Trial · NCT03960541
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Baseline and Week 6 | All randomized participants who received ≥1 dose of study drug. | Percent Change | MEAN |
| PRIMARY | Number of Participants With ≥1 Adverse Event (AE) | Up to approximately 28 weeks | All randomized participants who received ≥1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Withdrew From Study Treatment Due to an AE | Up to approximately 4 weeks | All randomized participants who received ≥1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein-Cholesterol (HDL-C), and Triglycerides | Baseline, Week 6, and Week 28 | All randomized participants who received ≥1 dose of study drug. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in Cluster of Differentiation 4 (CD4)+ and Cluster of Differentiation 8 (CD8)+ T Cell Percentage | Baseline, Week 6, and Week 28 | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | ||
| SECONDARY | Percent Change From Baseline in Interferon (IFN)+ Peripheral Blood Mononuclear Cells (PBMCs) | Baseline, Week 6, and Week 28 | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | ||
| SECONDARY | Percent Change From Baseline in Tumor Necrosis Factor (TNF)+ Peripheral Blood Mononuclear Cells (PBMCs) | Baseline, Week 6, and Week 28 | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | ||
| SECONDARY | Percent Change From Baseline in Whole Blood Soluble Cluster of Differentiation 14 (sCD14) Concentration | Baseline, Week 6, and Week 28 | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | ||
| SECONDARY | Change From Baseline in Human Immunodeficiency Virus (HIV) Proviral Deoxyribonucleic Acid (DNA) | Baseline, Week 6, and Week 28 | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | ||
| SECONDARY | Percent Change From Baseline in Troponin I and Troponin T Serum Levels | Baseline and Week 28 | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Results for baseline and/or Week 28 were not quantifiable for any participants, so the change from baseline analysis could not be performed and no participants were analyzed. | ||
| SECONDARY | Percent Change From Baseline in Controlled Attenuation Parameter (CAP) as Determined by Transient Elastography of the Liver | Baseline and Week 28 | All randomized participants who received ≥1 dose of study drug. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in Liver Stiffness as Determined by Transient Elastography of the Liver | Baseline and Week 28 | All randomized participants who received ≥1 dose of study drug. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in Leptin | Baseline, Week 6, and Week 28 | All randomized participants who received ≥1 dose of study drug. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in Glycated Hemoglobin (HbA1c) | Baseline, Week 6, and Week 28 | All randomized participants who received ≥1 dose of study drug. | Percent Change | MEAN |
| SECONDARY | Area Under the Plasma Concentration Versus Time Curve (AUC) of CD24Fc | Predose and 2 hours postdose at the Week 0, 2, and 4 visits; Any time during the Week 6, 16, and 28 visits. | The intended analysis population was all randomized participants who received ≥1 dose of study drug. The estimated time to set up new validated assays exceeds the known stability of collected samples; therefore the samples will not be analyzed. Therefore, no participants were analyzed. | ||
| SECONDARY | Number of Participants With New Anti-Drug Antibodies | Baseline, Week 6, and Week 28 | The intended analysis population was all randomized participants who received ≥1 dose of study drug. The estimated time to set up new validated assays exceeds the known stability of collected samples; therefore the samples will not be analyzed. Therefore, no participants were analyzed. | ||
| SECONDARY | Change From Baseline in Interluekin-6 (IL-6) Levels Following CD24Fc Treatment | Baseline and Week 28 | The intended analysis population was all randomized participants who received ≥1 dose of study drug. No samples were collected for Week 28, so the change from baseline analysis could not be performed and no participants were analyzed. | ||
| SECONDARY | Change From Baseline in Apolipoprotein B (apoB) Levels | Baseline and Week 28 | All randomized participants who received ≥1 dose of study drug. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Lipoprotein(a) (Lp[a]) Levels | Baseline and Week 28 | All randomized participants who received ≥1 dose of study drug. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Urine Albumin:Creatinine Ratio | Baseline and Week 28 | All randomized participants who received ≥1 dose of study drug and had data available for the specified time point. | Ratio (g Albumin/mol Creatinine) | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
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