Trial Outcomes & Findings for Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension (NCT NCT05135000)
NCT ID: NCT05135000
Last Updated: 2026-01-13
Results Overview
PVR was defined as the resistance against blood flow from the pulmonary artery to the left atrium measured in dyn.s.cm-5
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Baseline, Week 25
Results posted on
2026-01-13
Participant Flow
A total of 56 participants were screened for the study. Out of these, 47 participants were randomized.
Participant milestones
| Measure |
LTP001
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
Placebo
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
12
|
|
Overall Study
COMPLETED
|
26
|
9
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
LTP001
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
Placebo
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
6
|
3
|
Baseline Characteristics
Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
LTP001
n=35 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
Placebo
n=12 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 Years
STANDARD_DEVIATION 13.03 • n=210 Participants
|
45.3 Years
STANDARD_DEVIATION 13.78 • n=19 Participants
|
45.3 Years
STANDARD_DEVIATION 13.07 • n=123 Participants
|
|
Age, Customized
18 - <65
|
32 Participants
n=210 Participants
|
11 Participants
n=19 Participants
|
43 Participants
n=123 Participants
|
|
Age, Customized
65 - <85
|
3 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
4 Participants
n=123 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=210 Participants
|
10 Participants
n=19 Participants
|
39 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
8 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=210 Participants
|
11 Participants
n=19 Participants
|
43 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska
|
2 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 25Population: The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.
PVR was defined as the resistance against blood flow from the pulmonary artery to the left atrium measured in dyn.s.cm-5
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=24 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Change From Baseline in Right Heard Catheterization Pulmonary Vascular Resistance (PVR) at Week 25
|
-49.685 dynes.sec.cm^-5
Standard Deviation 181.3745
|
-1.175 dynes.sec.cm^-5
Standard Deviation 254.0792
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13 and 25Population: The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.
6MWD test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=30 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Change From Baseline in Six Minute Walk Distance (6MWD)
Week 13 n=30,10
|
7.4 meters
Standard Deviation 29.34
|
3.2 meters
Standard Deviation 42.45
|
|
Change From Baseline in Six Minute Walk Distance (6MWD)
Week 25 n=28,10
|
21.0 meters
Standard Deviation 32.33
|
10.4 meters
Standard Deviation 44.36
|
SECONDARY outcome
Timeframe: Baseline, Week 25Population: The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.
The Right Heart Catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including RA pressures.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=26 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Change From Baseline in Right Atrium (RA) Pressures at Week 25
|
-0.6 mmHg
Standard Deviation 0.73
|
-0.4 mmHg
Standard Deviation 4.40
|
SECONDARY outcome
Timeframe: Baseline, Week 25Population: The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.
Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including pulmonary capillary wedge pressure (PCWP).
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=24 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure at Week 25
|
0.9 mmHg
Standard Deviation 2.26
|
0.2 mmHg
Standard Deviation 3.66
|
SECONDARY outcome
Timeframe: Baseline, Week 25Population: The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.
Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including pulmonary artery pressure.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=26 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Change From Baseline in Mean Pulmonary Artery Pressure at Week 25
|
-0.6 mmHg
Standard Deviation 5.61
|
0.4 mmHg
Standard Deviation 8.55
|
SECONDARY outcome
Timeframe: Baseline, Week 25Population: The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.
Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including cardiac output (CO).
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=26 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Change From Baseline in Average Cardiac Output (CO) at Week 25
|
0.493 liters per minute
Standard Deviation 0.9075
|
0.067 liters per minute
Standard Deviation 1.0772
|
SECONDARY outcome
Timeframe: Baseline, Weeks 5, 13, and 25Population: The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.
Key right ventricular (RV) function endpoints such as RV fractional area change (RV FAC) were assessed with echocardiography.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=31 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Change From Baseline in Fractional Area Change (FAC)
Week 13 n=29,10
|
2.62 percent
Standard Deviation 4.417
|
-1.19 percent
Standard Deviation 6.424
|
|
Change From Baseline in Fractional Area Change (FAC)
Week 25 n=26,8
|
-1.45 percent
Standard Deviation 7.532
|
-1.85 percent
Standard Deviation 5.412
|
|
Change From Baseline in Fractional Area Change (FAC)
Week 5 n=31,9
|
0.92 percent
Standard Deviation 5.622
|
0.35 percent
Standard Deviation 6.944
|
SECONDARY outcome
Timeframe: Baseline, Weeks 5, 13, and 25Population: The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.
Key right ventricular (RV) function per echocardiography. The terms Tricuspid Annular Systolic Velocity (TASV) and Peak Velocity of Excursion (RV S') are synonymous in echocardiography to describe the peak systolic velocity of the lateral tricuspid annulus. Including both TASV and RV S' as separate secondary endpoints was an oversight in the protocol as the data, calculation, and analyses for both (TASV and RV S') are identical. Therefore, the TASV and RV S' data in this results disclosure are the same.
Outcome measures
| Measure |
Placebo
n=11 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=33 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Change From Baseline in Peak Velocity of Excursion (RV S')
Week 5 n=33,11
|
-0.4 centimeters per second
Standard Deviation 1.50
|
0.2 centimeters per second
Standard Deviation 2.14
|
|
Change From Baseline in Peak Velocity of Excursion (RV S')
Week 13 n=32,11
|
-0.5 centimeters per second
Standard Deviation 1.63
|
-0.2 centimeters per second
Standard Deviation 2.38
|
|
Change From Baseline in Peak Velocity of Excursion (RV S')
Week 25 n=26,9
|
-1.0 centimeters per second
Standard Deviation 3.00
|
0.4 centimeters per second
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: Baseline, Weeks 5, 13, and 25Population: The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.
Key right ventricular (RV) function endpoints such as tricuspid annular plane systolic excursion (TAPSE) were assessed with echocardiography.
Outcome measures
| Measure |
Placebo
n=11 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=33 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Week 5 n=33,11
|
0.042 centimeters
Standard Deviation 0.3383
|
0.061 centimeters
Standard Deviation 0.3181
|
|
Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Week 13 n=31,11
|
0.100 centimeters
Standard Deviation 0.2933
|
-0.026 centimeters
Standard Deviation 0.2594
|
|
Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Week 25 n=27,9
|
-0.067 centimeters
Standard Deviation 0.2121
|
0.015 centimeters
Standard Deviation 0.3697
|
SECONDARY outcome
Timeframe: Baseline, Weeks 5, 13 and 25Population: The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.
Key right ventricular (RV) function endpoints such as tricuspid annular systolic velocity (TASV) were assessed with echocardiography.
Outcome measures
| Measure |
Placebo
n=11 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=33 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Change From Baseline in Tricuspid Annular Systolic Velocity (TASV)
Week 5 n=33,11
|
-0.4 centimeters per second
Standard Deviation 1.50
|
0.2 centimeters per second
Standard Deviation 2.14
|
|
Change From Baseline in Tricuspid Annular Systolic Velocity (TASV)
Week 13 n=32,11
|
-0.5 centimeters per second
Standard Deviation 1.63
|
-0.2 centimeters per second
Standard Deviation 2.38
|
|
Change From Baseline in Tricuspid Annular Systolic Velocity (TASV)
Week 25 n=26,9
|
-1.0 centimeters per second
Standard Deviation 3.00
|
0.4 centimeters per second
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13 and 25Population: The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.
emPHasis-10 is a questionnaire with 10 questions designed to determine how pulmonary hypertension affects a participant's life. Each item is scored on a scale of 0 to 5, with a total score ranging from 0 to 50. A higher score indicates worse quality of life.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=21 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Change From Baseline in EmPHasis-10
Week 13 n=21,9
|
-3.622 score
Standard Deviation 3.1712
|
-1.490 score
Standard Deviation 5.7108
|
|
Change From Baseline in EmPHasis-10
Week 25 n=17,9
|
-3.000 score
Standard Deviation 4.2961
|
-4.972 score
Standard Deviation 8.7643
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13 and 25Population: The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.
PAH-SYMPACT is a questionnaire used to assess pulmonary arterial hypertension symptoms and their impact. Individual item scores range from 0 to 4. Total score is calculated as the sum of the scores for the individual items divided by the number of items. A higher score indicates more severe symptoms/impacts.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=11 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Change From Baseline in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)
Week 13
|
-3.545 score
Standard Deviation 3.2693
|
-1.452 score
Standard Deviation 6.3897
|
|
Change From Baseline in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)
Week 25
|
-4.220 score
Standard Deviation 6.1990
|
-0.680 score
Standard Deviation 5.7304
|
SECONDARY outcome
Timeframe: Day 1 and Week 25 at 15, 45, and 120 minutes post-dosePopulation: The pharmacokinetic (PK) analysis set included all participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received any study drug, and without protocol deviations that impacted PK data.
The maximum (peak) observed blood drug concentration after single dose administration.
Outcome measures
| Measure |
Placebo
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=30 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Maximum Observed Blood Concentrations (Cmax) for LTP001
Day 1
|
—
|
38.6 ng/mL
Geometric Coefficient of Variation 58.2
|
|
Maximum Observed Blood Concentrations (Cmax) for LTP001
Week 25
|
—
|
39.2 ng/mL
Geometric Coefficient of Variation 54.7
|
SECONDARY outcome
Timeframe: Day 1 and Week 25 at 15, 45, and 120 minutes post-dosePopulation: The pharmacokinetic (PK) analysis set included all participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received any study drug, and without protocol deviations that impacted PK data.
The time to reach maximum (peak) blood drug concentration after single dose administration.
Outcome measures
| Measure |
Placebo
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=30 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Time to Reach Maximum Blood Concentrations (Tmax) of LTP001
Day 1
|
—
|
1.05 hours
Geometric Coefficient of Variation 56.6
|
|
Time to Reach Maximum Blood Concentrations (Tmax) of LTP001
Week 25
|
—
|
0.979 hours
Geometric Coefficient of Variation 68.8
|
SECONDARY outcome
Timeframe: Baseline up to approximately 30 weeksPopulation: The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data. Participants without the event were considered as censored at the end of the time at risk.
Time to any of the following: * Death * Hospital stay greater than 24 hours due to worsening of pulmonary arterial hypertension * Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy * Initiation of parenteral prostanoid therapy, initiation of oxygen therapy, initiation of any other pulmonary arterial hypertension-specific therapies or need for increase of diuretics for more than 4 weeks due to worsening of pulmonary arterial hypertension * Significant drop in six minute walk distance
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=34 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Time to Clinical Worsening
|
175.0 days
Interval 174.0 to
The upper limit of 95% CI was not calculable due to an insufficient number of participants with events.
|
211.0 days
Interval 174.0 to
The upper limit of 95% CI was not calculable due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline to Week 29Population: The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.
NT-proBNP is a blood biomarker to assess right ventricular distress.
Outcome measures
| Measure |
Placebo
n=11 Participants
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
LTP001
n=27 Participants
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
|---|---|---|
|
Change From Baseline in N-terminal Fragment of the Prohormone B-type Natriuretic Peptide (NT-ProBNP)
|
-7.918 picomoles per liter
Standard Deviation 21.9731
|
4.609 picomoles per liter
Standard Deviation 52.9047
|
Adverse Events
LTP001
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Total
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LTP001
n=35 participants at risk
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
Placebo
n=12 participants at risk
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
Total
n=47 participants at risk
Total
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
2.9%
1/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Cardiac disorders
Right ventricular failure
|
2.9%
1/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.9%
1/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Psychiatric disorders
Bipolar disorder
|
2.9%
1/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.9%
1/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
2.9%
1/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
Other adverse events
| Measure |
LTP001
n=35 participants at risk
Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
|
Placebo
n=12 participants at risk
Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
|
Total
n=47 participants at risk
Total
|
|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Endocrine disorders
Hyperthyroidism
|
5.7%
2/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
4.3%
2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
2/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
4.3%
2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Gastrointestinal disorders
Nausea
|
11.4%
4/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
10.6%
5/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
4.3%
2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
General disorders and administration site conditions
Asthenia
|
5.7%
2/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
4.3%
2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
General disorders and administration site conditions
Chest discomfort
|
0.00%
0/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Cardiac disorders
Palpitations
|
8.6%
3/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.5%
4/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
General disorders and administration site conditions
Fatigue
|
5.7%
2/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
6.4%
3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
General disorders and administration site conditions
Influenza like illness
|
2.9%
1/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
4.3%
2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
General disorders and administration site conditions
Peripheral swelling
|
5.7%
2/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
4.3%
2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Infections and infestations
COVID-19
|
0.00%
0/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Infections and infestations
Influenza
|
8.6%
3/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
6.4%
3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
2/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
4.3%
2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Infections and infestations
Respiratory tract infection
|
5.7%
2/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
4.3%
2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.6%
3/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
6.4%
3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
2/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
4.3%
2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
2/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
4.3%
2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Nervous system disorders
Headache
|
17.1%
6/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
12.8%
6/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Nervous system disorders
Presyncope
|
5.7%
2/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
6.4%
3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
2/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
6.4%
3/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
1/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
4.3%
2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
2/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
4.3%
2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
2.1%
1/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
|
Vascular disorders
Haematoma
|
5.7%
2/35 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
4.3%
2/47 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER