Trial Outcomes & Findings for LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH) (NCT NCT04328077)
NCT ID: NCT04328077
Last Updated: 2022-08-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
16 weeks
Results posted on
2022-08-09
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo Comparator: Placebo: Orally administered
|
TERN-101 5mg
Experimental: TERN-101 dose level 1: Orally administered
|
TERN-101 10mg
Experimental: TERN-101 dose level 2: Orally administered
|
TERN-101 15mg
Experimental: TERN-101 dose level 3: Orally administered
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
26
|
24
|
|
Overall Study
COMPLETED
|
26
|
23
|
25
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo Comparator: Placebo: Orally administered
|
TERN-101 5mg
Experimental: TERN-101 dose level 1: Orally administered
|
TERN-101 10mg
Experimental: TERN-101 dose level 2: Orally administered
|
TERN-101 15mg
Experimental: TERN-101 dose level 3: Orally administered
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
3
|
Baseline Characteristics
LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Baseline characteristics by cohort
| Measure |
Placebo
n=26 Participants
Placebo Comparator: Placebo: Orally administered
|
TERN-101 5mg
n=25 Participants
Experimental: TERN-101 dose level 1: Orally administered
|
TERN-101 10mg
n=26 Participants
Experimental: TERN-101 dose level 2: Orally administered
|
TERN-101 15mg
n=23 Participants
Experimental: TERN-101 dose level 3: Orally administered
|
Total
n=100 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
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 11.00 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 12.32 • n=7 Participants
|
52.5 years
STANDARD_DEVIATION 13.64 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 9.49 • n=4 Participants
|
50.6 years
STANDARD_DEVIATION 11.71 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
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
|
|
Race/Ethnicity, Customized
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
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
ALT
|
55.51 U/L
STANDARD_DEVIATION 23.639 • n=5 Participants
|
56.25 U/L
STANDARD_DEVIATION 16.266 • n=7 Participants
|
60.84 U/L
STANDARD_DEVIATION 29.075 • n=5 Participants
|
55.79 U/L
STANDARD_DEVIATION 26.447 • n=4 Participants
|
57.15 U/L
STANDARD_DEVIATION 24.064 • n=21 Participants
|
|
Diabetes Mellitus Status
Absent
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Diabetes Mellitus Status
Present
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Safety Population: All patients who received at least 1 dose of study drug
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo Comparator: Placebo: Orally administered
|
TERN-101 5 mg
n=25 Participants
Experimental: TERN-101 dose level 1: Orally administered
|
TERN-101 10 mg
n=26 Participants
Experimental: TERN-101 dose level 2: Orally administered
|
TERN-101 15 mg
n=23 Participants
Experimental: TERN-101 dose level 3: Orally administered
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events for TERN-101 Versus Placebo
|
10 Participants
|
13 Participants
|
14 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Population: All randomized patients who received at least 1 dose of study drug
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo Comparator: Placebo: Orally administered
|
TERN-101 5 mg
n=24 Participants
Experimental: TERN-101 dose level 1: Orally administered
|
TERN-101 10 mg
n=25 Participants
Experimental: TERN-101 dose level 2: Orally administered
|
TERN-101 15 mg
n=21 Participants
Experimental: TERN-101 dose level 3: Orally administered
|
|---|---|---|---|---|
|
Percent Change From Baseline in ALT Outcome Measure
|
-5.33 percentage of change from baseline
Standard Error 6.606
|
-2.63 percentage of change from baseline
Standard Error 6.743
|
-17.99 percentage of change from baseline
Standard Error 6.646
|
-13.22 percentage of change from baseline
Standard Error 7.246
|
SECONDARY outcome
Timeframe: 12 weeks (0-24 hours post dose)Population: All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101. The minimum requirement for the calculation of AUC required: A minimum of 3 measurable concentration-time-points during the log-linear portion of the terminal elimination phase (after tmax), excluding Cmax; r²adj ≥ 0.80 for the regression of the log-concentration time data during the terminal elimination phase; Negative slope for log regression fit.
Area under the curve
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo Comparator: Placebo: Orally administered
|
TERN-101 5 mg
n=4 Participants
Experimental: TERN-101 dose level 1: Orally administered
|
TERN-101 10 mg
n=5 Participants
Experimental: TERN-101 dose level 2: Orally administered
|
TERN-101 15 mg
Experimental: TERN-101 dose level 3: Orally administered
|
|---|---|---|---|---|
|
Plasma Concentration of TERN-101 - AUC 0-24
|
1380 h*ng/mL
Geometric Coefficient of Variation 96.7
|
1470 h*ng/mL
Geometric Coefficient of Variation 29.7
|
2510 h*ng/mL
Geometric Coefficient of Variation 13.3
|
—
|
SECONDARY outcome
Timeframe: 12 Weeks (0-72 hours post dose)Population: All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101.
Maximum observed concentration
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo Comparator: Placebo: Orally administered
|
TERN-101 5 mg
n=6 Participants
Experimental: TERN-101 dose level 1: Orally administered
|
TERN-101 10 mg
n=6 Participants
Experimental: TERN-101 dose level 2: Orally administered
|
TERN-101 15 mg
Experimental: TERN-101 dose level 3: Orally administered
|
|---|---|---|---|---|
|
Plasma Concentration of TERN-101 - Cmax
|
116 ng/mL
Geometric Coefficient of Variation 45.0
|
155 ng/mL
Geometric Coefficient of Variation 158.8
|
389 ng/mL
Geometric Coefficient of Variation 19.0
|
—
|
SECONDARY outcome
Timeframe: 12 Weeks (0-72 hours post dose)Population: All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101.
Time to reach maximum measured plasma concentration
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo Comparator: Placebo: Orally administered
|
TERN-101 5 mg
n=6 Participants
Experimental: TERN-101 dose level 1: Orally administered
|
TERN-101 10 mg
n=6 Participants
Experimental: TERN-101 dose level 2: Orally administered
|
TERN-101 15 mg
Experimental: TERN-101 dose level 3: Orally administered
|
|---|---|---|---|---|
|
Plasma Concentration of TERN-101 - Tmax
|
1 hour
Interval 0.0 to 6.0
|
1 hour
Interval 0.0 to 3.0
|
0.5 hour
Interval 0.5 to 1.0
|
—
|
SECONDARY outcome
Timeframe: 12 Weeks (0-72 hours post dose)Population: All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101. The minimum requirement for the calculation of t1/2 required: A minimum of 3 measurable concentration-time-points during the log-linear portion of the terminal elimination phase (after Tmax), excluding Cmax; r²adj ≥ 0.80 for the regression of the log-concentration time data during the terminal elimination phase; and negative slope for log regression fit.
Determination of half-life
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo Comparator: Placebo: Orally administered
|
TERN-101 5 mg
n=4 Participants
Experimental: TERN-101 dose level 1: Orally administered
|
TERN-101 10 mg
n=5 Participants
Experimental: TERN-101 dose level 2: Orally administered
|
TERN-101 15 mg
Experimental: TERN-101 dose level 3: Orally administered
|
|---|---|---|---|---|
|
Plasma Concentration of TERN-101 - t1/2
|
14.6 hour
Interval 8.7 to 67.8
|
6.75 hour
Interval 4.0 to 7.9
|
6 hour
Interval 5.8 to 11.3
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
TERN-101 5mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
TERN-101 10mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
TERN-101 15mg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=26 participants at risk
Placebo Comparator: Placebo: Orally administered
|
TERN-101 5mg
n=25 participants at risk
Experimental: TERN-101 dose level 1: Orally administered
|
TERN-101 10mg
n=26 participants at risk
Experimental: TERN-101 dose level 2: Orally administered
|
TERN-101 15mg
n=23 participants at risk
Experimental: TERN-101 dose level 3: Orally administered
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
Other adverse events
| Measure |
Placebo
n=26 participants at risk
Placebo Comparator: Placebo: Orally administered
|
TERN-101 5mg
n=25 participants at risk
Experimental: TERN-101 dose level 1: Orally administered
|
TERN-101 10mg
n=26 participants at risk
Experimental: TERN-101 dose level 2: Orally administered
|
TERN-101 15mg
n=23 participants at risk
Experimental: TERN-101 dose level 3: Orally administered
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/26 • 16 Weeks
|
12.0%
3/25 • Number of events 3 • 16 Weeks
|
11.5%
3/26 • Number of events 3 • 16 Weeks
|
17.4%
4/23 • Number of events 4 • 16 Weeks
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • Number of events 2 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
11.5%
3/26 • Number of events 3 • 16 Weeks
|
8.7%
2/23 • Number of events 2 • 16 Weeks
|
|
Gastrointestinal disorders
Constipation
|
7.7%
2/26 • Number of events 2 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
7.7%
2/26 • Number of events 2 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
2/26 • Number of events 2 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
8.7%
2/23 • Number of events 2 • 16 Weeks
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
7.7%
2/26 • Number of events 2 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/26 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Psychiatric disorders
Anxiety
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/26 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
General disorders
Fatigue
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/26 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/26 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
General disorders
Asthenia
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
Investigations
Blood glucose increased
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
Infections and infestations
Conjunctivitis
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
General disorders
Early satiety
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
General disorders
Faecaloma
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
General disorders
Flatulence
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/26 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/26 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Investigations
Hepatic enzyme increased
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Vascular disorders
Hypertension
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Infections and infestations
Influenza
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
General disorders
Influenza like illness
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
General disorders
Injection site pain
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Investigations
Magnetic resonance imaging abnormal
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/26 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/26 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/26 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
4.3%
1/23 • Number of events 1 • 16 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/26 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Infections and infestations
Soft tissue infection
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/26 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/26 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/26 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Eye disorders
Vision blurred
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • 16 Weeks
|
4.0%
1/25 • Number of events 1 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
|
Investigations
Weight increased
|
3.8%
1/26 • Number of events 1 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/23 • 16 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place