Clinical Trials Logo

Clinical Trial Summary

BRB-018-001 is a multicenter, adaptive design, randomized, parallel group study to evaluate the safety, tolerability, and PK of repeat IV doses of RYI-018 in subjects with NAFLD.


Clinical Trial Description

BRB-018-001 will be conducted as a multicenter, adaptive design, randomized, parallel group study to evaluate the safety, tolerability, and PK of repeat IV doses of RYI-018 in subjects with NAFLD. Subjects in each cohort shall be randomized to either RYI-018 or placebo as weekly injection for four weeks. The active doses of RYI-018 will be as follows: Cohort 1: 0.6 mg/kg, Cohort 2: 1.2 mg/kg, and Cohort 3: 2.5 mg/kg. Primary endpoints include safety and tolerability. Secondary endpoints include pharmacokinetics and immunogenicity. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03261739
Study type Interventional
Source Bird Rock Bio, Inc.
Contact
Status Completed
Phase Phase 1
Start date August 28, 2017
Completion date August 24, 2018

See also
  Status Clinical Trial Phase
Completed NCT06101433 - The Effect of Soy Isoflavones on Non-alcoholic Fatty Liver Disease and the Level of FGF-21 and Fetuin A N/A
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Active, not recruiting NCT05479721 - LITMUS Imaging Study
Completed NCT05527938 - Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children N/A
Recruiting NCT06308757 - Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis N/A
Completed NCT02654977 - CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy Phase 2
Completed NCT02927184 - Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease Phase 2
Completed NCT06047847 - Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption N/A
Active, not recruiting NCT03534908 - Nonalcoholic Fatty Liver Disease and Cardiovascular Disease: the Correlation Analysis and Risk Prediction Model Study
Recruiting NCT06098417 - Biomarkers in the Diagnosis and Prognosis of NAFLD
Recruiting NCT04564391 - Whey or Casein - Liver Fat Reduction and Metabolic Improvement by Fast vs. Slow Proteins N/A
Not yet recruiting NCT05984745 - Effect of CoQ10 on the Outcome of MAFLD Patients Phase 2
Not yet recruiting NCT05052515 - The Effects of Natural Extracts Supplementation on NASH Patients N/A
Recruiting NCT02459496 - Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus N/A
Completed NCT01936779 - Understanding the Role of Dietary Fatty Acids on Liver Fat Metabolism in Humans N/A
Completed NCT05844137 - Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes N/A
Recruiting NCT04664036 - Prevalence, Incidence and Characteristics of NAFLD/NASH in Type 1 Diabetes Mellitus
Recruiting NCT04976283 - Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver Phase 4
Recruiting NCT03587298 - Use of Shear Wave Elastography to Assess Non-alcoholic Fatty Liver Disease (NAFLD)
Completed NCT02952170 - Impact of Weight Loss Surgery in Adolescents With NAFLD N/A