Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1330-5258 | Registry Identifier | ICTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Arrowhead Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
This is a randomized, double-blinded, placebo controlled, two periods phase 3 clinical study. The primary objective of the study was to evaluate the efficacy and safety of Plozasiran injection in Chinese adults with familial chylomicronemia syndrome (FCS). A total of 37 participants were enrolled in the study. The duration of the study randomized period was approximately 112 weeks, including a screening period of up to 8 weeks and a treatment period of up to 104 weeks. Participants who completed the randomized period will continue in a 1-year open-label extension period where all participants will receive Plozasiran.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plozasiran 25 mg | Experimental | Plozasiran 25 mg administered every 3 months for 12 months (randomized period), followed by an open-label period of 12 months |
|
| Plozasiran 50 mg | Experimental | Plozasiran 50 mg administered every 3 months for 12 months (randomized period), followed by an open-label period of 12 months |
|
| Placebo | Placebo Comparator | Matching placebo administered every 3 months for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plozasiran | Drug | Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Fasting Serum Triglyceride (TG) at Month 10 | Blood samples for lipid parameters were collected at the specified time points. Fasting serum TG at Month 10 was defined as geometric mean of 2 measurements taken during Month 10, or the other non-missing measurement if any one of the two measurements was missing during Month 10. Analysis was performed on the basis of the handling strategy for intercurrent events, missing fasting serum was imputed mainly based on the Pattern Mixture Models (PMM). Descriptive statistics were calculated based on non-imputed data. | Baseline to Month 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Fasting Serum TG at Months 10 and 12 (Averaged) | Blood samples for lipid parameters were collected at the specified time points. Fasting serum TG at Month 10 and Month 12 was defined as the geometric mean of the measurements in Month 10 and Month 12 or the non-missing measurement in the other month if measurement in any one of the two months was missing. Analysis was performed on the basis of the handling strategy for intercurrent events, missing fasting serum TG was imputed mainly based on the PMM. Descriptive statistics were calculated based on non-imputed data. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Current use or use within the last 365 days from Day 1 of any hepatocyte-targeted siRNA or antisense oligonucleotide molecule
Diabetes mellitus with any of the following:
Active pancreatitis within 12 weeks before Day 1
History of acute coronary syndrome event within 24 weeks of Day 1
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dong YOU, MD., PhD. | Visirna Therapeutics HK Limited | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | China |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Not provided
Not provided
Not provided
Not provided
A total of 37 participants were randomized and treated in this study. Participants were randomized in 1:1:1 ratio to receive Plozasiran 25 mg dose group, Plozasiran 50 mg dose group and matching placebo group.
A total of 63 participants were screened from 10-July-2023 to 19-Jan-2024, of which 26 participants were screen failures mainly due to selection criteria not met.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Plozasiran 25 mg | Plozasiran 25 mg administered every 3 months for 12 months (randomized period), followed by an open-label period of 12 months |
| FG001 | Plozasiran 50 mg | Plozasiran 50 mg administered every 3 months for 12 months (randomized period), followed by an open-label period of 12 months |
| FG002 | Placebo | Matching placebo administered every 3 months for 12 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Plozasiran 25 mg | Plozasiran 25 mg administered every 3 months for 12 months (randomized period), followed by an open-label period of 12 months |
| BG001 | Plozasiran 50 mg | Plozasiran 50 mg administered every 3 months for 12 months (randomized period), followed by an open-label period of 12 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Fasting Serum Triglyceride (TG) at Month 10 | Blood samples for lipid parameters were collected at the specified time points. Fasting serum TG at Month 10 was defined as geometric mean of 2 measurements taken during Month 10, or the other non-missing measurement if any one of the two measurements was missing during Month 10. Analysis was performed on the basis of the handling strategy for intercurrent events, missing fasting serum was imputed mainly based on the Pattern Mixture Models (PMM). Descriptive statistics were calculated based on non-imputed data. | Full analysis set (FAS), All randomized participants were included in FAS. All efficacy analyses were performed using the FAS. Participants were analyzed according to the study treatment assigned at randomization. For descriptive statistics, only participants with data collected for this outcome measure are reported. | Posted | Median | Full Range | Percent change | Baseline to Month 10 |
|
Adverse events (AE) data was collected from first dose of study treatment (Day 1) up to the Month 12. The data collection is ongoing for the Open-Label Extension period and the AE section will be updated after study completion.
Analysis was performed on the Safety population that included all randomized participants who had received at least 1 dose of the IP.
The data collection is ongoing for the Open-Label Extension period and the AE section will be updated after study completion.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plozasiran 25 mg | Plozasiran 25 mg administered every 3 months for 12 months (randomized period), followed by an open-label period of 12 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 ext 6# | Contact-US@sanofi.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2025 | Dec 3, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2025 | Dec 3, 2025 | SAP_003.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C538489 | Familial hyperchylomicronemia syndrome |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000731231 | plozasiran |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebon | Drug | Subcutaneous injection |
|
|
| Baseline to Months 10 and 12 (averaged) |
| Percent Change From Baseline in Fasting Serum Apolipoprotein C3 (APOC3) at Month 10 | Blood samples for lipid parameters were collected at the specified time points. Baseline of fasting serum APOC 3 was defined as the last non-missing value prior to or on the first dosing date. Analysis was performed on the basis of the handling strategy for intercurrent events, missing values were imputed using the PMM. Descriptive statistics were calculated based on non-imputed data. | Baseline to Month 10 |
| Percent Change From Baseline in Fasting Serum APOC3 at Month 12 | Blood samples for lipid parameters were collected at the specified time points. Baseline of fasting serum APOC 3 was defined as the last non-missing value prior to or on the first dosing date. Analysis was performed on the basis of the handling strategy for intercurrent events, missing values were imputed using the PMM. Descriptive statistics were calculated based on non-imputed data. | Baseline to Month 12 |
| Percent Change From Baseline in Fasting Serum Non-high Density Lipoprotein Cholesterol (Non-HDL-C) and High Density Lipoprotein Cholesterol (HDL-C) at Month 10 | Blood samples for lipid parameters were collected at the specified time points. Baseline was defined as the last non-missing value prior to or on the first dosing date. | Baseline to Month 10 |
| Percent Change From Baseline in Fasting Serum TG, Non-HDL-C, and HDL-C at Month 12 | Blood samples for lipid parameters were collected at the specified time points. Non-HDL-C and HDL-C baseline was defined as the last non-missing value prior to or on the first dosing date. | Baseline to Month 12 |
| Percentage of Participants Achieving Fasting Serum TG of <500 mg/dL at Month 10 | Blood samples for lipid parameters were collected at the specified time points. | 10 Month |
| Percentage of Participants Achieving Fasting Serum TG of <500 mg/dL at Month 12 | Blood samples for lipid parameters were collected at the specified time points. | 12 Month |
| Change From Baseline at Each Scheduled Assessment in Fasting Serum TG up to Month 12 | Blood samples for lipid parameters were collected at the specified time points. | From baseline up to Month 12, at Months 1,2,3,4,5,6,7,8,9,10,11 and 12 |
| Percent Change From Baseline at Each Scheduled Assessment in Fasting Serum TG up to Month 12 | Blood samples for lipid parameters were collected at the specified time points. | From baseline up to Month 12, at Months 1,2,3,4,5,6,7,8,9,10,11 and 12 |
| Number of Participants With Positively Adjudicated Events of Acute Pancreatitis | Any AEs and SAEs reported by the investigator during the study that were consistent with acute pancreatitis events were adjudicated by the blinded Data Safety Committee based on the Atlanta Classification for Acute Pancreatitis 2013 for fulfillment of any 2 of the following 3 criteria:
| From first administration of study treatment (Day 1) through Month 12. |
| Poor compliance and unable to receive treatment and attend visits as scheduled |
|
| Other reason |
|
| Subjects were transfered to the extension phase after unblinding due to an acute pancreatitis event |
|
| BG002 | Placebo | Matching placebo administered every 3 months for 12 months |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Fasting serum TG (mg/dL) | TG baseline was defined as the geometric mean of the results of the Day 1 (pre-dose) assessment and the last assessment prior to the first dose (excluding the day of the first dose). If any one of the two assessment results was missing, the other non-missing value would serve as baseline. | Mean | Standard Deviation | mg/dL |
|
Plozasiran 25 mg administered every 3 months for 12 months (randomized period), followed by an open-label period of 12 months |
| OG001 | Plozasiran 50 mg | Plozasiran 50 mg administered every 3 months for 12 months (randomized period), followed by an open-label period of 12 months |
| OG002 | Placebo | Matching placebo administered every 3 months for 12 months |
|
|
|
| Secondary | Percent Change From Baseline in Fasting Serum TG at Months 10 and 12 (Averaged) | Blood samples for lipid parameters were collected at the specified time points. Fasting serum TG at Month 10 and Month 12 was defined as the geometric mean of the measurements in Month 10 and Month 12 or the non-missing measurement in the other month if measurement in any one of the two months was missing. Analysis was performed on the basis of the handling strategy for intercurrent events, missing fasting serum TG was imputed mainly based on the PMM. Descriptive statistics were calculated based on non-imputed data. | Full analysis set (FAS), All randomized participants were included in FAS. All efficacy analyses were performed using the FAS. Participants were analyzed according to the study treatment assigned at randomization. For descriptive statistics, only participants with data collected for this outcome measure are reported. | Posted | Median | Full Range | Percent change | Baseline to Months 10 and 12 (averaged) |
|
|
|
|
| Secondary | Percent Change From Baseline in Fasting Serum Apolipoprotein C3 (APOC3) at Month 10 | Blood samples for lipid parameters were collected at the specified time points. Baseline of fasting serum APOC 3 was defined as the last non-missing value prior to or on the first dosing date. Analysis was performed on the basis of the handling strategy for intercurrent events, missing values were imputed using the PMM. Descriptive statistics were calculated based on non-imputed data. | Full analysis set (FAS), All randomized participants were included in FAS. All efficacy analyses were performed using the FAS. Participants were analyzed according to the study treatment assigned at randomization. For descriptive statistics, only participants with data collected for this outcome measure are reported. | Posted | Median | Full Range | Percent change | Baseline to Month 10 |
|
|
|
|
| Secondary | Percent Change From Baseline in Fasting Serum APOC3 at Month 12 | Blood samples for lipid parameters were collected at the specified time points. Baseline of fasting serum APOC 3 was defined as the last non-missing value prior to or on the first dosing date. Analysis was performed on the basis of the handling strategy for intercurrent events, missing values were imputed using the PMM. Descriptive statistics were calculated based on non-imputed data. | Full analysis set (FAS), All randomized participants were included in FAS. All efficacy analyses were performed using the FAS. Participants were analyzed according to the study treatment assigned at randomization. For descriptive statistics, only participants with data collected for this outcome measure are reported. | Posted | Median | Full Range | Percent change | Baseline to Month 12 |
|
|
|
|
| Secondary | Percent Change From Baseline in Fasting Serum Non-high Density Lipoprotein Cholesterol (Non-HDL-C) and High Density Lipoprotein Cholesterol (HDL-C) at Month 10 | Blood samples for lipid parameters were collected at the specified time points. Baseline was defined as the last non-missing value prior to or on the first dosing date. | Full analysis set (FAS), All randomized participants were included in FAS. All efficacy analyses were performed using the FAS. Participants were analyzed according to the study treatment assigned at randomization. Only participants with data collected for this outcome measure are reported. | Posted | Median | Full Range | Percent change | Baseline to Month 10 |
|
|
|
| Secondary | Percent Change From Baseline in Fasting Serum TG, Non-HDL-C, and HDL-C at Month 12 | Blood samples for lipid parameters were collected at the specified time points. Non-HDL-C and HDL-C baseline was defined as the last non-missing value prior to or on the first dosing date. | Full analysis set (FAS), All randomized participants were included in FAS. All efficacy analyses were performed using the FAS. Participants were analyzed according to the study treatment assigned at randomization. Only participants with data collected for this outcome measure are reported. | Posted | Median | Full Range | Percent change | Baseline to Month 12 |
|
|
|
| Secondary | Percentage of Participants Achieving Fasting Serum TG of <500 mg/dL at Month 10 | Blood samples for lipid parameters were collected at the specified time points. | Full analysis set (FAS), All randomized participants were included in FAS. All efficacy analyses were performed using the FAS. Participants were analyzed according to the study treatment assigned at randomization. Only participants with data collected for this outcome measure are reported. | Posted | Number | Percentage of participants | 10 Month |
|
|
|
| Secondary | Percentage of Participants Achieving Fasting Serum TG of <500 mg/dL at Month 12 | Blood samples for lipid parameters were collected at the specified time points. | Posted | Number | Percentage of participants | 12 Month |
|
|
|
| Secondary | Change From Baseline at Each Scheduled Assessment in Fasting Serum TG up to Month 12 | Blood samples for lipid parameters were collected at the specified time points. | Full analysis set (FAS), All randomized participants were included in FAS. All efficacy analyses were performed using the FAS. Participants were analyzed according to the study treatment assigned at randomization. Only participants with data collected for this outcome measure are reported. | Posted | Median | Full Range | mmol/L | From baseline up to Month 12, at Months 1,2,3,4,5,6,7,8,9,10,11 and 12 |
|
|
|
| Secondary | Percent Change From Baseline at Each Scheduled Assessment in Fasting Serum TG up to Month 12 | Blood samples for lipid parameters were collected at the specified time points. | Full analysis set (FAS), All randomized participants were included in FAS. All efficacy analyses were performed using the FAS. Participants were analyzed according to the study treatment assigned at randomization. Only participants with data collected for this outcome measure are reported. | Posted | Median | Full Range | Percent change | From baseline up to Month 12, at Months 1,2,3,4,5,6,7,8,9,10,11 and 12 |
|
|
|
| Secondary | Number of Participants With Positively Adjudicated Events of Acute Pancreatitis | Any AEs and SAEs reported by the investigator during the study that were consistent with acute pancreatitis events were adjudicated by the blinded Data Safety Committee based on the Atlanta Classification for Acute Pancreatitis 2013 for fulfillment of any 2 of the following 3 criteria:
| Full analysis set (FAS), All randomized participants were included in FAS. All efficacy analyses were performed using the FAS. Participants were analyzed according to the study treatment assigned at randomization | Posted | Count of Participants | Participants | From first administration of study treatment (Day 1) through Month 12. |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| 11 |
| 12 |
| EG001 | Plozasiran 50 mg | Plozasiran 50 mg administered every 3 months for 12 months (randomized period), followed by an open-label period of 12 months | 0 | 12 | 0 | 12 | 10 | 12 |
| EG002 | Placebo | Matching placebo administered every 3 months for 12 months | 0 | 13 | 4 | 13 | 12 | 13 |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Renal hydrocele | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Red blood cell count increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Haemoglobin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Noninfective gingivitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Impaired fasting glucose | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Diabetic ketosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Viral rash | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| IVth nerve paralysis | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Laryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Refraction disorder | Eye disorders | MedDRA 27.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 27.1 | Systematic Assessment |
|
| Central serous chorioretinopathy | Eye disorders | MedDRA 27.1 | Systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
Not provided
Not provided
| Superiority |
To control the overall type I error at a 0.05 level, a sequential strategy was implemented for comparison for multiplicity following a fixed sequence. The hypothesis testing procedure was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 3 secondary outcome measures were included in the procedure. |
| Analysis was performed using a non-parametric test method, where continuity-corrected Wilcoxon (Mann-Whitney) rank sum test of the significance of the median difference between groups (active treatment groups and placebo group) was performed, and the Hodges-Lehmann method was used to estimate the median difference between groups and their 95% confidence intervals. | Wilcoxon (Mann-Whitney) | 0.0051 | Adjusted P value referred to the P value adjusted for multiplicity using the Holm method for comparison between two dose groups. Threshold for significance at two-sided 0.05 level. | Median Difference (Final Values) | -85.0 | 2-Sided | 95 | -166.4 | -3.6 | The Hodges-Lehmann method was used, the estimator represents the median of all possible paired differences between the two groups, rather than the direct subtraction of their individual medians. | Superiority | To control the overall type I error at a 0.05 level, a sequential strategy was implemented for comparison for multiplicity following a fixed sequence. The hypothesis testing procedure was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 3 secondary outcome measures were included in the procedure. |
| Superiority |
To control the overall type I error at a 0.05 level, a sequential strategy was implemented for comparison for multiplicity following a fixed sequence. The hypothesis testing procedure was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 3 secondary outcome measures were included in the procedure. |
| Analysis was performed using a non-parametric test method, where continuity-corrected Wilcoxon (Mann-Whitney) rank sum test of the significance of the median difference between groups (active treatment groups and placebo group) was performed, and the Hodges-Lehmann method was used to estimate the median difference between groups and their 95% confidence intervals. | Wilcoxon (Mann-Whitney) | 0.0004 | Adjusted P value referred to the P value adjusted for multiplicity using the Holm method for comparison between two dose groups. Threshold for significance at two-sided 0.05 level. | Median Difference (Final Values) | -115.25 | 2-Sided | 95 | -141.89 | -88.61 | The Hodges-Lehmann method was used, the estimator represents the median of all possible paired differences between the two groups, rather than the direct subtraction of their individual medians. | Superiority | To control the overall type I error at a 0.05 level, a sequential strategy was implemented for comparison for multiplicity following a fixed sequence. The hypothesis testing procedure was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 3 secondary outcome measures were included in the procedure. |
| Superiority |
To control the overall type I error at a 0.05 level, a sequential strategy was implemented for comparison for multiplicity following a fixed sequence. The hypothesis testing procedure was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 3 secondary outcome measures were included in the procedure. |
| Analysis was performed using a non-parametric test method, where continuity-corrected Wilcoxon (Mann-Whitney) rank sum test of the significance of the median difference between groups (active treatment groups and placebo group) was performed, and the Hodges-Lehmann method was used to estimate the median difference between groups and their 95% confidence intervals. | Wilcoxon (Mann-Whitney) | 0.0008 | Adjusted P value referred to the P value adjusted for multiplicity using the Holm method for comparison between two dose groups. Threshold for significance at two-sided 0.05 level. | Median Difference (Final Values) | -114.36 | 2-Sided | 95 | -175.31 | -53.40 | The Hodges-Lehmann method was used, the estimator represents the median of all possible paired differences between the two groups, rather than the direct subtraction of their individual medians. | Superiority | To control the overall type I error at a 0.05 level, a sequential strategy was implemented for comparison for multiplicity following a fixed sequence. The hypothesis testing procedure was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 3 secondary outcome measures were included in the procedure. |
| Percent change in fasting serum HDL-C |
|
| Percent change in fasting serum Non-HDL-C |
|
|
| Percent change in fasting serum HDL-C |
|
|
| Change from baseline in fasting serum TG at month 2 |
|
|
| Change from baseline in fasting serum TG at month 3 |
|
|
| Change from baseline in fasting serum TG at month 4 |
|
|
| Change from baseline in fasting serum TG at month 5 |
|
|
| Change from baseline in fasting serum TG at month 6 |
|
|
| Change from baseline in fasting serum TG at month 7 |
|
|
| Change from baseline in fasting serum TG at month 8 |
|
|
| Change from baseline in fasting serum TG at month 9 |
|
|
| Change from baseline in fasting serum TG at month 10 |
|
|
| Change from baseline in fasting serum TG at month 11 |
|
|
| Change from baseline in fasting serum TG at month 12 |
|
|
| Percent change from baseline in fasting serum TG at month 2 |
|
|
| Percent change from baseline in fasting serum TG at month 3 |
|
|
| Percent change from baseline in fasting serum TG at month 4 |
|
|
| Percent change from baseline in fasting serum TG at month 5 |
|
|
| Percent change from baseline in fasting serum TG at month 6 |
|
|
| Percent change from baseline in fasting serum TG at month 7 |
|
|
| Percent change from baseline in fasting serum TG at month 8 |
|
|
| Percent change from baseline in fasting serum TG at month 9 |
|
|
| Percent change from baseline in fasting serum TG at month 10 |
|
|
| Percent change from baseline in fasting serum TG at month 11 |
|
|
| Percent change from baseline in fasting serum TG at month 12 |
|
|