Trial · NCT02330549
ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) and Suspected NAFLD
NCT02330549, Phase 2, Completed, Tobira Therapeutics, Inc.; results first posted 2019-10-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) and Suspected NAFLD. Trials, record NCT02330549. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02330549
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) and Suspected NAFLD
- NCT number
- NCT02330549
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Tobira Therapeutics, Inc.
- Conditions
- Prediabetic State, Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus
- Interventions
- Cenicriviroc 150 mg, Placebo
- First posted
- 2015-01-05
- Last updated
- 2019-10-11
- Results first posted
- 2019-10-11
Source ClinicalTrials.gov
Registered outcomes55
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Matsuda Index | Baseline (Day 1) to Weeks 12 and 24 | 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. |
| Primary | Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR ) Index | Baseline (Day 1) to Weeks 12 and 24 | 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. |
| Secondary | Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue | Baseline (Day 1) to Week 24 | 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. |
| Secondary | Change From Baseline in C-C Chemokine Receptor Type 2 (CCR2) and C-C Chemokine Receptor Type 5 (CCR5) in Subcutaneous Adipose Tissue | Baseline (Day 1) to Week 24 | 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. |
| Secondary | Change From Baseline in Peripheral Monocyte Subsets (CD14/CD16) | Baseline (Day 1) to Week 24 | 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. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline (Day1) to Weeks 12 and 24 | 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. |
| Secondary | Change From Baseline in Fasting Plasma Insulin (FPI) | Baseline (Day 1) to Weeks 12 and 24 | 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. |
| Secondary | Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) | Baseline (Day1) to Weeks 12 and 24 | 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. |
| Secondary | Change From Baseline in Homeostasis Model of Insulin Resistance (HOMA-IR) | Baseline (Day 1) to Weeks 12 and 24 | 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. |
| Secondary | Change From Baseline in Homeostasis Model Assessment of β-cell Function (HOMA-%B) | Baseline (Day 1) to Weeks 12 and 24 | HOMA-%B= (20 × FPI)/(FPG - 3.5). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening. |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 registered outcomesOutcomes55
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Matsuda Index | Baseline (Day 1) to Weeks 12 and 24 | Intent to treat (ITT) population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | unit on a scale | MEAN |
| PRIMARY | Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR ) Index | Baseline (Day 1) to Weeks 12 and 24 | ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | unit on a scale | MEAN |
| SECONDARY | Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue | Baseline (Day 1) to Week 24 | Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis at the given timepoint. | cells/μL | MEDIAN |
| SECONDARY | Change From Baseline in C-C Chemokine Receptor Type 2 (CCR2) and C-C Chemokine Receptor Type 5 (CCR5) in Subcutaneous Adipose Tissue | Baseline (Day 1) to Week 24 | Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available at the given timepoint | copies per sample | MEDIAN |
| SECONDARY | Change From Baseline in Peripheral Monocyte Subsets (CD14/CD16) | Baseline (Day 1) to Week 24 | Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis at the given timepoint. | cells/μL | MEDIAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline (Day1) to Weeks 12 and 24 | ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Insulin (FPI) | Baseline (Day 1) to Weeks 12 and 24 | ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | μIU/mL | MEAN |
| SECONDARY | Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) | Baseline (Day1) to Weeks 12 and 24 | ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | unit on a scale | MEAN |
| SECONDARY | Change From Baseline in Homeostasis Model of Insulin Resistance (HOMA-IR) | Baseline (Day 1) to Weeks 12 and 24 | ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | unit on a scale | MEAN |
| SECONDARY | Change From Baseline in Homeostasis Model Assessment of β-cell Function (HOMA-%B) | Baseline (Day 1) to Weeks 12 and 24 | ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint. | unit on a scale | MEAN |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 outcomesResults by group427
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Matsuda Index | Cenicriviroc 150 mg | Baseline | 1.22 | Standard Deviation 0.661 | unit on a scale |
| Change From Baseline in Matsuda Index | Placebo | Baseline | 1.04 | Standard Deviation 0.595 | unit on a scale |
| Change From Baseline in Matsuda Index | Cenicriviroc 150 mg | Change from Baseline to Week 12 | -0.02 | Standard Deviation 0.348 | unit on a scale |
| Change From Baseline in Matsuda Index | Placebo | Change from Baseline to Week 12 | 0.24 | Standard Deviation 0.656 | unit on a scale |
| Change From Baseline in Matsuda Index | Cenicriviroc 150 mg | Change from Baseline to Week 24 | 0.03 | Standard Deviation 0.449 | unit on a scale |
| Change From Baseline in Matsuda Index | Placebo | Change from Baseline to Week 24 | 0.41 | Standard Deviation 0.674 | unit on a scale |
| Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR ) Index | Cenicriviroc 150 mg | Baseline | 17.77 | Standard Deviation 14.074 | unit on a scale |
| Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR ) Index | Placebo | Baseline | 17.74 | Standard Deviation 9.406 | unit on a scale |
| Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR ) Index | Cenicriviroc 150 mg | Change from Baseline to Week 12 | -1.41 | Standard Deviation 9.009 | unit on a scale |
| Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR ) Index | Placebo | Change from Baseline to Week 12 | -0.52 | Standard Deviation 8.745 | unit on a scale |
1 to 10 of 427Source ClinicalTrials.gov
See all 427 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cenicriviroc 150 mg | 20 | |
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | COMPLETED | Cenicriviroc 150 mg | 16 | |
| Overall Study | COMPLETED | Placebo | 24 | |
| Overall Study | NOT COMPLETED | Cenicriviroc 150 mg | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Cenicriviroc 150 mg | 0 | 20 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 2 | 25 | |
| other | Nausea | Gastrointestinal disorders | Cenicriviroc 150 mg | 0 | 20 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 25 | |
| other | Diarrhoea | Gastrointestinal disorders | Cenicriviroc 150 mg | 1 | 20 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 25 | |
| other | Abdominal pain | Gastrointestinal disorders | Cenicriviroc 150 mg | 1 | 20 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 25 | |
| other | Seasonal allergy | Immune system disorders | Cenicriviroc 150 mg | 1 | 20 | |
| other | Seasonal allergy | Immune system disorders | Placebo | 0 | 25 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cenicriviroc 150 mg | 0 | 20 |
| Total, all-cause mortality | Placebo | 0 | 25 |
| Total, other adverse events | Cenicriviroc 150 mg | 10 | 20 |
| Total, other adverse events | Placebo | 11 | 25 |
| Total, serious adverse events | Cenicriviroc 150 mg | 0 | 20 |
| Total, serious adverse events | Placebo | 1 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cenicriviroc 150 mg vs Placebo: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) | Trial comparisons |
| Cenicriviroc 150 mg vs Placebo: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | Trial comparisons |
| Cenicriviroc 150 mg vs Placebo: deaths from any cause | Trial comparisons |
| Cenicriviroc 150 mg vs Placebo: Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs | Trial comparisons |
| Cenicriviroc 150 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02330549
GET https://conductscience.org/api/trials/v1/NCT02330549/registered?page=2