Trial Outcomes & Findings for LYT-100 in Post-acute COVID-19 Respiratory Disease (NCT NCT04652518)
NCT ID: NCT04652518
Last Updated: 2026-06-23
Results Overview
The 6MWT is a validated endpoint commonly used in clinical trial research. The 6MWT measures the distance a subject can quickly walk on a flat, hard surface in a period of 6 minutes. It evaluates the global and integrated response of all the systems involved during exercise.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
185 participants
Primary outcome timeframe
Baseline to Day 91
Results posted on
2026-06-23
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matching LYT-100 taken orally BID for 91 days
Placebo: oral administration
|
LYT-100
LYT-100 taken orally twice a day (BID) for 91 days
LYT-100: oral administration
|
|---|---|---|
|
Double-blind (Days 1 to 91)
STARTED
|
90
|
95
|
|
Double-blind (Days 1 to 91)
COMPLETED
|
77
|
73
|
|
Double-blind (Days 1 to 91)
NOT COMPLETED
|
13
|
22
|
|
Open-label Extension (Days 92 to 182)
STARTED
|
60
|
47
|
|
Open-label Extension (Days 92 to 182)
COMPLETED
|
41
|
29
|
|
Open-label Extension (Days 92 to 182)
NOT COMPLETED
|
19
|
18
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matching LYT-100 taken orally BID for 91 days
Placebo: oral administration
|
LYT-100
LYT-100 taken orally twice a day (BID) for 91 days
LYT-100: oral administration
|
|---|---|---|
|
Double-blind (Days 1 to 91)
Adverse Event
|
4
|
11
|
|
Double-blind (Days 1 to 91)
Lost to Follow-up
|
1
|
1
|
|
Double-blind (Days 1 to 91)
Physician Decision
|
0
|
1
|
|
Double-blind (Days 1 to 91)
Study terminated by Sponsor
|
1
|
3
|
|
Double-blind (Days 1 to 91)
Withdrawal by Subject
|
6
|
3
|
|
Double-blind (Days 1 to 91)
Other-Reason Not Available
|
1
|
3
|
|
Open-label Extension (Days 92 to 182)
Adverse Event
|
5
|
6
|
|
Open-label Extension (Days 92 to 182)
Lost to Follow-up
|
0
|
1
|
|
Open-label Extension (Days 92 to 182)
Study terminated by Sponsor
|
10
|
9
|
|
Open-label Extension (Days 92 to 182)
Withdrawal by Subject
|
0
|
2
|
|
Open-label Extension (Days 92 to 182)
Other - Reason Not Available
|
4
|
0
|
Baseline Characteristics
LYT-100 in Post-acute COVID-19 Respiratory Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=85 Participants
Placebo matching LYT-100 taken orally BID for 91 days
Placebo: oral administration
|
LYT-100
n=92 Participants
LYT-100 taken orally twice a day (BID) for 91 days
LYT-100: oral administration
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 12.49 • n=20 Participants
|
56.6 years
STANDARD_DEVIATION 12.14 • n=20 Participants
|
54.7 years
STANDARD_DEVIATION 12.43 • n=40 Participants
|
|
Age, Customized
<65 years
|
67 Participants
n=20 Participants
|
69 Participants
n=20 Participants
|
136 Participants
n=40 Participants
|
|
Age, Customized
>=65 years
|
18 Participants
n=20 Participants
|
23 Participants
n=20 Participants
|
41 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=20 Participants
|
32 Participants
n=20 Participants
|
67 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=20 Participants
|
60 Participants
n=20 Participants
|
110 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=20 Participants
|
82 Participants
n=20 Participants
|
158 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
30 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=20 Participants
|
79 Participants
n=20 Participants
|
140 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Region of Enrollment
Argentina
|
5 participants
n=20 Participants
|
8 participants
n=20 Participants
|
13 participants
n=40 Participants
|
|
Region of Enrollment
Romania
|
23 participants
n=20 Participants
|
25 participants
n=20 Participants
|
48 participants
n=40 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=20 Participants
|
17 participants
n=20 Participants
|
28 participants
n=40 Participants
|
|
Region of Enrollment
Philippines
|
17 participants
n=20 Participants
|
8 participants
n=20 Participants
|
25 participants
n=40 Participants
|
|
Region of Enrollment
Ukraine
|
14 participants
n=20 Participants
|
20 participants
n=20 Participants
|
34 participants
n=40 Participants
|
|
Region of Enrollment
Brazil
|
0 participants
n=20 Participants
|
2 participants
n=20 Participants
|
2 participants
n=40 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=20 Participants
|
2 participants
n=20 Participants
|
5 participants
n=40 Participants
|
|
Region of Enrollment
Moldova
|
12 participants
n=20 Participants
|
10 participants
n=20 Participants
|
22 participants
n=40 Participants
|
|
Weight
|
85.45 kg
STANDARD_DEVIATION 17.8 • n=20 Participants
|
87.82 kg
STANDARD_DEVIATION 16.99 • n=20 Participants
|
86.68 kg
STANDARD_DEVIATION 17.375 • n=40 Participants
|
|
Height
|
169.24 cm
STANDARD_DEVIATION 10.178 • n=20 Participants
|
170.68 cm
STANDARD_DEVIATION 9.858 • n=20 Participants
|
169.99 cm
STANDARD_DEVIATION 10.01 • n=40 Participants
|
|
BMI
|
29.73 kg/m^2
STANDARD_DEVIATION 5.176 • n=20 Participants
|
30.05 kg/m^2
STANDARD_DEVIATION 4.71 • n=20 Participants
|
29.89 kg/m^2
STANDARD_DEVIATION 4.928 • n=40 Participants
|
|
Days since discharge from hospital
|
34.2 days
STANDARD_DEVIATION 29.11 • n=20 Participants
|
34.3 days
STANDARD_DEVIATION 26.92 • n=20 Participants
|
34.3 days
STANDARD_DEVIATION 27.91 • n=40 Participants
|
|
Time from COVID diagnosis to first dose of study drug
|
58.1 days
STANDARD_DEVIATION 27.56 • n=20 Participants
|
56.3 days
STANDARD_DEVIATION 28.16 • n=20 Participants
|
57.1 days
STANDARD_DEVIATION 27.81 • n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 91Population: Analysis based on the Intent to Treat (ITT) Population which is different from the Safety Analysis Population presented in the Participants Flow section. See Statistical Analysis Plan (SAP).
The 6MWT is a validated endpoint commonly used in clinical trial research. The 6MWT measures the distance a subject can quickly walk on a flat, hard surface in a period of 6 minutes. It evaluates the global and integrated response of all the systems involved during exercise.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo matching LYT-100 taken orally BID for 91 days
Placebo: oral administration
|
LYT-100
n=92 Participants
LYT-100 taken orally twice a day (BID) for 91 days
LYT-100: oral administration
|
|---|---|---|
|
Change From Baseline in Distance Walked During the Six-Minute Walk Test (6MWT)
|
48.77 meters
Standard Error 9.997
|
44.28 meters
Standard Error 9.948
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 19 other events
Deaths: 1 deaths
LYT-100
Serious events: 3 serious events
Other events: 52 other events
Deaths: 0 deaths
Open Label Extension LYT-100
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=90 participants at risk
Placebo matching LYT-100 taken orally BID for 91 days
Placebo: oral administration
|
LYT-100
n=95 participants at risk
LYT-100 taken orally twice a day (BID) for 91 days
LYT-100: oral administration
|
Open Label Extension LYT-100
n=107 participants at risk
Open Label Extension: LYT-100 taken orally BID for 91 days The Open Label Extension (Part B) was terminated after results of the Double Blind Portion.
LYT-100: oral administration
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
1.1%
1/90 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.00%
0/95 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.00%
0/107 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.1%
1/90 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.00%
0/95 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.00%
0/107 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/90 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.00%
0/95 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.00%
0/107 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/90 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
1.1%
1/95 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.00%
0/107 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/90 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
1.1%
1/95 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.00%
0/107 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Nervous system disorders
Mixed dementia
|
0.00%
0/90 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
1.1%
1/95 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.00%
0/107 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Vascular disorders
Hypertension/
|
0.00%
0/90 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.00%
0/95 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.93%
1/107 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/90 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.00%
0/95 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.93%
1/107 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/90 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.00%
0/95 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.93%
1/107 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/90 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.00%
0/95 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.93%
1/107 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
Other adverse events
| Measure |
Placebo
n=90 participants at risk
Placebo matching LYT-100 taken orally BID for 91 days
Placebo: oral administration
|
LYT-100
n=95 participants at risk
LYT-100 taken orally twice a day (BID) for 91 days
LYT-100: oral administration
|
Open Label Extension LYT-100
n=107 participants at risk
Open Label Extension: LYT-100 taken orally BID for 91 days The Open Label Extension (Part B) was terminated after results of the Double Blind Portion.
LYT-100: oral administration
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|---|---|---|---|
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Gastrointestinal disorders
Nausea
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1.1%
1/90 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
9.5%
9/95 • Number of events 11 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
2.8%
3/107 • Number of events 3 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
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Gastrointestinal disorders
Abdominal Pain Upper
|
2.2%
2/90 • Number of events 2 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
5.3%
5/95 • Number of events 6 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
0.93%
1/107 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Gastrointestinal disorders
Dyspepsia
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1.1%
1/90 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
6.3%
6/95 • Number of events 6 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
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4.7%
5/107 • Number of events 5 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
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Infections and infestations
COVID-19
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2.2%
2/90 • Number of events 2 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
2.1%
2/95 • Number of events 2 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
3.7%
4/107 • Number of events 4 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
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Infections and infestations
Nasopharyngitis
|
1.1%
1/90 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
5.3%
5/95 • Number of events 6 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
2.8%
3/107 • Number of events 3 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Infections and infestations
Urinary Tract Infection
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1.1%
1/90 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
1.1%
1/95 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
3.7%
4/107 • Number of events 5 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Investigations
Fibrin D Dimer Increased
|
1.1%
1/90 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
5.3%
5/95 • Number of events 6 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
1.9%
2/107 • Number of events 2 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Investigations
Hepatic Enzyme Increased
|
2.2%
2/90 • Number of events 2 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
2.1%
2/95 • Number of events 3 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
3.7%
4/107 • Number of events 6 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.6%
5/90 • Number of events 5 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
3.2%
3/95 • Number of events 3 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
3.7%
4/107 • Number of events 4 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Nervous system disorders
Headache
|
2.2%
2/90 • Number of events 2 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
5.3%
5/95 • Number of events 5 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
2.8%
3/107 • Number of events 3 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/90 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
5.3%
5/95 • Number of events 6 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
3.7%
4/107 • Number of events 5 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/90 • Number of events 1 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
4.2%
4/95 • Number of events 4 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
|
3.7%
4/107 • Number of events 5 • Data for the Double-blind Part of the study was reported for Days 1 to 91. Data for the Open-label Part of the study was reported for Days 92 to 182.
Data presented is based on the Safety Analysis Population which differs from the Intent to Treat Population (ITT) presented in the Baseline Characteristics and Outcomes sections. Refer to SAP. All participants in the Open-label Extsion portion of the study received LYT-100 (total N = 107) and are grouped for safety presentation. One death in the Placebo Group occurred during the Double-blind part of the study, but no formal mortality analysis was performed.
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Additional Information
Head of Program Strategy and Clinical Operations
PureTech Health
Phone: 6177211988
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place