Trial Outcomes & Findings for A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia (NCT NCT03381287)
NCT ID: NCT03381287
Last Updated: 2023-03-03
Results Overview
TEAEs are defined as any AEs that commenced on or after exposure to study drug or any pre-existing AE that worsened in either intensity or frequency after exposure to study drug.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
4 weeks
Results posted on
2023-03-03
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
|
HTD1801 250 mg BID
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
|
HTD1801 500 mg BID
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
|
HTD1801 1000 mg BID
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
14
|
|
Overall Study
COMPLETED
|
12
|
11
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
|
HTD1801 250 mg BID
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
|
HTD1801 500 mg BID
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
|
HTD1801 1000 mg BID
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
|
HTD1801 250 mg BID
n=12 Participants
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
|
HTD1801 500 mg BID
n=12 Participants
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000mg: 1000 mg/day (500 mg BID)
|
HTD1801 1000 mg BID
n=14 Participants
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.4 years
n=99 Participants
|
48.4 years
n=107 Participants
|
54.3 years
n=206 Participants
|
52.0 years
n=7 Participants
|
52.0 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 4 weeksTEAEs are defined as any AEs that commenced on or after exposure to study drug or any pre-existing AE that worsened in either intensity or frequency after exposure to study drug.
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
|
HTD1801 250 mg BID
n=12 Participants
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
|
HTD1801 500 mg BID
n=12 Participants
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
|
HTD1801 1000 mg BID
n=14 Participants
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
|
|---|---|---|---|---|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
TEAE
|
8 Participants
|
10 Participants
|
8 Participants
|
11 Participants
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Severe TEAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Drug-related TEAEs
|
4 Participants
|
2 Participants
|
7 Participants
|
6 Participants
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
TEAEs leading to treatment interrupted or discontinued
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1Population: Specific PK samples were excluded from the PK analysis dataset as they were identified to have outside the established stability range for frozen sample storage.
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
|
HTD1801 250 mg BID
n=12 Participants
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
|
HTD1801 500 mg BID
n=14 Participants
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
|
HTD1801 1000 mg BID
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of HTD1801 Components After Single-dose Oral Administration
Berberine (BBR)
|
0.390 ng/mL
Standard Deviation 0.163
|
0.441 ng/mL
Standard Deviation 0.286
|
0.865 ng/mL
Standard Deviation 0.451
|
—
|
|
Maximum Plasma Concentration (Cmax) of HTD1801 Components After Single-dose Oral Administration
Ursodeoxycholic Acid (UDCA)
|
923 ng/mL
Standard Deviation 453
|
1900 ng/mL
Standard Deviation 847
|
2900 ng/mL
Standard Deviation 1520
|
—
|
SECONDARY outcome
Timeframe: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28Population: Specific PK samples were excluded from the PK analysis dataset as they were identified to have outside the established stability range for frozen sample storage.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
|
HTD1801 250 mg BID
n=12 Participants
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
|
HTD1801 500 mg BID
n=12 Participants
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
|
HTD1801 1000 mg BID
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of HTD1801 Components After Multiple-dose Oral Administration
Berberine (BBR)
|
0.676 ng/mL
Standard Deviation 0.231
|
1.510 ng/mL
Standard Deviation 1.200
|
1.770 ng/mL
Standard Deviation 1.310
|
—
|
|
Maximum Plasma Concentration (Cmax) of HTD1801 Components After Multiple-dose Oral Administration
Ursodeoxycholic Acid (UDCA)
|
962 ng/mL
Standard Deviation 275
|
1900 ng/mL
Standard Deviation 825
|
3370 ng/mL
Standard Deviation 966
|
—
|
SECONDARY outcome
Timeframe: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1Population: Specific PK samples were excluded from the PK analysis dataset as they were identified to have outside the established stability range for frozen sample storage.
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
|
HTD1801 250 mg BID
n=12 Participants
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
|
HTD1801 500 mg BID
n=14 Participants
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
|
HTD1801 1000 mg BID
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
|
|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Single-dose Oral Administration
Berberine (BBR)
|
3.5 hours
Interval 2.0 to 8.25
|
4.0 hours
Interval 2.0 to 8.0
|
4.0 hours
Interval 3.0 to 12.0
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Single-dose Oral Administration
Ursodeoxycholic Acid (UDCA)
|
2.0 hours
Interval 0.5 to 4.0
|
3.0 hours
Interval 1.0 to 4.07
|
4.0 hours
Interval 1.0 to 8.0
|
—
|
SECONDARY outcome
Timeframe: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28Population: Specific PK samples were excluded from the PK analysis dataset as they were identified to have outside the established stability range for frozen sample storage.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
|
HTD1801 250 mg BID
n=12 Participants
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
|
HTD1801 500 mg BID
n=12 Participants
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
|
HTD1801 1000 mg BID
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
|
|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Multiple-dose Oral Administration
Berberine (BBR)
|
4.0 hours
Interval 0.0 to 4.0
|
4.0 hours
Interval 0.25 to 12.0
|
4.0 hours
Interval 2.0 to 12.0
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Multiple-dose Oral Administration
Ursodeoxycholic Acid (UDCA)
|
3.0 hours
Interval 2.0 to 12.0
|
4.0 hours
Interval 2.0 to 8.0
|
3.0 hours
Interval 0.0 to 4.03
|
—
|
SECONDARY outcome
Timeframe: 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1Population: Specific PK samples were excluded from the PK analysis dataset as they were identified to have outside the established stability range for frozen sample storage.
Outcome measures
| Measure |
Placebo
n=5 Participants
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
|
HTD1801 250 mg BID
n=3 Participants
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
|
HTD1801 500 mg BID
n=3 Participants
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
|
HTD1801 1000 mg BID
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
|
|---|---|---|---|---|
|
Plasma Half-life of HTD1801 Components (T1/2) After Single-dose Oral Administration
Ursodeoxycholic Acid (UDCA)
|
2.79 hours
Standard Deviation 0.92
|
8.43 hours
Standard Deviation 11.30
|
5.24 hours
Standard Deviation 1.64
|
—
|
|
Plasma Half-life of HTD1801 Components (T1/2) After Single-dose Oral Administration
Berberine (BBR)
|
9.04 hours
Standard Deviation 1.50
|
10.60 hours
Standard Deviation 2.51
|
7.79 hours
Standard Deviation 0.60
|
—
|
SECONDARY outcome
Timeframe: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28Population: Specific PK samples were excluded from the PK analysis dataset as they were identified to have outside the established stability range for frozen sample storage.
Outcome measures
| Measure |
Placebo
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
|
HTD1801 250 mg BID
n=3 Participants
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
|
HTD1801 500 mg BID
n=4 Participants
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
|
HTD1801 1000 mg BID
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
|
|---|---|---|---|---|
|
Plasma Half-life of HTD1801 Components (T1/2) After Multiple-dose Oral Administration
Ursodeoxycholic Acid (UDCA)
|
—
|
7.60 hours
Standard Deviation 2.90
|
7.53 hours
Standard Deviation 2.78
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 28Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
|
HTD1801 250 mg BID
n=11 Participants
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
|
HTD1801 500 mg BID
n=11 Participants
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
|
HTD1801 1000 mg BID
n=12 Participants
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
|
|---|---|---|---|---|
|
Percent Change in Low-density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 28 Within and Between Treatment Groups
Percent Change from Baseline to Day 28
|
-3.585 percentage change from baseline
Standard Deviation 21.7628
|
-7.674 percentage change from baseline
Standard Deviation 13.1407
|
0.372 percentage change from baseline
Standard Deviation 15.3368
|
-9.767 percentage change from baseline
Standard Deviation 12.6763
|
|
Percent Change in Low-density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 28 Within and Between Treatment Groups
Percent Change from Baseline to Day 14
|
3.624 percentage change from baseline
Standard Deviation 11.9910
|
-3.390 percentage change from baseline
Standard Deviation 8.3100
|
-1.1550 percentage change from baseline
Standard Deviation 26.2682
|
-9.296 percentage change from baseline
Standard Deviation 14.9090
|
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 28Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
|
HTD1801 250 mg BID
n=12 Participants
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
|
HTD1801 500 mg BID
n=12 Participants
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
|
HTD1801 1000 mg BID
n=14 Participants
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
|
|---|---|---|---|---|
|
Percent Change in Triglycerides From Baseline to Day 28 Within and Between Treatment Groups
Percent Change from Baseline to Day 14
|
1.724 percentage change from baseline
Standard Deviation 19.4047
|
-5.788 percentage change from baseline
Standard Deviation 25.4470
|
12.798 percentage change from baseline
Standard Deviation 34.8867
|
-2.240 percentage change from baseline
Standard Deviation 28.2301
|
|
Percent Change in Triglycerides From Baseline to Day 28 Within and Between Treatment Groups
Percent Change from Baseline to Day 28
|
36.778 percentage change from baseline
Standard Deviation 30.1113
|
7.684 percentage change from baseline
Standard Deviation 27.8053
|
25.882 percentage change from baseline
Standard Deviation 34.6145
|
6.256 percentage change from baseline
Standard Deviation 18.4114
|
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 28Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
|
HTD1801 250 mg BID
n=5 Participants
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
|
HTD1801 500 mg BID
n=12 Participants
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
|
HTD1801 1000 mg BID
n=10 Participants
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
|
|---|---|---|---|---|
|
Percent Change in Free-fatty Acids (FFA) From Baseline to Day 28 Within and Between Treatment Groups
Percent Change from Baseline to Day 14
|
-41.743 percentage change from baseline
Standard Deviation 29.7652
|
-38.672 percentage change from baseline
Standard Deviation 37.1275
|
-41.295 percentage change from baseline
Standard Deviation 20.1601
|
-32.192 percentage change from baseline
Standard Deviation 28.0350
|
|
Percent Change in Free-fatty Acids (FFA) From Baseline to Day 28 Within and Between Treatment Groups
Percent Change from Baseline to Day 28
|
-33.153 percentage change from baseline
Standard Deviation 33.9741
|
-46.458 percentage change from baseline
Standard Deviation 36.1597
|
47.246 percentage change from baseline
Standard Deviation 18.0392
|
-34.382 percentage change from baseline
Standard Deviation 24.8417
|
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 28Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
|
HTD1801 250 mg BID
n=11 Participants
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
|
HTD1801 500 mg BID
n=8 Participants
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
|
HTD1801 1000 mg BID
n=12 Participants
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
|
|---|---|---|---|---|
|
Percent Change in Lipoprotein-A From Baseline to Day 28 Within and Between Treatment Groups
Percent Change from Baseline to Day 28
|
10.582 percentage change from baseline
Standard Deviation 20.4217
|
-11.239 percentage change from baseline
Standard Deviation 33.9248
|
242.570 percentage change from baseline
Standard Deviation 477.1207
|
-21.916 percentage change from baseline
Standard Deviation 26.2907
|
|
Percent Change in Lipoprotein-A From Baseline to Day 28 Within and Between Treatment Groups
Percent Change from Baseline to Day 14
|
-4.975 percentage change from baseline
Standard Deviation 27.7800
|
-19.527 percentage change from baseline
Standard Deviation 22.0535
|
222.4113 percentage change from baseline
Standard Deviation 214.9631
|
-13.034 percentage change from baseline
Standard Deviation 27.9322
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
HTD1801 250 mg BID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
HTD1801 500 mg BID
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
HTD1801 1000 mg BID
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=12 participants at risk
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet bid)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet bid)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet bid)
|
HTD1801 250 mg BID
n=12 participants at risk
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500mg: 500 mg/day (250 mg bid)
|
HTD1801 500 mg BID
n=12 participants at risk
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000mg: 1000 mg/day (500 mg bid)
|
HTD1801 1000 mg BID
n=14 participants at risk
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000mg: 2000 mg/day (1000 mg bid)
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Hepatobiliary disorders
Hepatitis.
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet bid)
Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet bid)
Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet bid)
|
HTD1801 250 mg BID
n=12 participants at risk
Subjects received 500 mg/day HTD1801
HTD1801 Tablets, 500mg: 500 mg/day (250 mg bid)
|
HTD1801 500 mg BID
n=12 participants at risk
Subjects received 1000 mg/day HTD1801
HTD1801 Tablets, 1000mg: 1000 mg/day (500 mg bid)
|
HTD1801 1000 mg BID
n=14 participants at risk
Subjects received 2000 mg/day HTD1801
HTD1801 Tablets, 2000mg: 2000 mg/day (1000 mg bid)
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Infections and infestations
Rhinitis
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
General disorders
Catheter site erythema
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
General disorders
Catheter site pain
|
8.3%
1/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
General disorders
Fatigue
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
General disorders
Malaise
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
General disorders
Ulcer
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
25.0%
3/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Nervous system disorders
Headache
|
41.7%
5/12 • 4 weeks
|
41.7%
5/12 • 4 weeks
|
33.3%
4/12 • 4 weeks
|
21.4%
3/14 • 4 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • 4 weeks
|
16.7%
2/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Nervous system disorders
Migraine
|
8.3%
1/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • 4 weeks
|
16.7%
2/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
2/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Vascular disorders
Haematoma
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Vascular disorders
Phlebitis
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Vascular disorders
Vascular pain
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/12 • 4 weeks
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Ear and labyrinth disorders
Vertigo positional
|
8.3%
1/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/12 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60