Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH) (NCT NCT03987074)
NCT ID: NCT03987074
Last Updated: 2021-07-15
Results Overview
Treatment-emergent adverse events (TEAEs) were defined as, any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. Participants were assessed for AEs according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
109 participants
Primary outcome timeframe
First dose date up to Week 24 plus 30 days
Results posted on
2021-07-15
Participant Flow
Participants were enrolled at study sites in United States. The first participant was screened on 29 July 2019. The last study visit occurred on 13 July 2020.
209 participants were screened. 109 participants were enrolled. 1 participant was enrolled but was not randomized and was not included in the analysis.
Participant milestones
| Measure |
Semaglutide
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks.
|
Semaglutide + Firsocostat 20 mg
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Cilofexor 30 mg
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Cilofexor 100 mg
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
22
|
22
|
21
|
|
Overall Study
COMPLETED
|
18
|
20
|
21
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
1
|
4
|
2
|
Reasons for withdrawal
| Measure |
Semaglutide
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks.
|
Semaglutide + Firsocostat 20 mg
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Cilofexor 30 mg
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Cilofexor 100 mg
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrew Consent
|
1
|
1
|
0
|
2
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Investigator's Discretion
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)
Baseline characteristics by cohort
| Measure |
Semaglutide
n=21 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks.
|
Semaglutide + Firsocostat 20 mg
n=22 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Cilofexor 30 mg
n=22 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Cilofexor 100 mg
n=22 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
n=21 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 10.4 • n=99 Participants
|
52 years
STANDARD_DEVIATION 12.6 • n=107 Participants
|
51 years
STANDARD_DEVIATION 10.9 • n=206 Participants
|
54 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
53 years
STANDARD_DEVIATION 11.4 • n=31 Participants
|
53 years
STANDARD_DEVIATION 11.1 • n=30 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
74 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
34 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
92 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
65 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
43 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: First dose date up to Week 24 plus 30 daysPopulation: The Safety Analysis Set included participants who received at least 1 dose of study drug.
Treatment-emergent adverse events (TEAEs) were defined as, any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. Participants were assessed for AEs according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Outcome measures
| Measure |
Semaglutide
n=21 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks.
|
Semaglutide + Firsocostat 20 mg
n=22 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Cilofexor 30 mg
n=22 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Cilofexor 100 mg
n=22 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
n=21 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
|
81.0 percentage of participants
|
86.4 percentage of participants
|
81.8 percentage of participants
|
72.7 percentage of participants
|
90.5 percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to 24 weeks plus 30 daysPopulation: Participants in the Safety Analysis Set were analyzed.
Treatment-emergent laboratory abnormalities, defined as values that increase at least one toxicity grade from baseline at any time post-baseline up to and including the date of last dose of study drug plus 30 days, were summarized by treatment group. Graded laboratory abnormalities were defined using the grading scheme in the CTCAE 5.0.
Outcome measures
| Measure |
Semaglutide
n=21 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks.
|
Semaglutide + Firsocostat 20 mg
n=22 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Cilofexor 30 mg
n=22 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Cilofexor 100 mg
n=22 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
n=21 Participants
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 1
|
61.9 percentage of participants
|
63.6 percentage of participants
|
36.4 percentage of participants
|
50.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 2
|
23.8 percentage of participants
|
22.7 percentage of participants
|
31.8 percentage of participants
|
18.2 percentage of participants
|
9.5 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 3
|
0.0 percentage of participants
|
4.5 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 4
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
9.1 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Semaglutide
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Semaglutide + Firsocostat 20 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Semaglutide + Cilofexor 30 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Semaglutide + Cilofexor 100 mg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Semaglutide
n=21 participants at risk
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks.
|
Semaglutide + Firsocostat 20 mg
n=22 participants at risk
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Cilofexor 30 mg
n=22 participants at risk
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Cilofexor 100 mg
n=22 participants at risk
Semaglutide + Cilofexor 100 mg Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
n=21 participants at risk
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
Other adverse events
| Measure |
Semaglutide
n=21 participants at risk
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks.
|
Semaglutide + Firsocostat 20 mg
n=22 participants at risk
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Cilofexor 30 mg
n=22 participants at risk
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Cilofexor 100 mg
n=22 participants at risk
Semaglutide + Cilofexor 100 mg Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks.
|
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
n=21 participants at risk
Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
|
|---|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Eye disorders
Visual impairment
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
13.6%
3/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
18.2%
4/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.5%
2/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
3/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.5%
2/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
22.7%
5/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
13.6%
3/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
23.8%
5/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
23.8%
5/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
18.2%
4/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
22.7%
5/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
14.3%
3/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
9.5%
2/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Eructation
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.5%
2/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
18.2%
4/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
42.9%
9/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
13.6%
3/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
36.4%
8/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
27.3%
6/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
66.7%
14/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
28.6%
6/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
General disorders
Early satiety
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
13.6%
3/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
General disorders
Fatigue
|
9.5%
2/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
13.6%
3/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.5%
2/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
General disorders
Pyrexia
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.5%
2/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
13.6%
3/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.5%
2/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Investigations
Weight decreased
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.0%
4/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
18.2%
4/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
27.3%
6/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
14.3%
3/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
18.2%
4/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.8%
5/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
13.6%
3/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
13.6%
3/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Renal and urinary disorders
Dysuria
|
4.8%
1/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.5%
2/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.5%
2/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
0.00%
0/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
4.5%
1/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.1%
2/22 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
9.5%
2/21 • First dose date up to 24 weeks plus 30 days
The Safety Analysis Set included participants who received at least 1 dose of study drug
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER