Clinical Trial Details
| Trial ID: | L0032 |
| Source ID: | NCT04710524 |
| Associated Drug: | FM101 |
| Title: | FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis |
| Acronym: | -- |
| Status: | Recruiting |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Nonalcoholic Fatty Liver Disease|Nonalcoholic Steatohepatitis |
| Interventions: | Drug: Placebo|Drug: FM101 150 mg BID|Drug: FM101 300 mg BID |
| Outcome Measures: | To assess the safety and tolerability of 13 weeks of treatment with FM101 in patients with NAFLD or NASH|To assess the treatment effect of FM101 on serum ALT concentrations during 13 weeks of treatment|To assess the effect of 13 weeks of treatment with FM101 on the change in liver stiffness (kPa) measured by magnetic resonance imaging-magnetic resonance elastography (MRI MRE) in patients with NAFLD or NASH |
| Sponsor/Collaborators: | Future Medicine |
| Gender: | All |
| Age: | 18 Years and older ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 60 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment |
| Start Date: | June 10, 2021 |
| Completion Date: | July 3, 2022 |
| Results First Posted: | -- |
| Last Update Posted: | March 7, 2022 |
| Locations: | Semmelweis Egyetem I. sz. Seb??szeti ??s Intervenci??s Gasztroenterol??giai Klinika, Budapest, Hungary|West Health Kft.,, Budapest, Hungary|Krakowskie Centrum Medyczne sp z o.o., Krak??w, Poland|ID Clinic Arkadiusz Pisula, Mys??owice, Poland|Warsaw IBD Point Profesor Kierkus, Warsaw, Poland|Centrum Medyczne K2J2, Wo??omin, Poland|Centrum Badan Klinicznych Piotr Napora lekarze, Wroc??aw, Poland|Hospital Universitari Vall d Hebron, Barcelona, Spain|Hospital Universitario Marqu??s de Valdecilla, Santander, Spain|Hospital Universitario Virgen del Rocio (HUVR), Sevilla, Spain|Consorcio Hospital General Universitario de Valencia, Valencia, Spain|Hospital Clnico Universitario de Valencia, Valencia, Spain |
| URL: | https://ClinicalTrials.gov/show/NCT04710524 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D477 | FM101 | Chemical drug | -- | A3 adenosine receptor modulator | -- | Under clinical trials | Details |
| D094 | Cysteamine | Chemical drug | DB00847 | GSS stimulant | Renal drug | Under clinical trials | Details |
| D095 | Cysteamine bitartrate | Chemical drug | DB00847 | -- | -- | Under clinical trials | Details |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |