placebo group (mean difference 0.61 Wood unit, 95% CI -1.5 to 2.7). PMID 40451287 ↗
Publications
- Czepiel K, Nagy N, Panjalingam T, Kalinowski A, Frymoyer AR, Karmouty-Quintana H, Gu B, Hedlin H, Kaber G, Dobrota Lai S, Rosser JI, Bollyky PL, de Jesus Perez V, Zamanian RT. Randomised, placebo-controlled trial of oral hymecromone in adults with pulmonary hypertension. Thorax. 2025 Aug 15;80(9):632-640. doi: 10.1136/thorax-2024-222725.
- Salman L, Martinez L, Faddoul G, Manning C, Ali K, Salman M, Vazquez-Padron R. Hyaluronan Inhibition as a Therapeutic Target for Diabetic Kidney Disease: What Is Next? Kidney360. 2023 Jun 1;4(6):e851-e860. doi: 10.34067/KID.0000000000000126. Epub 2023 Apr 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hymecromone | Small molecule | 800 mg | Oral |