Trial Outcomes & Findings for DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis (NCT NCT05415722)
NCT ID: NCT05415722
Last Updated: 2025-03-12
Results Overview
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a non-invasive imaging technique that measures fat content in tissue, particularly in the liver. Relative change from baseline is calculated for each subject as 100 x \[(Week 12 Value - Baseline Value)/Baseline Value\].
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
162 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-03-12
Participant Flow
A total of 591 patients were screened with 429 patients failing screening.
Participant milestones
| Measure |
Arm 1: TERN-501 1 mg
Orally administered.
TERN-501: Investigational drug
|
Arm 2: TERN-501 3 mg
Orally administered.
TERN-501: Investigational drug
|
Arm 3: TERN-501 6 mg
Orally administered.
TERN-501: Investigational drug
|
Arm 4: TERN-501 3 mg + TERN-101 10 mg
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 5: TERN-501 6 mg + TERN-101 10 mg
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 6:TERN-101 10 mg
Orally administered.
TERN-101: Investigational drug
|
Arm 7: Matching Placebo
Orally administered.
Placebo: Matching placebo
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
22
|
23
|
23
|
24
|
24
|
|
Overall Study
Treated
|
23
|
23
|
22
|
23
|
23
|
24
|
24
|
|
Overall Study
Discontinued Treatment
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
23
|
20
|
22
|
19
|
21
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
4
|
2
|
1
|
3
|
Reasons for withdrawal
| Measure |
Arm 1: TERN-501 1 mg
Orally administered.
TERN-501: Investigational drug
|
Arm 2: TERN-501 3 mg
Orally administered.
TERN-501: Investigational drug
|
Arm 3: TERN-501 6 mg
Orally administered.
TERN-501: Investigational drug
|
Arm 4: TERN-501 3 mg + TERN-101 10 mg
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 5: TERN-501 6 mg + TERN-101 10 mg
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 6:TERN-101 10 mg
Orally administered.
TERN-101: Investigational drug
|
Arm 7: Matching Placebo
Orally administered.
Placebo: Matching placebo
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Sponsor Discretion
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
1
|
0
|
1
|
Baseline Characteristics
DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis
Baseline characteristics by cohort
| Measure |
Arm 1: TERN-501 1 mg
n=23 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 2: TERN-501 3 mg
n=23 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 3: TERN-501 6 mg
n=22 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 4: TERN-501 3 mg + TERN-101 10 mg
n=23 Participants
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 5: TERN-501 6 mg + TERN-101 10 mg
n=23 Participants
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 6:TERN-101 10 mg
n=24 Participants
Orally administered.
TERN-101: Investigational drug
|
Arm 7: Matching Placebo
n=24 Participants
Orally administered.
Placebo: Matching placebo
|
Total
n=162 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
132 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
30 Participants
n=24 Participants
|
|
Age, Continuous
|
56.0 years
n=5 Participants
|
55.0 years
n=7 Participants
|
53.0 years
n=5 Participants
|
59.0 years
n=4 Participants
|
56.0 years
n=21 Participants
|
56.5 years
n=8 Participants
|
53.5 years
n=8 Participants
|
55.5 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
89 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
73 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
99 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
63 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
139 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other (Puerto Rican)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set: All patients who were randomized and received at least 1 dose of the study. Primary analyses were based on observed data, i.e. no imputation was performed for missing data at Week 12. Therefore, the number of patients analyzed at Week 12 may not be the same as the number of patients treated.
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a non-invasive imaging technique that measures fat content in tissue, particularly in the liver. Relative change from baseline is calculated for each subject as 100 x \[(Week 12 Value - Baseline Value)/Baseline Value\].
Outcome measures
| Measure |
Arm 1: TERN-501 1 mg
n=23 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 2: TERN-501 3 mg
n=19 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 3: TERN-501 6 mg
n=18 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 7: Matching Placebo
n=21 Participants
Orally administered.
Placebo: Matching placebo
|
Arm 5: TERN-501 6 mg + TERN-101 10 mg
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 6:TERN-101 10 mg
Orally administered.
TERN-101: Investigational drug
|
Arm 7: Matching Placebo
Orally administered.
Placebo: Matching placebo
|
|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo.
|
-15.39 Percent change from baseline
Standard Error 5.186
|
-27.48 Percent change from baseline
Standard Error 5.740
|
-44.81 Percent change from baseline
Standard Error 5.856
|
-4.01 Percent change from baseline
Standard Error 5.416
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set: All randomized patients who received at least 1 dose of study drug. Primary analyses were based on observed data, i.e. no imputation was performed for missing data at Week 12. Therefore, the number of patients analyzed at Week 12 may not be the same as the number of patients treated.
Corrected T1 (cT1) is a quantitative MRI relaxation parameter that measures liver inflammation and fibrosis. Change from baseline is calculated for each subject as (Week 12 Value - Baseline Value).
Outcome measures
| Measure |
Arm 1: TERN-501 1 mg
n=22 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 2: TERN-501 3 mg
n=19 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 3: TERN-501 6 mg
n=18 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 7: Matching Placebo
n=21 Participants
Orally administered.
Placebo: Matching placebo
|
Arm 5: TERN-501 6 mg + TERN-101 10 mg
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 6:TERN-101 10 mg
Orally administered.
TERN-101: Investigational drug
|
Arm 7: Matching Placebo
Orally administered.
Placebo: Matching placebo
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo
|
-28.2 msec
Standard Error 14.62
|
-25.6 msec
Standard Error 15.71
|
-72.0 msec
Standard Error 16.12
|
3.6 msec
Standard Error 14.92
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set: All randomized patients who received at least 1 dose of study drug. Primary analyses were based on observed data, i.e. no imputation was performed for missing data at Week 12. Therefore, the number of patients analyzed at Week 12 may not be the same as the number of patients treated.
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a non-invasive imaging technique that measures fat content in tissue, particularly in the liver. Relative change from baseline is calculated for each subject as 100 x \[(Week 12 Value - Baseline Value)/Baseline Value\].
Outcome measures
| Measure |
Arm 1: TERN-501 1 mg
n=19 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 2: TERN-501 3 mg
n=21 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 3: TERN-501 6 mg
n=21 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 7: Matching Placebo
Orally administered.
Placebo: Matching placebo
|
Arm 5: TERN-501 6 mg + TERN-101 10 mg
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 6:TERN-101 10 mg
Orally administered.
TERN-101: Investigational drug
|
Arm 7: Matching Placebo
Orally administered.
Placebo: Matching placebo
|
|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo
|
-20.75 Percent change from baseline
Standard Error 5.713
|
-47.74 Percent change from baseline
Standard Error 5.412
|
-4.01 Percent change from baseline
Standard Error 5.416
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set: All randomized patients who received at least 1 dose of study drug. Primary analyses were based on observed data, i.e. no imputation was performed for missing data at Week 12. Therefore, the number of patients analyzed at Week 12 may not be the same as the number of patients treated.
Corrected T1 (cT1) is a quantitative MRI relaxation parameter that measures liver inflammation and fibrosis. Change from baseline is calculated for each subject as (Week 12 Value - Baseline Value).
Outcome measures
| Measure |
Arm 1: TERN-501 1 mg
n=18 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 2: TERN-501 3 mg
n=21 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 3: TERN-501 6 mg
n=21 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 7: Matching Placebo
Orally administered.
Placebo: Matching placebo
|
Arm 5: TERN-501 6 mg + TERN-101 10 mg
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 6:TERN-101 10 mg
Orally administered.
TERN-101: Investigational drug
|
Arm 7: Matching Placebo
Orally administered.
Placebo: Matching placebo
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo
|
-59.0 msec
Standard Error 16.25
|
-65.5 msec
Standard Error 14.99
|
3.6 msec
Standard Error 14.92
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: All 162 patients who were randomized and received at least 1 dose of study drug were included in the Safety Analysis Set
This outcome measures the number and percentage of participants with any Treatment Emergent Adverse Event (TEAE) for All Treatment Groups (0% Threshold). TEAEs by System Organ Class and Preferred Term meeting the 5% Threshold are reported in the Other Adverse Events section.
Outcome measures
| Measure |
Arm 1: TERN-501 1 mg
n=23 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 2: TERN-501 3 mg
n=23 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 3: TERN-501 6 mg
n=22 Participants
Orally administered.
TERN-501: Investigational drug
|
Arm 7: Matching Placebo
n=23 Participants
Orally administered.
Placebo: Matching placebo
|
Arm 5: TERN-501 6 mg + TERN-101 10 mg
n=23 Participants
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 6:TERN-101 10 mg
n=24 Participants
Orally administered.
TERN-101: Investigational drug
|
Arm 7: Matching Placebo
n=24 Participants
Orally administered.
Placebo: Matching placebo
|
|---|---|---|---|---|---|---|---|
|
Number and Percentage of Participants With Any Treatment Emergent Adverse Event for All Treatment Groups (Threshold of 0%)
|
11 Participants
|
13 Participants
|
11 Participants
|
14 Participants
|
12 Participants
|
10 Participants
|
11 Participants
|
Adverse Events
Arm 1: TERN-501 1 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 2: TERN-501 3 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 3: TERN-501 6 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 4: TERN-501 3 mg + TERN-101 10 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm 5: TERN-501 6 mg + TERN-101 10 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm 6:TERN-101 10 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 7: Matching Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: TERN-501 1 mg
n=23 participants at risk
Orally administered.
TERN-501: Investigational drug
|
Arm 2: TERN-501 3 mg
n=23 participants at risk
Orally administered.
TERN-501: Investigational drug
|
Arm 3: TERN-501 6 mg
n=22 participants at risk
Orally administered.
TERN-501: Investigational drug
|
Arm 4: TERN-501 3 mg + TERN-101 10 mg
n=23 participants at risk
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 5: TERN-501 6 mg + TERN-101 10 mg
n=23 participants at risk
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 6:TERN-101 10 mg
n=24 participants at risk
Orally administered.
TERN-101: Investigational drug
|
Arm 7: Matching Placebo
n=24 participants at risk
Orally administered.
Placebo: Matching placebo
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/23 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.2%
1/24 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/23 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/22 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.2%
1/24 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
Other adverse events
| Measure |
Arm 1: TERN-501 1 mg
n=23 participants at risk
Orally administered.
TERN-501: Investigational drug
|
Arm 2: TERN-501 3 mg
n=23 participants at risk
Orally administered.
TERN-501: Investigational drug
|
Arm 3: TERN-501 6 mg
n=22 participants at risk
Orally administered.
TERN-501: Investigational drug
|
Arm 4: TERN-501 3 mg + TERN-101 10 mg
n=23 participants at risk
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 5: TERN-501 6 mg + TERN-101 10 mg
n=23 participants at risk
Orally administered.
TERN-501: Investigational drug
TERN-101: Investigational drug
|
Arm 6:TERN-101 10 mg
n=24 participants at risk
Orally administered.
TERN-101: Investigational drug
|
Arm 7: Matching Placebo
n=24 participants at risk
Orally administered.
Placebo: Matching placebo
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/23 • 16 weeks
|
8.7%
2/23 • 16 weeks
|
13.6%
3/22 • 16 weeks
|
30.4%
7/23 • 16 weeks
|
17.4%
4/23 • 16 weeks
|
4.2%
1/24 • 16 weeks
|
12.5%
3/24 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
1/23 • 16 weeks
|
21.7%
5/23 • 16 weeks
|
9.1%
2/22 • 16 weeks
|
8.7%
2/23 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.2%
1/24 • 16 weeks
|
4.2%
1/24 • 16 weeks
|
|
General disorders
Headache
|
4.3%
1/23 • 16 weeks
|
4.3%
1/23 • 16 weeks
|
4.5%
1/22 • 16 weeks
|
8.7%
2/23 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.2%
1/24 • 16 weeks
|
8.3%
2/24 • 16 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
1/23 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.5%
1/22 • 16 weeks
|
13.0%
3/23 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
8.3%
2/24 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23 • 16 weeks
|
8.7%
2/23 • 16 weeks
|
4.5%
1/22 • 16 weeks
|
4.3%
1/23 • 16 weeks
|
8.7%
2/23 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/23 • 16 weeks
|
4.3%
1/23 • 16 weeks
|
9.1%
2/22 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
0.00%
0/23 • 16 weeks
|
4.2%
1/24 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place