| Trial ID: | L0132 |
| Source ID: | NCT02330549
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| Associated Drug: |
Cenicriviroc
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| Title: |
ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) and Suspected NAFLD
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| Acronym: |
--
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| Status: |
Completed
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| Study Results: |
Has Results
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| Results: |
https://ClinicalTrials.gov/show/NCT02330549/results
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| Conditions: |
Prediabetic State|Non-alcoholic Fatty Liver Disease|Type 2 Diabetes Mellitus
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| Interventions: |
Drug: Cenicriviroc 150 mg|Drug: Placebo
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| Outcome Measures: |
Change From Baseline in Matsuda Index|Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR ) Index|Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue|Change From Baseline in C-C Chemokine Receptor Type 2 (CCR2) and C-C Chemokine Receptor Type 5 (CCR5) in Subcutaneous Adipose Tissue|Change From Baseline in Peripheral Monocyte Subsets (CD14/CD16)|Change From Baseline in Fasting Plasma Glucose (FPG)|Change From Baseline in Fasting Plasma Insulin (FPI)|Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI)|Change From Baseline in Homeostasis Model of Insulin Resistance (HOMA-IR)|Change From Baseline in Homeostasis Model Assessment of ??-cell Function (HOMA-%B)|Change From Baseline in Fasting Glycosylated Hemoglobin A1c (HbA1c)|Change From Baseline in Plasma Glucagon Concentration|Plasma Glucose at 30, 60, 90 and 120 Minutes Following Glucose Load|Plasma Insulin at 30, 60, 90 and 120 Minutes Following Glucose Load|Change From Baseline in Area Under the Concentration-time Curve From Time 0 to 120 Minutes [AUC (0-120 Min)] for Serum Glucose|Change From Baseline in Area Under the Concentration-time Curve From Time 30 to 120 Minutes [AUC (30-120 Min)] for Serum Glucose|Change From Baseline in AUC (0-120 Min) for Plasma Insulin|Change From Baseline in AUC (30-120 Min) for Plasma Insulin|Change From Baseline in Fasting Free Fatty Acids|Change From Baseline in Serum Adiponectin Concentration|Change From Baseline in Serum Resistin Concentration|Serum FFA at 30, 60, 90 and 120 Minutes Following Glucose Load|Change From Baseline in AUC (0-120 Min) for Serum FFA|Change From Baseline in AUC (30-120 Min) for Serum FFA|Change From Baseline in the Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)|Number of Participants by NASH Clinical Research Network (CRN) Staging Categories|Change From Baseline in Serum C-C Chemokine Receptor Type 2 (CCR2) Ligand: Monocyte Chemotactic Protein 1 (MCP-1)|Change From Baseline in Serum C-C Chemokine Receptor Type 5 (CCR5) Ligand: RANTES|Change From Baseline in Serum CCR5 Ligand: Macrophage Inflammatory Protein 1 Alpha (MIP-1??)|Change From Baseline in Serum CCR5 Ligand: Macrophage Inflammatory Protein 1 Beta (MIP-1??)|Change From Baseline in Biomarker of Inflammation: Interleukin 1 Beta (IL-1??)|Change From Baseline in Biomarker of Inflammation: Interleukin 6 (IL-6)|Change From Baseline in Biomarker of Inflammation: Interleukin 8 (IL-8)|Change From Baseline in Biomarker of Inflammation: Interleukin 10 (IL-10)|Change From Baseline in Biomarker of Inflammation: High Sensitivity C Reactive Protein (Hs-CRP)|Change From Baseline in Biomarker of Inflammation: Tumor Necrosis Factor Alpha (TNF-??)|Change From Baseline in Noninvasive Metabolic Biomarker: Hyaluronic Acid|Change From Baseline in Noninvasive Metabolic Biomarker: Cytokeratin-18 (CK-18) [M30 and M65]|Change From Baseline in Noninvasive Metabolic Biomarker: Fibroblast Growth Factor-21 (FGF-21)|Change From Baseline in Noninvasive Metabolic Biomarker: Mac-2 Binding Protein (Mac-2BP)|Change From Baseline in Noninvasive Metabolic Serum Biomarker: Cluster of Differentiation (CD95)|Change From Baseline in Noninvasive Metabolic Marker: Alpha-fetoprotein (AFP)|Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan???) Test: Fat Fraction|Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan???) Test: Corrected T1 (cT1)|Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan???) Test: cT1 Mode Values Within the Liver|Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan???) Test: Liver Inflammation and Fibrosis (LIF) Score|Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan???) Test: Iron Content|Change From Baseline in Body Weight|Change From Baseline in Liver Transaminase: Alanine Aminotransferase (ALT)|Change From Baseline in Liver Transaminase: Aspartate Aminotransferase (AST)|Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)|Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results|Plasma Cenicriviroc Concentrations|Number of Participants With Abnormal Physical Examination Findings
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| Sponsor/Collaborators: |
Tobira Therapeutics, Inc.
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| Gender: |
All
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| Age: |
18 Years to 75 Years ?? (Adult, Older Adult)
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| Phases: |
Phase 2
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| Enrollment: |
45
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| Study Type: |
Interventional
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| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
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| Start Date: |
July 17, 2015
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| Completion Date: |
September 8, 2016
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| Results First Posted: |
October 11, 2019
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| Last Update Posted: |
October 11, 2019
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| Locations: |
San Antonio Military Medical Center, Fort Sam Houston, Texas, United States|Gastroenterology Consultants of San Antonio Digestive Research Center, San Antonio, Texas, United States|Fundacion de Investigacion, San Juan, Puerto Rico
|
| URL: |
https://ClinicalTrials.gov/show/NCT02330549
|
