- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02330549
ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) and Suspected NAFLD
September 17, 2019 updated by: Tobira Therapeutics, Inc.
ORION - Effect of CCR2 and CCR5 Antagonism by Cenicriviroc on Peripheral and Adipose Tissue Insulin Sensitivity in Adult Obese Subjects With Prediabetes or Type 2 Diabetes Mellitus and Suspected Non-Alcoholic Fatty Liver Disease (NAFLD)
A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study of cenicriviroc (CVC) to be conducted in approximately 50 adult obese subjects [body mass index (BMI) ≥ 30 kg/m^2] with prediabetes or type 2 diabetes mellitus and suspected NALFD.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Approximately 50 adult obese subjects (BMI ≥ 30 kg/m2) with prediabetes or type 2 diabetes mellitus and suspected NALFD will be randomized into the study.
Eligible subjects will receive either CVC (n=25) or matching placebo (n=25), once daily (QD) for 24 weeks, followed by a safety follow-up visit 4 weeks after last intake of study medication.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San Juan, Puerto Rico, 00927-4807
- Fundación de Investigación
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Texas
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Fort Sam Houston, Texas, United States, 78234
- San Antonio Military Medical Center
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San Antonio, Texas, United States, 78258
- Gastroenterology Consultants of San Antonio Digestive Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult male and female subjects aged between 18-75 years
- Obesity as defined by BMI ≥ 30 kg/m2
- Evidence of prediabetes or type 2 diabetes mellitus based on Screening laboratory values with at least one of the following criteria:
- Fasting plasma glucose (FPG) of 100 - 270 mg/dL (5.6 - 15.0 mmol/L)
- Hemoglobin A1c (HbA1c) of 5.7 - 10.0%
- Participants receiving metformin alone or in combination with a sulfonylurea (glimepiride, glipizide, glyburide, or gliclazide) must be on stable therapy for at least 90 days prior to Screening.
- Suspected diagnosis of NAFLD warranting confirmation by liver biopsy
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 upper limit normal (ULN)
- Ability to understand and sign a written informed consent form
- Females of child-bearing potential and males participating in the study must agree to use at least 2 approved barrier methods of contraception throughout the duration of the study and for 3 months after stopping study drug. Females who are postmenopausal must have documentation of cessation of menses for ≥ 12 months and serum follicle stimulating hormone (FSH) ≥ 30 mU/mL
- Participants receiving allowed concomitant medications need to be on stable therapy for 28 days prior to Baseline.
Exclusion Criteria:
- Use of oral antihyperglycemic agents (OHAs) other than metformin or sulfonylureas, including but not limited to thiazolidinediones, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, meglitinides, α-glucosidase inhibitors, colesevelam, bromocriptine, pramlintide or basal insulin within 90 days prior to Screening or anticipated use during the trial
- Type 1 diabetes
- Hepatitis B Surface Antigen (HBsAg) positive
- Human Immunodeficiency Virus-1 (HIV-1) or Human Immunodeficiency Virsu-2 (HIV-2) infection
- Hepatitis C Virus Antibody (HCVAb) positive
- Prior or planned liver transplantation
- Other known causes of chronic liver disease, including alcoholic liver disease
- History of cirrhosis and/or hepatic decompensation including ascites, encephalopathy or variceal bleeding
- Alcohol consumption greater than 14 units/week
- Weight reduction through bariatric surgery or planned bariatric surgery during the conduct of the study (including gastric banding)
- Any Grade ≥ 3 laboratory abnormality as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Toxicity Grading Scale, except subjects with Grade ≥ 3 dyslipidemia with triglyceride or cholesterol elevations unless clinical assessment foresees an immediate health risk to the subject
- Serum albumin < 3.5 g/dL
- Serum creatinine levels ≥ 1.5 mg/dL for males or ≥ 1.4 mg/dL for females if participant is receiving metformin
- Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) equation
- Platelet count < 100,000/mm3
- Hemoglobin < 12 g/dL for males or < 11 g/dL for females
- Females who are pregnant or breastfeeding
- Receiving ongoing therapy with any disallowed medication at Screening
- Allergy to the study drug or its components
- Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing and protocol requirements.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cenicriviroc 150 mg
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
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Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food.
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Placebo Comparator: Placebo
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
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Placebo-matching CVC administered orally once daily and taken every morning with food.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Matsuda Index
Time Frame: Baseline (Day 1) to Weeks 12 and 24
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Change in peripheral insulin sensitivity was measured by the Matsuda Index.
Fasting plasma glucose (FPG) and fasting plasma insulin (FPI) concentrations measured during the oral glucose tolerance test (OGTT) were used to calculate the Matsuda Index.
Matsuda Index=10,000/square root [FPG mg/dL x FPI μIU/mL) x (mean glucose mg/dL x mean insulin μIU/mL during OGTT)].
A Matsuda index of <2.5 indicates whole body insulin resistance.
A lower Matsuda Index indicates the worst disease state.
An increase in the Matsuda Index indicates an improvement in insulin sensitivity (best).
A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 12 and 24
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Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR ) Index
Time Frame: Baseline (Day 1) to Weeks 12 and 24
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Change in adipose insulin sensitivity was measured by Adipo-IR.
Adipo-IR= (Fasting Serum free fatty acid (FFA) mmol/L x FPI μIU/mL).
A higher Adipo-IR index indicates the worst disease state.
A lower Adipo-IR Index is best.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 12 and 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue
Time Frame: Baseline (Day 1) to Week 24
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Macrophage infiltration in adipose tissue was assessed in paraffin-embedded adipose punch biopsies by immunohistochemistry stained for cluster of differentiation 68 (CD68), cluster of differentiation 163 (CD163), C-C chemokine receptor type 2 (CCR2), C-C chemokine receptor type 5 (CCR5) and cluster of differentiation 206 (CD206).
A reduction in infiltration indicates less inflammation.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Week 24
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Change From Baseline in C-C Chemokine Receptor Type 2 (CCR2) and C-C Chemokine Receptor Type 5 (CCR5) in Subcutaneous Adipose Tissue
Time Frame: Baseline (Day 1) to Week 24
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CCR2 and CCR5 corresponding ligands' messenger ribonucleic acid (mRNA) gene expression were assessed in frozen adipose tissue by quantitative polymerase chain reaction (PCR).
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Week 24
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Change From Baseline in Peripheral Monocyte Subsets (CD14/CD16)
Time Frame: Baseline (Day 1) to Week 24
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Peripheral monocyte subsets (cluster of differentiation 14 (CD14/cluster of differentiation 16 (CD16)] were measured in fresh peripheral blood mononuclear cells (PBMCs) samples by flow cytometry.
Monocyte results are reported for Total, Classical (CD14+CD16-), Intermediate (CD14+CD16+) and Non-classical (CD14lowCD16+).
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Week 24
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Change From Baseline in Fasting Plasma Glucose (FPG)
Time Frame: Baseline (Day1) to Weeks 12 and 24
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A fasting blood sample was collected and was sent to a central laboratory for analysis of glucose.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day1) to Weeks 12 and 24
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Change From Baseline in Fasting Plasma Insulin (FPI)
Time Frame: Baseline (Day 1) to Weeks 12 and 24
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A fasting blood sample was collected and was sent to a central laboratory for analysis of insulin.
A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 12 and 24
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Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI)
Time Frame: Baseline (Day1) to Weeks 12 and 24
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QUICKI is used to measure insulin sensitivity.
QUICKI = 1/(log FPI μIU/mL + log FPG mg/dL).
A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
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Baseline (Day1) to Weeks 12 and 24
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Change From Baseline in Homeostasis Model of Insulin Resistance (HOMA-IR)
Time Frame: Baseline (Day 1) to Weeks 12 and 24
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HOMA-IR = (FPG mg/dL x FPI μIU/mL)/405.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 12 and 24
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Change From Baseline in Homeostasis Model Assessment of β-cell Function (HOMA-%B)
Time Frame: Baseline (Day 1) to Weeks 12 and 24
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HOMA-%B= (20 × FPI)/(FPG - 3.5).
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 12 and 24
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Change From Baseline in Fasting Glycosylated Hemoglobin A1c (HbA1c)
Time Frame: Baseline (Day 1) to Weeks 12 and 24
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A fasting blood sample was collected and was sent to a central laboratory for analysis of glucose.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 12 and 24
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Change From Baseline in Plasma Glucagon Concentration
Time Frame: Baseline (Day 1) to Weeks 12 and 24
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A fasting blood sample was collected and was sent to a central laboratory for analysis of glucagon.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 12 and 24
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Plasma Glucose at 30, 60, 90 and 120 Minutes Following Glucose Load
Time Frame: Prior to Glucose Load, 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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Blood was collected during the oral glucose tolerance test and was sent to a central laboratory for analysis of glucose.
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Prior to Glucose Load, 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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Plasma Insulin at 30, 60, 90 and 120 Minutes Following Glucose Load
Time Frame: Pre-glucose load, 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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Blood was collected during the oral glucose tolerance test and was sent to a central laboratory for analysis of insulin.
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Pre-glucose load, 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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Change From Baseline in Area Under the Concentration-time Curve From Time 0 to 120 Minutes [AUC (0-120 Min)] for Serum Glucose
Time Frame: Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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AUC(0-120 min) was derived from the serum glucose values obtained during the oral glucose tolerance test.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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Change From Baseline in Area Under the Concentration-time Curve From Time 30 to 120 Minutes [AUC (30-120 Min)] for Serum Glucose
Time Frame: Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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AUC(30-120 min) was derived from the serum glucose values obtained during the oral glucose tolerance test.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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Change From Baseline in AUC (0-120 Min) for Plasma Insulin
Time Frame: Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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AUC(0-120 min) was derived from the plasma insulin values obtained during the oral glucose tolerance test.
A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
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Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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Change From Baseline in AUC (30-120 Min) for Plasma Insulin
Time Frame: Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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AUC(30-120 min) was derived from the plasma insulin values obtained during the oral glucose tolerance test.
A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
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Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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Change From Baseline in Fasting Free Fatty Acids
Time Frame: Baseline (Day 1) to Weeks 12 and 24
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A fasting blood sample was collected and was sent to a central laboratory for analysis of free fatty acids.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 12 and 24
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Change From Baseline in Serum Adiponectin Concentration
Time Frame: Baseline (Day1) to Weeks 12 and 24
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A fasting blood sample was collected and was sent to a central laboratory for analysis of adiponectin.
A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
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Baseline (Day1) to Weeks 12 and 24
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Change From Baseline in Serum Resistin Concentration
Time Frame: Baseline (Day 1) to Weeks 12 and 24
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A fasting blood sample was collected and was sent to a central laboratory for analysis of resistin.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 12 and 24
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Serum FFA at 30, 60, 90 and 120 Minutes Following Glucose Load
Time Frame: Pre-glucose load, 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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Blood was collected during the oral glucose tolerance test and was sent to a central laboratory for analysis of FFA.
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Pre-glucose load, 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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Change From Baseline in AUC (0-120 Min) for Serum FFA
Time Frame: Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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AUC(0-120 min) was derived from the serum FFA values obtained during the oral glucose tolerance test.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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Change From Baseline in AUC (30-120 Min) for Serum FFA
Time Frame: Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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AUC(30-120 min) was derived from the serum FFA values obtained during the oral glucose tolerance test.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24
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Change From Baseline in the Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)
Time Frame: Baseline (Screening) to Week 24
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Liver biopsy were performed during Screening and at Week 24 only for participants diagnosed with NASH.
NAFLD activity score was determined based on 3 components: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x) and hepatocellular ballooning (0=none to 2= many cells/prominent ballooning) for a total possible score of 0 to 8. A negative change from Baseline indicates improvement.
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Baseline (Screening) to Week 24
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Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Time Frame: Baseline (Screening) and Week 24
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Liver biopsy were performed during Screening and at Week 24 for participants diagnosed with NASH.
The NASH CRN Brunt/Kleiner Fibrosis Staging System Fibrosis Stages are: 0 (None), 1 (Perisinusoidal or periportal), 1A (Mild, zone 3, perisinusoidal), 1B (Moderate, zone 3, perisinusoidal), 1C (Portal/periportal), 2 (Perisinusoidal and portal/periportal), 3 (Bridging fibrosis) and 4 (Cirrhosis).
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Baseline (Screening) and Week 24
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Change From Baseline in Serum C-C Chemokine Receptor Type 2 (CCR2) Ligand: Monocyte Chemotactic Protein 1 (MCP-1)
Time Frame: Baseline (Day 1) to Weeks 2, 12 and 24
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Blood was collected and was sent to a central laboratory for analysis of MCP-1.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 2, 12 and 24
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Change From Baseline in Serum C-C Chemokine Receptor Type 5 (CCR5) Ligand: RANTES
Time Frame: Baseline (Day 1) to Weeks 2, 12 and 24
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Blood was collected and was sent to a central laboratory for analysis of RANTES (regulated on activation normal T-cell expressed and secreted).
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 2, 12 and 24
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Change From Baseline in Serum CCR5 Ligand: Macrophage Inflammatory Protein 1 Alpha (MIP-1α)
Time Frame: Baseline (Day 1) to Weeks 2, 12 and 24
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Blood was collected and was sent to a central laboratory for analysis of MIP-1α.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 2, 12 and 24
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Change From Baseline in Serum CCR5 Ligand: Macrophage Inflammatory Protein 1 Beta (MIP-1β)
Time Frame: Baseline (Day 1) to Weeks 2, 12 and 24
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Blood was collected and was sent to a central laboratory for analysis of MIP-1β.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 2, 12 and 24
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Change From Baseline in Biomarker of Inflammation: Interleukin 1 Beta (IL-1β)
Time Frame: Baseline (Day 1) to Weeks 2, 12 and 24
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Blood was collected and was sent to a central laboratory for analysis of IL-1β.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 2, 12 and 24
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Change From Baseline in Biomarker of Inflammation: Interleukin 6 (IL-6)
Time Frame: Baseline (Day 1) to Weeks 2, 12 and 24
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Blood was collected and was sent to a central laboratory for analysis of IL-6.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 2, 12 and 24
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Change From Baseline in Biomarker of Inflammation: Interleukin 8 (IL-8)
Time Frame: Baseline (Day 1) to Weeks 2, 12 and 24
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Blood was collected and was sent to a central laboratory for analysis of IL-8.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 2, 12 and 24
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Change From Baseline in Biomarker of Inflammation: Interleukin 10 (IL-10)
Time Frame: Baseline (Day 1) to Weeks 2, 12 and 24
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Blood was collected and was sent to a central laboratory for analysis of IL-1β.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 2, 12 and 24
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Change From Baseline in Biomarker of Inflammation: High Sensitivity C Reactive Protein (Hs-CRP)
Time Frame: Baseline (Day 1) to Weeks 2, 12, 24
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Blood was collected and was sent to a central laboratory for analysis of hs-CRP.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 2, 12, 24
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Change From Baseline in Biomarker of Inflammation: Tumor Necrosis Factor Alpha (TNF-α)
Time Frame: Baseline (Day 1) to Weeks 2, 12, 24
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Blood was collected and was sent to a central laboratory for analysis of TNF-α.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Weeks 2, 12, 24
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Change From Baseline in Noninvasive Metabolic Biomarker: Hyaluronic Acid
Time Frame: Baseline (Day 1) to Week 24
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Blood was collected and was sent to a central laboratory for analysis of Hyaluronic Acid.
A positive change from Baseline indicates improvement and a negative change from Baseline indicates improvement.
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Baseline (Day 1) to Week 24
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Change From Baseline in Noninvasive Metabolic Biomarker: Cytokeratin-18 (CK-18) [M30 and M65]
Time Frame: Baseline (Day 1) to Week 24
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Blood was collected and was sent to a central laboratory for analysis of CK-18.
A positive change from Baseline indicates improvement and a negative change from Baseline indicates improvement.
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Baseline (Day 1) to Week 24
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Change From Baseline in Noninvasive Metabolic Biomarker: Fibroblast Growth Factor-21 (FGF-21)
Time Frame: Baseline (Day 1) to Week 24
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Blood was collected and was sent to a central laboratory for analysis of FGF-21.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates improvement.
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Baseline (Day 1) to Week 24
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Change From Baseline in Noninvasive Metabolic Biomarker: Mac-2 Binding Protein (Mac-2BP)
Time Frame: Baseline (Day 1) to Week 24
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Blood was collected and was sent to a central laboratory for analysis of Mac-2BP.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates improvement.
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Baseline (Day 1) to Week 24
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Change From Baseline in Noninvasive Metabolic Serum Biomarker: Cluster of Differentiation (CD95)
Time Frame: Baseline (Day 1) to Week 24
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Blood was collected and was sent to a central laboratory for analysis of CD95.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Week 24
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Change From Baseline in Noninvasive Metabolic Marker: Alpha-fetoprotein (AFP)
Time Frame: Baseline (Day 1) to Week 24
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Blood was collected and was sent to a central laboratory for analysis of AFP.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline (Day 1) to Week 24
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Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Fat Fraction
Time Frame: Baseline to Weeks 12 and 24
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LiverMultiscan™ tests via MRI were obtained at Baseline and at Weeks 12 and 24.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline to Weeks 12 and 24
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Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Corrected T1 (cT1)
Time Frame: Baseline to Weeks 12 and 24
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LiverMultiscan™ via MRI were obtained at Baseline and at Weeks 12 and 24.
The mean of 4 regions of interest as selected by the technician is reported.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline to Weeks 12 and 24
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Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: cT1 Mode Values Within the Liver
Time Frame: Baseline to Weeks 12 and 24
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LiverMultiscan™ via MRI were obtained at Baseline and at Weeks 12 and 24.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline to Weeks 12 and 24
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Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Liver Inflammation and Fibrosis (LIF) Score
Time Frame: Baseline to Weeks 12 and 24
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LiverMultiscan™ tests via MRI were obtained at Baseline and at Weeks 12 and 24.
The mean of 4 regions of interest as selected by the technician is reported.
The LIF Score ranges from 0=no liver disease to 4=severe liver disease.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline to Weeks 12 and 24
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Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Iron Content
Time Frame: Baseline to Weeks 12 and 24
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LiverMultiscan™ tests via MRI were obtained at Baseline and at Weeks 12 and 24.
A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
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Baseline to Weeks 12 and 24
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Change From Baseline in Body Weight
Time Frame: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24
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Change From Baseline in Liver Transaminase: Alanine Aminotransferase (ALT)
Time Frame: Baseline to Weeks 12 and 24
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Blood was collected and was sent to a central laboratory for analysis of ALT.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline to Weeks 12 and 24
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Change From Baseline in Liver Transaminase: Aspartate Aminotransferase (AST)
Time Frame: Baseline to Weeks 12 and 24
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Blood was collected and was sent to a central laboratory for analysis of AST.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
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Baseline to Weeks 12 and 24
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Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time Frame: 24 weeks
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An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
A TEAE is an AE that occurs or worsens after receiving study drug.
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24 weeks
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Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs
Time Frame: 24 weeks
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Vital signs included Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Respiratory Rate and Temperature.
The investigator determined if the vital sign measurements were clinically relevant.
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24 weeks
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Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Time Frame: Baseline 24 weeks
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A standard 12 lead ECG was performed.
The investigator determined if the abnormal results were clinically significant.
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Baseline 24 weeks
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Plasma Cenicriviroc Concentrations
Time Frame: Baseline (Day 1) one sample predose; Weeks 2, 12 and 24 one sample predose and one sample postdose
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Baseline (Day 1) one sample predose; Weeks 2, 12 and 24 one sample predose and one sample postdose
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Number of Participants With Abnormal Physical Examination Findings
Time Frame: 24 weeks
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Physical examination included assessment of the following body systems: Abdomen, Cardiovascular, Extremities, Head, Eyes, Ears, Nose, Throat, Lungs, Lymph Nodes, Neurological, Skin and Thyroid.
The number of participants with any abnormal findings at Baseline and participants with any abnormal findings Post-Baseline are reported.
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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eric Lefebvre, MD, Allergan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2015
Primary Completion (Actual)
August 11, 2016
Study Completion (Actual)
September 8, 2016
Study Registration Dates
First Submitted
December 22, 2014
First Submitted That Met QC Criteria
December 31, 2014
First Posted (Estimate)
January 5, 2015
Study Record Updates
Last Update Posted (Actual)
October 11, 2019
Last Update Submitted That Met QC Criteria
September 17, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Hyperinsulinism
- Liver Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Fatty Liver
- Prediabetic State
- Insulin Resistance
- Non-alcoholic Fatty Liver Disease
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- CCR5 Receptor Antagonists
- Cenicriviroc
Other Study ID Numbers
- 652-2-204
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes Mellitus
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SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
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Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
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RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
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University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
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India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
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Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
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Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
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US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
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Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
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Diabetes Foundation, IndiaNational Diabetes Obesity and Cholesterol FoundationRecruitingType 2 Diabetes Mellitus With ComplicationIndia
Clinical Trials on Cenicriviroc 150 mg
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Tobira Therapeutics, Inc.CompletedPrimary Sclerosing CholangitisUnited States, Canada
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Massachusetts General HospitalCompletedAttention Deficit Hyperactivity DisorderUnited States
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Tobira Therapeutics, Inc.Completed
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Novartis PharmaceuticalsCompletedHypertensionUnited States, Belgium, Hungary, Turkey, Guatemala, Slovakia, Germany, Puerto Rico, Poland
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Georgetown UniversityUnknown
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Novartis PharmaceuticalsCompletedModerate to Severe Chronic Plaque-type PsoriasisUnited States, Hungary, Italy, Russian Federation, Germany, Czechia, Canada
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Samsung Medical CenterCompletedStomach NeoplasmsKorea, Republic of
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Tobira Therapeutics, Inc.Completed
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Tobira Therapeutics, Inc.Completed
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Bill & Melinda Gates Medical Research InstituteNot yet recruitingHealthy VolunteersKenya, Uganda