Familial Chylomicronemia Syndrome (FCS) (HLP Type I)
Conditions
Keywords
Familial Chylomicronemia Syndrome (FCS) (HLP type I), LCQ908
Brief summary
This study was to determine long-term safety and tolerability, and continued efficacy in lowering triglycerides of LCQ908 in subjects with Familial Chylomicronemia Syndrome (FCS) (HLP type I).
Detailed description
This study was an 52 weeks open label extension starting at the lowest treatment dose used in CLCQ908B2302/NCT01514461 (i.e., 10 mg) with optional up-titrations, to evaluate the overall long-term safety and tolerability of LCQ908 in patients with Familial Chylomicronemia Syndrome, who either discontinued from the CLCQ908B2302/NCT01514461 study (due to tolerability issues) or completed the CLCQ908B2302/NCT01514461 study after 52 weeks. In addition, patients who had previously completed study CLCQ908A2212/NCT01146522 were eligible to participate. Following Protocol amendment 2, the original 52 week duration of this study (CLCQ908B2305) became Part A of LCQ908B2305 and a 78 week extension became Part B. However, following Protocol amendment 3, Part B was ended at the same time as the last patient of Part A completed 52 weeks. The reason for termination of Part B was the findings from the December 2014 interim analysis which suggested that the size of benefit that was anticipated from continued participation of patients in the 18 month extension trial (Part B) no longer supported trial extension beyond Part A.
Interventions
DRUGLCQ908
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent must be obtained before any assessment is performed. 2. Subjects that either discontinue prematurely or complete the CLCQ908B2302 study after 52 weeks or FCS subjects who have previously completed study CLCQ908A2212.
Exclusion criteria
1. Subjects discontinued from the CLCQ908B2302 study for serious, potentially study drug related adverse events. 2. Subjects from the CLCQ908B2302 study who have developed any other contraindication to participation (for example, renal failure) 3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 4. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 5. Subjects with type 1 diabetes mellitus or type 2 diabetes mellitus if HbA1C is ≥ 8.5%. 6. Treatment with fish oil preparations within 4 weeks prior to randomization. 7. Treatment with bile acid binding resins (i.e., colesevelam, etc) within 4 weeks prior to randomization. 8. Treatment with fibrates within 8 weeks prior to randomization. Washout may occur following screening if required. 9. Glybera \[alipogene tiparvovec (AAV1-LPLS447X )\] gene therapy exposure within the two years prior to screening. 10. eGFR \<45 ml/min/1.73m2 or history of chronic renal disease. Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients With Any Adverse Events, Serious Adverse Events and Death | 52 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Triglyceride Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Blood samples were collected for a fasting lipid panel, including total triglycerides. Lipid measurements were collected after a 12 hour (overnight) fast. The maintenance of effect was assessed on triglyceride levels during continued therapy with LCQ908 for up to 52 weeks. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
| Changes From Baseline in Cholesterol Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Blood samples were collected for a fasting lipid panel, including cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
| Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Blood samples were collected for a fasting lipid panel, including HDL and non HDL cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
| Changes From Baseline in Glycerol Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Blood samples were collected for a fasting lipid panel, including glycerol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
| Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Blood samples were collected for a fasting lipid panel, including free fatty acid level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
| Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein A1. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
| Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-48. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
| Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | Baseline, Week 12, 24 and 52 | Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-100. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100. |
Countries
Canada, France, Germany, Netherlands, South Africa, United Kingdom, United States
Participant flow
Pre-assignment details
100% patients who completed the screening phase were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo of Pradigastat (LCQ908) Regimen Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | 11 |
| 20 mg Pradigastat (LCQ908) Regimen Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | 12 |
| 40 mg Pradigastat (LCQ908) Regimen Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
Part B: Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | 10 |
| Pradigastat (LCQ908) Regimen- From Study A2212 Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients' tolerance and safety profile. | 5 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Part A (52 Weeks) | Subject/guardian decision | 2 | 3 | 2 | 0 |
| Part B (Planned for 78 Week-terminated) | Physician Decision | 0 | 0 | 0 | 1 |
| Part B (Planned for 78 Week-terminated) | Study terminated by sponsor | 5 | 5 | 4 | 3 |
| Part B (Planned for 78 Week-terminated) | Subject/guardian decision | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo of Pradigastat (LCQ908) Regimen | 20 mg Pradigastat (LCQ908) Regimen | 40 mg Pradigastat (LCQ908) Regimen | Pradigastat (LCQ908) Regimen- From Study A2212 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 52.9 Years STANDARD_DEVIATION 10.22 | 44.1 Years STANDARD_DEVIATION 14.26 | 43.6 Years STANDARD_DEVIATION 84.53 | 52.2 Years STANDARD_DEVIATION 12.72 | 47.6 Years STANDARD_DEVIATION 11.43 |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 2 Participants | 3 Participants | 16 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 8 Participants | 2 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 11 | 12 / 12 | 10 / 10 | 5 / 5 | 4 / 5 | 3 / 6 | 3 / 4 | 0 / 4 |
| serious Total, serious adverse events | 1 / 11 | 6 / 12 | 2 / 10 | 2 / 5 | 0 / 5 | 0 / 6 | 0 / 4 | 0 / 4 |
Outcome results
Primary
Number of Patients With Any Adverse Events, Serious Adverse Events and Death
Time frame: 52 weeks
Population: Safety set (SAF) - All subjects who received at least one dose of study drug and had at least one post-baseline safety assessment in this extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo of Pradigastat (LCQ908) Regimen | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | At least one Adverse Event (any) | 11 Participants |
| Placebo of Pradigastat (LCQ908) Regimen | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | Death | 0 Participants |
| Placebo of Pradigastat (LCQ908) Regimen | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | At least one serious AE | 1 Participants |
| 20 mg Pradigastat (LCQ908) Regimen | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | At least one Adverse Event (any) | 12 Participants |
| 20 mg Pradigastat (LCQ908) Regimen | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | Death | 0 Participants |
| 20 mg Pradigastat (LCQ908) Regimen | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | At least one serious AE | 6 Participants |
| 40 mg Pradigastat (LCQ908) Regimen | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | At least one serious AE | 2 Participants |
| 40 mg Pradigastat (LCQ908) Regimen | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | At least one Adverse Event (any) | 10 Participants |
| 40 mg Pradigastat (LCQ908) Regimen | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | Death | 0 Participants |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | At least one Adverse Event (any) | 5 Participants |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | Death | 0 Participants |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | At least one serious AE | 2 Participants |
Secondary
Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks
Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein A1. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100.
Time frame: Baseline, Week 12, 24 and 52
Population: Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | Change in week 12 (n=11,11,10,5) | -3.24 percentage change | Geometric Coefficient of Variation 23.82 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | change in week 24 (n=10,10,10,5) | 4.80 percentage change | Geometric Coefficient of Variation 14.16 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | change in week 52 (n=10,8,9,5) | 4.51 percentage change | Geometric Coefficient of Variation 19.21 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | change in week 52 (n=10,8,9,5) | 10.01 percentage change | Geometric Coefficient of Variation 16.28 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | change in week 24 (n=10,10,10,5) | 1.41 percentage change | Geometric Coefficient of Variation 17.45 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | Change in week 12 (n=11,11,10,5) | 2.55 percentage change | Geometric Coefficient of Variation 15.09 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | change in week 24 (n=10,10,10,5) | 5.57 percentage change | Geometric Coefficient of Variation 25.69 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | change in week 52 (n=10,8,9,5) | 4.43 percentage change | Geometric Coefficient of Variation 19.34 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | Change in week 12 (n=11,11,10,5) | 6.58 percentage change | Geometric Coefficient of Variation 17.04 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | change in week 52 (n=10,8,9,5) | -0.82 percentage change | Geometric Coefficient of Variation 16.79 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | Change in week 12 (n=11,11,10,5) | 2.95 percentage change | Geometric Coefficient of Variation 33.54 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks | change in week 24 (n=10,10,10,5) | 5.11 percentage change | Geometric Coefficient of Variation 28.49 |
Secondary
Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks
Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-100. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100.
Time frame: Baseline, Week 12, 24 and 52
Population: Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | Change in week 12 (n=9,11,9,5) | -15.75 percentage change | Geometric Coefficient of Variation 41.5 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | change in week 52 (n=10,7,9,5) | -12.52 percentage change | Geometric Coefficient of Variation 44.16 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | change in week 24 (n=10,9,10,5) | -2.75 percentage change | Geometric Coefficient of Variation 63.1 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | Change in week 12 (n=9,11,9,5) | 15.10 percentage change | Geometric Coefficient of Variation 58.53 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | change in week 52 (n=10,7,9,5) | 25.39 percentage change | Geometric Coefficient of Variation 36.77 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | change in week 24 (n=10,9,10,5) | 21.33 percentage change | Geometric Coefficient of Variation 38.76 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | Change in week 12 (n=9,11,9,5) | -8.34 percentage change | Geometric Coefficient of Variation 32.73 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | change in week 52 (n=10,7,9,5) | -10.73 percentage change | Geometric Coefficient of Variation 37.2 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | change in week 24 (n=10,9,10,5) | -18.28 percentage change | Geometric Coefficient of Variation 52.94 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | Change in week 12 (n=9,11,9,5) | 3.33 percentage change | Geometric Coefficient of Variation 32.46 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | change in week 24 (n=10,9,10,5) | 11.68 percentage change | Geometric Coefficient of Variation 43.73 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks | change in week 52 (n=10,7,9,5) | 10.02 percentage change | Geometric Coefficient of Variation 39.08 |
Secondary
Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks
Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-48. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100.
Time frame: Baseline, Week 12, 24 and 52
Population: Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | Change in week 12 (n=11,11,10,5) | -4.03 percentage change | Geometric Coefficient of Variation 79.87 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | change in week 24 (n=10,10,10,5) | 9.13 percentage change | Geometric Coefficient of Variation 30.79 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | change in week 52 (n=10,8,9,5) | 56.25 percentage change | Geometric Coefficient of Variation 57.65 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | change in week 52 (n=10,8,9,5) | -22.63 percentage change | Geometric Coefficient of Variation 107.21 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | Change in week 12 (n=11,11,10,5) | 33.24 percentage change | Geometric Coefficient of Variation 79.2 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | change in week 24 (n=10,10,10,5) | -10.23 percentage change | Geometric Coefficient of Variation 58.91 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | Change in week 12 (n=11,11,10,5) | 109.67 percentage change | Geometric Coefficient of Variation 52.5 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | change in week 24 (n=10,10,10,5) | 105.52 percentage change | Geometric Coefficient of Variation 71.45 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | change in week 52 (n=10,8,9,5) | 135.33 percentage change | Geometric Coefficient of Variation 71.11 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | change in week 52 (n=10,8,9,5) | 27.75 percentage change | Geometric Coefficient of Variation 57.77 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | change in week 24 (n=10,10,10,5) | -35.04 percentage change | Geometric Coefficient of Variation 31.11 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks | Change in week 12 (n=11,11,10,5) | -30.03 percentage change | Geometric Coefficient of Variation 61.78 |
Secondary
Changes From Baseline in Cholesterol Levels up to 52 Weeks
Blood samples were collected for a fasting lipid panel, including cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100.
Time frame: Baseline, Week 12, 24 and 52
Population: Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Cholesterol Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | -5.58 percentage change | Geometric Coefficient of Variation 36.38 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Cholesterol Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | 5.75 percentage change | Geometric Coefficient of Variation 17.51 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Cholesterol Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | -10.54 percentage change | Geometric Coefficient of Variation 27.87 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Cholesterol Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | -4.76 percentage change | Geometric Coefficient of Variation 36.26 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Cholesterol Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | -13.76 percentage change | Geometric Coefficient of Variation 36.1 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Cholesterol Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | -21.54 percentage change | Geometric Coefficient of Variation 24.98 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Cholesterol Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | 7.45 percentage change | Geometric Coefficient of Variation 37.28 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Cholesterol Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | 18.76 percentage change | Geometric Coefficient of Variation 31.54 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Cholesterol Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | 40.95 percentage change | Geometric Coefficient of Variation 34.1 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Cholesterol Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | -10.42 percentage change | Geometric Coefficient of Variation 24.68 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Cholesterol Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | -6.84 percentage change | Geometric Coefficient of Variation 22.55 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Cholesterol Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | -13.87 percentage change | Geometric Coefficient of Variation 25.64 |
Secondary
Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks
Blood samples were collected for a fasting lipid panel, including free fatty acid level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100.
Time frame: Baseline, Week 12, 24 and 52
Population: Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | -23.11 percentage change | Geometric Coefficient of Variation 53.05 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | -20.35 percentage change | Geometric Coefficient of Variation 80.16 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | -16.99 percentage change | Geometric Coefficient of Variation 43.34 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | -30.44 percentage change | Geometric Coefficient of Variation 62.01 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | -17.85 percentage change | Geometric Coefficient of Variation 62.48 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | -7.69 percentage change | Geometric Coefficient of Variation 54.21 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | 53.09 percentage change | Geometric Coefficient of Variation 44.83 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | 36.18 percentage change | Geometric Coefficient of Variation 64.97 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | 79.15 percentage change | Geometric Coefficient of Variation 49.37 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | -42.74 percentage change | Geometric Coefficient of Variation 108.73 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | -18.29 percentage change | Geometric Coefficient of Variation 104.77 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | -46.58 percentage change | Geometric Coefficient of Variation 128.38 |
Secondary
Changes From Baseline in Glycerol Levels up to 52 Weeks
Blood samples were collected for a fasting lipid panel, including glycerol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100.
Time frame: Baseline, Week 12, 24 and 52
Population: Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Glycerol Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | -26.56 percentage change | Geometric Coefficient of Variation 72.88 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Glycerol Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | -38.15 percentage change | Geometric Coefficient of Variation 70.1 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Glycerol Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | -40.00 percentage change | Geometric Coefficient of Variation 67.28 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Glycerol Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | -46.97 percentage change | Geometric Coefficient of Variation 62.46 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Glycerol Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | -31.96 percentage change | Geometric Coefficient of Variation 64.76 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Glycerol Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | -15.50 percentage change | Geometric Coefficient of Variation 73.33 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Glycerol Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | 0.68 percentage change | Geometric Coefficient of Variation 75.4 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Glycerol Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | -36.26 percentage change | Geometric Coefficient of Variation 133.58 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Glycerol Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | -28.52 percentage change | Geometric Coefficient of Variation 101.85 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Glycerol Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | -56.99 percentage change | Geometric Coefficient of Variation 96.06 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Glycerol Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | -37.02 percentage change | Geometric Coefficient of Variation 81.67 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Glycerol Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | -46.83 percentage change | Geometric Coefficient of Variation 105.58 |
Secondary
Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks
Blood samples were collected for a fasting lipid panel, including HDL and non HDL cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100.
Time frame: Baseline, Week 12, 24 and 52
Population: Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | HDL: change in week 24 (n=10,10,9,5) | -7.11 percentage change | Geometric Coefficient of Variation 19.41 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | HDL: change in week 52 (n=9,8,9,5) | -10.85 percentage change | Geometric Coefficient of Variation 19.78 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Non HDL: change in week 24 (n=10,10,9,5) | -11.29 percentage change | Geometric Coefficient of Variation 29.53 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Non HDL: change in week 52 (n=9,8,9,5) | 8.06 percentage change | Geometric Coefficient of Variation 21.42 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | HDL: Change in week 12 (n=10,11,10,5) | -14.13 percentage change | Geometric Coefficient of Variation 30.08 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Non HDL: change in week 12 (n=10,11,10,5) | -5.37 percentage change | Geometric Coefficient of Variation 39.61 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | HDL: change in week 24 (n=10,10,9,5) | -1.83 percentage change | Geometric Coefficient of Variation 31.36 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Non HDL: change in week 12 (n=10,11,10,5) | -7.72 percentage change | Geometric Coefficient of Variation 42.4 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | HDL: change in week 52 (n=9,8,9,5) | 8.11 percentage change | Geometric Coefficient of Variation 29.35 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | HDL: Change in week 12 (n=10,11,10,5) | 3.37 percentage change | Geometric Coefficient of Variation 24.75 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Non HDL: change in week 24 (n=10,10,9,5) | -25.22 percentage change | Geometric Coefficient of Variation 31.49 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Non HDL: change in week 52 (n=9,8,9,5) | -17.68 percentage change | Geometric Coefficient of Variation 42.65 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Non HDL: change in week 52 (n=9,8,9,5) | 45.25 percentage change | Geometric Coefficient of Variation 37.45 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Non HDL: change in week 12 (n=10,11,10,5) | 20.70 percentage change | Geometric Coefficient of Variation 34.18 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Non HDL: change in week 24 (n=10,10,9,5) | 7.17 percentage change | Geometric Coefficient of Variation 40.5 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | HDL: Change in week 12 (n=10,11,10,5) | -5.99 percentage change | Geometric Coefficient of Variation 22.19 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | HDL: change in week 24 (n=10,10,9,5) | 6.67 percentage change | Geometric Coefficient of Variation 22.19 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | HDL: change in week 52 (n=9,8,9,5) | -7.33 percentage change | Geometric Coefficient of Variation 27.63 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Non HDL: change in week 12 (n=10,11,10,5) | -10.57 percentage change | Geometric Coefficient of Variation 26.16 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | HDL: Change in week 12 (n=10,11,10,5) | -7.09 percentage change | Geometric Coefficient of Variation 27.11 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | HDL: change in week 52 (n=9,8,9,5) | -21.41 percentage change | Geometric Coefficient of Variation 22.91 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Non HDL: change in week 52 (n=9,8,9,5) | -6.09 percentage change | Geometric Coefficient of Variation 24.59 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | Non HDL: change in week 24 (n=10,10,9,5) | -14.01 percentage change | Geometric Coefficient of Variation 28.04 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks | HDL: change in week 24 (n=10,10,9,5) | -15.60 percentage change | Geometric Coefficient of Variation 37.69 |
Secondary
Changes From Baseline in Triglyceride Levels up to 52 Weeks
Blood samples were collected for a fasting lipid panel, including total triglycerides. Lipid measurements were collected after a 12 hour (overnight) fast. The maintenance of effect was assessed on triglyceride levels during continued therapy with LCQ908 for up to 52 weeks. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)\*100.
Time frame: Baseline, Week 12, 24 and 52
Population: Full analysis set (FAS) - All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Triglyceride Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | -14.59 percentage change | Geometric Coefficient of Variation 52.33 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Triglyceride Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | 1.63 percentage change | Geometric Coefficient of Variation 45.19 |
| Placebo of Pradigastat (LCQ908) Regimen | Changes From Baseline in Triglyceride Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | 16.46 percentage change | Geometric Coefficient of Variation 29.27 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Triglyceride Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | -5.80 percentage change | Geometric Coefficient of Variation 66.1 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Triglyceride Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | -36.19 percentage change | Geometric Coefficient of Variation 64.8 |
| 20 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Triglyceride Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | -30.03 percentage change | Geometric Coefficient of Variation 78.52 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Triglyceride Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | 32.54 percentage change | Geometric Coefficient of Variation 87.83 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Triglyceride Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | 92.15 percentage change | Geometric Coefficient of Variation 60.21 |
| 40 mg Pradigastat (LCQ908) Regimen | Changes From Baseline in Triglyceride Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | 43.94 percentage change | Geometric Coefficient of Variation 52.66 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Triglyceride Levels up to 52 Weeks | change in week 24 (n=10,10,9,5) | -26.05 percentage change | Geometric Coefficient of Variation 31.5 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Triglyceride Levels up to 52 Weeks | Change in week 12 (n=10,11,10,5) | -19.36 percentage change | Geometric Coefficient of Variation 42.82 |
| Pradigastat (LCQ908) Regimen- From Study A2212 | Changes From Baseline in Triglyceride Levels up to 52 Weeks | change in week 52 (n=9,8,9,5) | -9.20 percentage change | Geometric Coefficient of Variation 43.34 |