Trial Outcomes & Findings for Study of Gemcabene in Adults With FPLD (NCT NCT03508687)
NCT ID: NCT03508687
Last Updated: 2020-08-17
Results Overview
This is measured by percent change in fasting serum triglyceride from baseline to week 12
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Baseline to week 12
Results posted on
2020-08-17
Participant Flow
Participant milestones
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Gemcabene in Adults With FPLD
Baseline characteristics by cohort
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
56 years
n=5 Participants
|
52 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Fasting Serum Triglycerides
|
283 mg/dL
n=5 Participants
|
790 mg/dL
n=7 Participants
|
587 mg/dL
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 12This is measured by percent change in fasting serum triglyceride from baseline to week 12
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Change in Fasting Serum Triglyceride (at 12 Weeks)
|
-0.44 percent change
Interval -41.27 to 40.38
|
-20.27 percent change
Interval -53.98 to 12.77
|
SECONDARY outcome
Timeframe: Baseline, week 6 and week 12, week 24This is measured by change in fasting serum triglyceride from baseline to average of weeks 6 and 12, and week 24 and change in fasting serum triglyceride from baseline to week 12
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Change in Fasting Serum Triglycerides (Through 24 Weeks)
Baseline to average of W6, W12, W24
|
9.25 mg/dL
Interval -68.5 to 87.0
|
-126.22 mg/dL
Interval -252.17 to -10.5
|
|
Change in Fasting Serum Triglycerides (Through 24 Weeks)
Baseline to W12
|
-10.75 mg/dL
Interval -126.5 to 105.0
|
-189.33 mg/dL
Interval -305.0 to 32.5
|
SECONDARY outcome
Timeframe: Baseline, week 6 and week 12, week 24This is measured by percent change in fasting serum triglyceride from baseline to average of weeks 6 and 12, and week 24 and change in fasting serum triglyceride from baseline to week 12
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Percent Change in Fasting Serum Triglycerides (Through 24 Weeks)
Baseline to Week 12
|
-0.44 percent change
Interval -41.27 to 40.38
|
-19.91 percent change
Interval -52.91 to 12.77
|
|
Percent Change in Fasting Serum Triglycerides (Through 24 Weeks)
Baseline to average of W6, W12, and W24
|
5.56 percent change
Interval -22.35 to 33.46
|
-18.91 percent change
Interval -45.15 to -4.15
|
SECONDARY outcome
Timeframe: Baseline, week 12, week 24This is measured by change in liver fat content using Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) from baseline to week 12 and week 24
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF)
Baseline to Week 12
|
2.71 % PDFF
Interval 0.37 to 5.05
|
1.01 % PDFF
Interval -4.22 to 7.76
|
|
Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF)
Baseline to Week 24
|
12.75 % PDFF
Interval 9.53 to 15.96
|
-1.27 % PDFF
Interval -8.54 to 8.2
|
SECONDARY outcome
Timeframe: Baseline, week 12, week 24This is measured by percent change in liver fat content using Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) from baseline to week 12 and week 24
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Percent Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF)
Baseline to Week 24
|
104.88 percent change in liver fat
Interval 54.21 to 155.56
|
-3.36 percent change in liver fat
Interval -64.21 to 73.15
|
|
Percent Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF)
Baseline to Week 12
|
25.66 percent change in liver fat
Interval 2.1 to 49.22
|
11.57 percent change in liver fat
Interval -31.73 to 69.22
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: Percentage of change in Preliminary Hepatic Fat-Fraction (PDFF)
This is measured by change in liver fibrosis using MR-elastography from baseline to week 12 and week 24
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Change in Liver Fibrosis
Baseline to Week 12
|
-0.63 kPA
Interval -0.63 to -0.63
|
0.96 kPA
Interval -0.05 to 1.73
|
|
Change in Liver Fibrosis
Baseline to Week 24
|
-0.03 kPA
Interval -0.45 to 0.39
|
.45 kPA
Interval 0.07 to 2.47
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24This is measured by percent change in liver fibrosis using MR-elastography from baseline to week 12 and week 24
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Percent Change in Liver Fibrosis
Baseline to Week 12
|
-19.07 percent change in fibrosis
Interval -19.87 to -18.26
|
27.84 percent change in fibrosis
Interval -2.04 to 62.1
|
|
Percent Change in Liver Fibrosis
Baseline to Week 24
|
-0.37 percent change in fibrosis
Interval -13.04 to 12.3
|
41.55 percent change in fibrosis
Interval 2.86 to 88.53
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: Liver biopsy was performed in two participants at baseline (1 subject in group-1 and another subject in group-2). Paired liver biopsy was only available for the subject in group-1.
This is measured by change in NAS via non-alcoholic fatty liver disease activity score. NAS is the unweighted sum of steatosis, lobular inflammation and hepatocyte ballooning from baseline to week 24. Total NAS scores can range from 0 to 8. The higher the NAS score, the more severe the liver disease.
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=1 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=1 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Change in NAS (Non-alcoholic Steatohepatitis)
|
2 scores on a scale (NAFLD activity score)
Interval 2.0 to 2.0
|
NA scores on a scale (NAFLD activity score)
Paired liver biopsy was not available for the subject in this group, week 24 data was not collected.
|
SECONDARY outcome
Timeframe: Baseline to week 24This is measured by change in NAS via non-alcoholic fatty liver disease activity score. NAS is the unweighted sum of steatosis, lobular inflammation and hepatocyte ballooning from baseline to week 24. Total NAS scores can range from 0 to 8. The higher the NAS score, the more severe the liver disease.
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=1 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=1 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Percent Change in NAS (Non-alcoholic Steatohepatitis)
|
100 percent change
Interval 100.0 to 100.0
|
NA percent change
Paired liver biopsy was not available for the subject in this group. Subject 602-007 (group-2): Baseline NAS = 3, week 24 not available.
|
SECONDARY outcome
Timeframe: Baseline, week 6 and week 12, week 24This will be measured by change in total, HDL and LDL levels in mg/dL
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Change in Cholesterol
Total Cholesterol Baseline to Week 12
|
-7.00 mg/dL
Interval -24.0 to 10.0
|
-16.67 mg/dL
Interval -39.0 to 0.0
|
|
Change in Cholesterol
Total Cholesterol Baseline to Week 24
|
20.50 mg/dL
Interval 13.0 to 28.0
|
23.67 mg/dL
Interval -19.0 to 82.0
|
SECONDARY outcome
Timeframe: Baseline, week 6 and week 12, week 24This will be measured as percent change in total, HDL and LDL levels in mg/dL.
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Percent Change in Cholesterol
Total Cholesterol Baseline to Week 12
|
-4.08 percent change
Interval -14.16 to 6.29
|
-7.61 percent change
Interval -19.21 to 0.0
|
|
Percent Change in Cholesterol
Total Cholesterol Baseline to Week 24
|
12.52 percent change
Interval 8.18 to 16.87
|
6.73 percent change
Interval -10.73 to 26.97
|
SECONDARY outcome
Timeframe: Baseline, week 6 and week 12, week 24This will be measured by change in apolipoprotein A and B in mg/dL
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Change in Apolipoprotein
Apolipoprotein B Baseline to Week 12
|
-4.35 mg/dL
Interval -17.02 to 8.33
|
-8.76 mg/dL
Interval -27.0 to 5.29
|
|
Change in Apolipoprotein
Apolipoprotein B Baseline to Week 24
|
6.74 mg/dL
Interval -5.73 to 19.22
|
7.57 mg/dL
Interval -13.89 to 31.47
|
SECONDARY outcome
Timeframe: Baseline, week 6 and week 12, week 24Population: % Change in participants in group A and group B
This will be measured by percent change in apolipoprotein A and B in mg/dL
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Percent Change in Apolipoprotein
Apolipoprotein B Baseline to Week 12
|
-5.38 percent change
Interval -21.33 to 10.57
|
-6.04 percent change
Interval -19.9 to 4.79
|
|
Percent Change in Apolipoprotein
Apolipoprotein B Baseline to Week 24
|
8.60 percent change
Interval -7.18 to 24.38
|
5.02 percent change
Interval -10.24 to 20.66
|
SECONDARY outcome
Timeframe: Baseline, week 12, week 24This is measured by change in high-sensitivity C-reactive protein (hsCRP) from baseline to weeks 12 and week 24
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Change in High-Sensitivity C-Reactive Protein (hsCRP)
hsCRP Baseline to Week 12
|
-0.70 mg/dL
Interval -1.3 to -0.1
|
-0.33 mg/dL
Interval -2.4 to 0.8
|
|
Change in High-Sensitivity C-Reactive Protein (hsCRP)
hsCRP Baseline to Week 24
|
0.15 mg/dL
Interval 0.1 to 0.2
|
0.77 mg/dL
Interval -2.0 to 2.9
|
SECONDARY outcome
Timeframe: Baseline, week 12, week 24This is measured by percent change in high-sensitivity C-reactive protein (hsCRP) from baseline to weeks 12 and week 24
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Percent Change in High-Sensitivity C-Reactive Protein (hsCRP)
hsCRP Baseline to W12
|
-42.36 percent change
Interval -72.22 to -12.5
|
3.71 percent change
Interval -63.16 to 57.14
|
|
Percent Change in High-Sensitivity C-Reactive Protein (hsCRP)
hsCRP Baseline to W24
|
15.28 percent change
Interval 5.56 to 25.0
|
43.41 percent change
Interval -52.63 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, week 12, week 24This is measured by change in alanine aminotransferase (ALT) from baseline to weeks 12 and week 24
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Change in Alanine Aminotransferase (ALT)
ALT Baseline to Week 12
|
2.50 IU/L
Interval 1.0 to 4.0
|
13.33 IU/L
Interval -13.0 to 41.0
|
|
Change in Alanine Aminotransferase (ALT)
ALT Baseline to Week 24
|
22.50 IU/L
Interval 14.0 to 31.0
|
40.67 IU/L
Interval -11.0 to 89.0
|
SECONDARY outcome
Timeframe: Baseline, week 12, week 24This is measured by percent change in alanine aminotransferase (ALT) from baseline to weeks 12 and week 24
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Percent Change in Alanine Aminotransferase (ALT)
ALT Baseline to W12
|
6.32 percent change
Interval 3.13 to 9.52
|
40.10 percent change
Interval -38.24 to 141.38
|
|
Percent Change in Alanine Aminotransferase (ALT)
ALT Baseline to W24
|
58.78 percent change
Interval 43.75 to 73.81
|
82.17 percent change
Interval -32.35 to 151.72
|
SECONDARY outcome
Timeframe: Baseline, week 12, week 24This is measured by change in aspartate aminotransferase (AST) from baseline to weeks 12 and week 24
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Change in Aspartate Aminotransferase (AST)
AST Baseline to Week 12
|
6.00 IU/L
Interval 2.0 to 10.0
|
8.00 IU/L
Interval -10.0 to 32.0
|
|
Change in Aspartate Aminotransferase (AST)
AST Baseline to Week 24
|
11.00 IU/L
Interval 4.0 to 18.0
|
62.67 IU/L
Interval -7.0 to 116.0
|
SECONDARY outcome
Timeframe: Baseline, week 12, week 24This is measured by percent change in aspartate aminotransferase (AST) from baseline to weeks 12 and week 24
Outcome measures
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 Participants
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Percent Change in Aspartate Aminotransferase (AST)
AST Baseline to W12
|
19.25 percent change
Interval 9.09 to 29.41
|
25.44 percent change
Interval -33.33 to 106.67
|
|
Percent Change in Aspartate Aminotransferase (AST)
AST Baseline to W24
|
35.56 percent change
Interval 18.18 to 52.94
|
160.41 percent change
Interval -23.33 to 386.67
|
Adverse Events
Group 1: 300 mg Gemcabene Daily Week 1-24
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2: 600mg Gemcabene Daily Week 12-24
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 participants at risk
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 participants at risk
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Nervous system disorders
Vertigo
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
Other adverse events
| Measure |
Group 1: 300 mg Gemcabene Daily Week 1-24
n=2 participants at risk
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.
300mg Gemcabene: 300mg Gemcabene
|
Group 2: 600mg Gemcabene Daily Week 12-24
n=3 participants at risk
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.
600mg Gemcabene: 600mg Gemcabene
|
|---|---|---|
|
Hepatobiliary disorders
Increase in liver fat
|
100.0%
2/2 • Number of events 2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Infections and infestations
Upper Respiratory Infection
|
50.0%
1/2 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Musculoskeletal and connective tissue disorders
Increased Muscle Pain
|
50.0%
1/2 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
0.00%
0/3 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Musculoskeletal and connective tissue disorders
Arthritis of thumb
|
50.0%
1/2 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
0.00%
0/3 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Gastrointestinal disorders
Bloating
|
50.0%
1/2 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
0.00%
0/3 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Infections and infestations
Cellulitis on R finger
|
50.0%
1/2 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
0.00%
0/3 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Psychiatric disorders
Depression
|
50.0%
1/2 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
0.00%
0/3 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
0.00%
0/3 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Musculoskeletal and connective tissue disorders
Increase in Creatinine Phosphokinase
|
50.0%
1/2 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
0.00%
0/3 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Metabolism and nutrition disorders
Increased Hunger
|
50.0%
1/2 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Vascular disorders
Increased Hypertension
|
50.0%
1/2 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
0.00%
0/3 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Renal and urinary disorders
Kidney Stones
|
50.0%
1/2 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Injury, poisoning and procedural complications
Pain from Liver Bx
|
50.0%
1/2 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
0.00%
0/3 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Cardiac disorders
Palpitations
|
50.0%
1/2 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
0.00%
0/3 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Infections and infestations
Sore Throat
|
50.0%
1/2 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
0.00%
0/3 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
General disorders
Body Pain
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Renal and urinary disorders
Decreased EGFR non-black
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Nervous system disorders
dizzyness 'spell' has history of these last episode ago 1 year
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Skin and subcutaneous tissue disorders
Dry skin itchniness
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Injury, poisoning and procedural complications
Fall down steps
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Nervous system disorders
Headache (migraine)
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Infections and infestations
HSV Outbreak
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Endocrine disorders
hypoglycemia
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Endocrine disorders
increase in calcium level (lab)
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
General disorders
Increase in fatigue
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Endocrine disorders
Increased Blood Sugars
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Renal and urinary disorders
Increased Creatinine
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
66.7%
2/3 • Number of events 2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Immune system disorders
increased CRP
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Nervous system disorders
Increased diabetic neuropathy
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
66.7%
2/3 • Number of events 2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Hepatobiliary disorders
Increased GGTP
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
66.7%
2/3 • Number of events 2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Nervous system disorders
Increased headaches
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Hepatobiliary disorders
increased liver enzymes
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
66.7%
2/3 • Number of events 3 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Musculoskeletal and connective tissue disorders
increased pain hips (arthritis)
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
General disorders
Increased stress levels
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Investigations
Lesion L side of mouth
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Musculoskeletal and connective tissue disorders
Pain increased knees both (arthritis bath)
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Musculoskeletal and connective tissue disorders
Shoulder soreness/stiffness
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
General disorders
upper right quadrant pain of abdomen
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Gastrointestinal disorders
vomited (intermittent)
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
|
Metabolism and nutrition disorders
weight loss
|
0.00%
0/2 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
33.3%
1/3 • Number of events 1 • 28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place