Trial Outcomes & Findings for A Study to Evaluate LTI-03 in Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) Patients (NCT NCT05954988)
NCT ID: NCT05954988
Last Updated: 2025-07-31
Results Overview
Incidence of TEAEs by dose
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
21 days (dosing x 14 days; follow up x 7 days)
Results posted on
2025-07-31
Participant Flow
Participant milestones
| Measure |
2.5 mg LTI-03 BID
2.5 mg LTI-03 BID x 14 days
LTI-03: Caveolin-1-Scaffolding-Protein-Derived Peptide
|
5 mg LTI-03 BID
5 mg LTI-03 BID x 14 days
LTI-03: Caveolin-1-Scaffolding-Protein-Derived Peptide
|
Placebo
Matching placebo BID x 14 days
Placebo: Matching placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
6
|
|
Overall Study
COMPLETED
|
9
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate LTI-03 in Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) Patients
Baseline characteristics by cohort
| Measure |
2.5 mg LTI-03 BID
n=9 Participants
2.5 mg LTI-03 BID x 14 days
LTI-03: Caveolin-1-Scaffolding-Protein-Derived Peptide
|
5 mg LTI-03 BID
n=9 Participants
5 mg LTI-03 BID x 14 days
LTI-03: Caveolin-1-Scaffolding-Protein-Derived Peptide
|
Placebo
n=6 Participants
Matching placebo BID x 14 days
Placebo: Matching placebo
|
Total
n=24 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 10.79 • n=7 Participants
|
71.7 years
STANDARD_DEVIATION 6.15 • n=5 Participants
|
69.0 years
STANDARD_DEVIATION 9.19 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Height
|
170.93 cm
STANDARD_DEVIATION 9.270 • n=5 Participants
|
169.56 cm
STANDARD_DEVIATION 9.530 • n=7 Participants
|
177.17 cm
STANDARD_DEVIATION 7.111 • n=5 Participants
|
171.98 cm
STANDARD_DEVIATION 9.067 • n=4 Participants
|
|
Weight
|
84.49 kg
STANDARD_DEVIATION 11.709 • n=5 Participants
|
85.36 kg
STANDARD_DEVIATION 25.108 • n=7 Participants
|
91.45 kg
STANDARD_DEVIATION 11.529 • n=5 Participants
|
86.55 kg
STANDARD_DEVIATION 17.446 • n=4 Participants
|
|
BMI
|
28.869 kg/m^2
STANDARD_DEVIATION 2.7335 • n=5 Participants
|
29.364 kg/m^2
STANDARD_DEVIATION 6.6335 • n=7 Participants
|
29.330 kg/m^2
STANDARD_DEVIATION 4.9868 • n=5 Participants
|
29.170 kg/m^2
STANDARD_DEVIATION 4.8340 • n=4 Participants
|
|
Number of Participants with Past and/or current tobacco use
Yes
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Number of Participants with Past and/or current tobacco use
No
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Cigarette smoking
|
18.25 pack-years
STANDARD_DEVIATION 10.327 • n=5 Participants
|
35.99 pack-years
STANDARD_DEVIATION 22.861 • n=7 Participants
|
26.88 pack-years
STANDARD_DEVIATION 26.772 • n=5 Participants
|
27.06 pack-years
STANDARD_DEVIATION 20.331 • n=4 Participants
|
|
Diffusion capacity of the lungs for carbon monoxide (DLCO)
|
5.123 mmol/min/kPa
STANDARD_DEVIATION 0.7913 • n=5 Participants
|
5.020 mmol/min/kPa
STANDARD_DEVIATION 1.5804 • n=7 Participants
|
5.354 mmol/min/kPa
STANDARD_DEVIATION 0.6776 • n=5 Participants
|
5.143 mmol/min/kPa
STANDARD_DEVIATION 1.1092 • n=4 Participants
|
|
Forced Vital Capacity (FVC)
|
3.214 L
STANDARD_DEVIATION 0.7744 • n=5 Participants
|
3.318 L
STANDARD_DEVIATION 0.6421 • n=7 Participants
|
3.085 L
STANDARD_DEVIATION 0.2733 • n=5 Participants
|
3.221 L
STANDARD_DEVIATION 0.6138 • n=4 Participants
|
|
FVC percent predicted
|
84.789 percent
STANDARD_DEVIATION 10.2189 • n=5 Participants
|
92.111 percent
STANDARD_DEVIATION 18.6644 • n=7 Participants
|
75.617 percent
STANDARD_DEVIATION 8.9410 • n=5 Participants
|
85.242 percent
STANDARD_DEVIATION 14.7507 • n=4 Participants
|
|
Leicester Cough Questionnaire (LCQ) Total Score
|
18.19 units on a scale
STANDARD_DEVIATION 3.264 • n=5 Participants
|
16.59 units on a scale
STANDARD_DEVIATION 3.236 • n=7 Participants
|
16.12 units on a scale
STANDARD_DEVIATION 3.373 • n=5 Participants
|
17.07 units on a scale
STANDARD_DEVIATION 3.262 • n=4 Participants
|
|
Cough Visual Analogue Scale (VAS) Score
|
29.6 units on a scale
STANDARD_DEVIATION 30.65 • n=5 Participants
|
38.1 units on a scale
STANDARD_DEVIATION 21.51 • n=7 Participants
|
35.3 units on a scale
STANDARD_DEVIATION 27.20 • n=5 Participants
|
34.2 units on a scale
STANDARD_DEVIATION 25.75 • n=4 Participants
|
PRIMARY outcome
Timeframe: 21 days (dosing x 14 days; follow up x 7 days)Incidence of TEAEs by dose
Outcome measures
| Measure |
2.5 mg LTI-03 BID
n=9 Participants
2.5 mg LTI-03 BID x 14 days
LTI-03: Caveolin-1-Scaffolding-Protein-Derived Peptide
|
5 mg LTI-03 BID
n=9 Participants
5 mg LTI-03 BID x 14 days
LTI-03: Caveolin-1-Scaffolding-Protein-Derived Peptide
|
Placebo
n=6 Participants
Matching placebo BID x 14 days
Placebo: Matching placebo
|
|---|---|---|---|
|
Incidence of Treatment-emergent Adverse Events (TEAEs)
Any serious TEAE
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs)
Any TEAE
|
66.7 percentage of participants
|
77.8 percentage of participants
|
50.0 percentage of participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs)
Any TEAE with CTCAE severity Grade 3 or higher
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs)
Any study drug-related TEAE
|
22.2 percentage of participants
|
55.6 percentage of participants
|
16.7 percentage of participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs)
Any TEAE leading to treatment discontinuation
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Incidence of Treatment-emergent Adverse Events (TEAEs)
Any TEAE leading to death
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
2.5 mg LTI-03 BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
5 mg LTI-03 BID
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2.5 mg LTI-03 BID
n=9 participants at risk
2.5 mg LTI-03 BID x 14 days
LTI-03: Caveolin-1-Scaffolding-Protein-Derived Peptide
|
5 mg LTI-03 BID
n=9 participants at risk
5 mg LTI-03 BID x 14 days
LTI-03: Caveolin-1-Scaffolding-Protein-Derived Peptide
|
Placebo
n=6 participants at risk
Matching placebo BID x 14 days
Placebo: Matching placebo
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Post-procedural fever
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
Other adverse events
| Measure |
2.5 mg LTI-03 BID
n=9 participants at risk
2.5 mg LTI-03 BID x 14 days
LTI-03: Caveolin-1-Scaffolding-Protein-Derived Peptide
|
5 mg LTI-03 BID
n=9 participants at risk
5 mg LTI-03 BID x 14 days
LTI-03: Caveolin-1-Scaffolding-Protein-Derived Peptide
|
Placebo
n=6 participants at risk
Matching placebo BID x 14 days
Placebo: Matching placebo
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
16.7%
1/6 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Nervous system disorders
Dysgeusia
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Nervous system disorders
Ophthalmic migraine
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
General disorders
Chest discomfort
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Gastrointestinal disorders
Hypoesthesia oral
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Gastrointestinal disorders
Esophageal spasm
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
16.7%
1/6 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
3/9 • Number of events 3 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
55.6%
5/9 • Number of events 5 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
33.3%
2/6 • Number of events 2 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Infections and infestations
COVID-19
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.1%
1/9 • Number of events 1 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/9 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
0.00%
0/6 • From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place