5 completed, 5 terminated. 6 Phase 2, 4 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 3, Terminated 3 |
| Phase 1 | 4 | Completed 2, Terminated 2 |
| Phase 3 | 1 | Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Healthy Volunteer Study to Compare Fezagepras (PBI-4050) With Sodium Phenylbutyrate Fezagepras, Sodium phenylbutyrate - Hyperammonemia | Phase 1 | Terminated | Liminal BioSciences Ltd. | 8 | 2022-05-13 | 2022-08-01 |
| A Healthy Volunteer Study of PBI-4050 PBI-4050/ Placebo - Fibrosis, Inflammation | Phase 1 | Completed | Liminal BioSciences Ltd. | 65 | 2020-12-09 | 2021-11-30 |
| Single Ascending Dose Study of PBI-4547 in Healthy Subjects PBI-4547, Placebo - Healthy Subjects | Phase 1 | Terminated | Liminal BioSciences Ltd. | 24 | 2019-09-05 | 2020-12-08 |
| Effect of PBI-4050 on the Pharmacokinetics of Midazolam in Heathy Adult Subjects PBI-4050 and midazolam - Healthy | Phase 1 | Completed | Liminal BioSciences Ltd. | 22 | 2018-07-17 | 2020-12-08 |
| Open-Label Rollover Study of PBI 4050 in Subjects With Alström Syndrome PBI-4050 - Alström Syndrome | Phase 2 / Phase 3 | Terminated | Liminal BioSciences Ltd. | 10 | 2017-10-09 | 2020-11-03 |
| Study to Evaluate Safety, Efficacy of PBI-4050 & Its Effect on Relevant Biomarkers in T2DM Patients With Metabolic Syndrome PBI-4050, Placebo - Type 2 Diabetes Mellitus, Metabolic Syndrome | Phase 2 | Terminated | Liminal BioSciences Ltd. | 104 | 2017-05-29 | 2020-12-08 |
| Study of Safety, Tolerability & Efficacy in Cystic Fibrosis Patients With Abnormal Glucose Tolerance PBI4050, Placebo - Cystic Fibrosis | Phase 2 | Terminated | Liminal BioSciences Ltd. | 11 | 2017-01-03 | 2020-12-08 |
| Safety and Tolerability of PBI-4050 and Its Effects on the Biomarkers in Subjects With Alström Syndrome PBI-4050 - Inflammation and Fibrosis, Diabetes | Phase 2 | Completed | Liminal BioSciences Ltd. | 12 | 2016-02-22 | 2018-08-29 |
| A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF) PBI4050 - Idiopathic Pulmonary Fibrosis (IPF) | Phase 2 | Completed | Liminal BioSciences Ltd. | 41 | 2015-07-01 | 2019-04-17 |
| Study to Evaluate the Safety and Tolerability of PBI-4050 in Type 2 Diabetes Patients With Metabolic Syndrome PBI4050 - Type 2 Diabetes, Metabolic Syndrome | Phase 2 | Completed | Liminal BioSciences Ltd. | 24 | 2015-05-01 | 2017-04-11 |
Diabetes Mellitus, Type 2 (2) · Fibrosis (2) · Inflammation (2) · Metabolic Syndrome (2) · Alstrom Syndrome (1) · Cystic Fibrosis (1) · Diabetes Mellitus (1) · Hyperammonemia (1) · Idiopathic Pulmonary Fibrosis (1)
setogepram (9) · 4-phenylbutyric acid (1) · Midazolam (1) · PBI-4547 (1)
Canada (5) · United Kingdom (4) · United States (1)
John Moran, MD (3) · Richard Larouche, MD (1) · Sami Omar (1) · Tarekegn Hiwot, MD (1)