Trial Outcomes & Findings for AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NCT NCT04897594)
NCT ID: NCT04897594
Last Updated: 2024-06-07
Results Overview
Number of patients experiencing at least 1 TEAE (Safety Analysis Set). TEAE = Treatment-emergent adverse event. Please see additional details in Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Day 1 through Week 16
Results posted on
2024-06-07
Participant Flow
Participant milestones
| Measure |
Placebo
Patients who orally administered the Placebo
|
TERN-201 10mg
Patients who orally administered 10mg of TERN-201
|
TERN-201 20mg
Patients who orally administered 20mg of TERN-201
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
20
|
15
|
|
Overall Study
COMPLETED
|
16
|
19
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Patients who orally administered the Placebo
|
TERN-201 10mg
Patients who orally administered 10mg of TERN-201
|
TERN-201 20mg
Patients who orally administered 20mg of TERN-201
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
Baseline Characteristics
AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=17 Participants
Patients who orally administered the Placebo
|
TERN-201 10mg
n=20 Participants
Patients who orally administered 10mg of TERN-201
|
TERN-201 20mg
n=15 Participants
Patients who orally administered 20mg of TERN-201
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
49 years
n=7 Participants
|
48 years
n=5 Participants
|
50.5 years
n=4 Participants
|
|
Age, Customized
< 65 years
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Age, Customized
>= 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 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
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Week 16Population: Safety Analysis Set consists of all patients who received at least 1 dose of study drug.
Number of patients experiencing at least 1 TEAE (Safety Analysis Set). TEAE = Treatment-emergent adverse event. Please see additional details in Adverse Events section.
Outcome measures
| Measure |
Placebo
n=17 Participants
Patients who orally administered the Placebo
|
TERN-201 10mg
n=20 Participants
Patients who orally administered 10mg of TERN-201
|
TERN-201 20mg
n=15 Participants
Patients who orally administered 20mg of TERN-201
|
|---|---|---|---|
|
Patient Incidence of Adverse Events for TERN-201 Versus Placebo
|
9 Participants
|
11 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Week 16Population: Safety Analysis Set consists of all patients who received at least 1 dose of study drug.
Number of patients with any worsening of ≥ 2 NCI CTCAE Grades in each laboratory assessment category. CTCAE = Common Terminology Criteria for Adverse Events; NCI = National Cancer Institute; laboratory abnormalities were classified according to NCI CTCAE, version 5, Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-Threatening
Outcome measures
| Measure |
Placebo
n=17 Participants
Patients who orally administered the Placebo
|
TERN-201 10mg
n=20 Participants
Patients who orally administered 10mg of TERN-201
|
TERN-201 20mg
n=15 Participants
Patients who orally administered 20mg of TERN-201
|
|---|---|---|---|
|
Treatment-Emergent Laboratory Abnormalities
Serum Chemistry
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Treatment-Emergent Laboratory Abnormalities
Fasting Lipids
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-Emergent Laboratory Abnormalities
Hematology
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
TERN-201 10mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
TERN-201 20mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=17 participants at risk
Patients who orally administered the Placebo
|
TERN-201 10mg
n=20 participants at risk
Patients who orally administered 10mg of TERN-201
|
TERN-201 20mg
n=15 participants at risk
Patients who orally administered 20mg of TERN-201
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Day 1 through Week 16
|
5.0%
1/20 • Day 1 through Week 16
|
6.7%
1/15 • Day 1 through Week 16
|
|
Gastrointestinal disorders
Nausea
|
11.8%
2/17 • Day 1 through Week 16
|
10.0%
2/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Day 1 through Week 16
|
5.0%
1/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/17 • Day 1 through Week 16
|
5.0%
1/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/17 • Day 1 through Week 16
|
5.0%
1/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
1/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Gastrointestinal disorders
Toothache
|
5.9%
1/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Infections and infestations
COVID-19
|
0.00%
0/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
6.7%
1/15 • Day 1 through Week 16
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/17 • Day 1 through Week 16
|
5.0%
1/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Infections and infestations
Sinusitis
|
0.00%
0/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
6.7%
1/15 • Day 1 through Week 16
|
|
Infections and infestations
Tooth infection
|
0.00%
0/17 • Day 1 through Week 16
|
5.0%
1/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • Day 1 through Week 16
|
5.0%
1/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Infections and infestations
Urinary tract infection
|
11.8%
2/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
6.7%
1/15 • Day 1 through Week 16
|
|
Infections and infestations
Helicobacter infection
|
5.9%
1/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Infections and infestations
Influenza
|
5.9%
1/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Infections and infestations
Tooth abscess
|
5.9%
1/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
6.7%
1/15 • Day 1 through Week 16
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/17 • Day 1 through Week 16
|
5.0%
1/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
6.7%
1/15 • Day 1 through Week 16
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
6.7%
1/15 • Day 1 through Week 16
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • Day 1 through Week 16
|
5.0%
1/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Nervous system disorders
Migraine
|
5.9%
1/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Nervous system disorders
Paraesthesia
|
5.9%
1/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
6.7%
1/15 • Day 1 through Week 16
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/17 • Day 1 through Week 16
|
5.0%
1/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.9%
1/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/17 • Day 1 through Week 16
|
5.0%
1/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
6.7%
1/15 • Day 1 through Week 16
|
|
Injury, poisoning and procedural complications
Thermal burn
|
5.9%
1/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/17 • Day 1 through Week 16
|
5.0%
1/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
General disorders
Fatigue
|
11.8%
2/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Metabolism and nutrition disorders
Increased appetite
|
11.8%
2/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.9%
1/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
5.9%
1/17 • Day 1 through Week 16
|
0.00%
0/20 • Day 1 through Week 16
|
0.00%
0/15 • Day 1 through Week 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place