Trial Outcomes & Findings for Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH) (NCT NCT02854605)

Last Updated: 2019-01-29

Results Overview

TEAEs were defined as 1 or both of the following: 1) Any adverse events (AE) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug, 2) Any AEs leading to premature discontinuation of study drug.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

140 participants

Primary outcome timeframe

Up to 24 weeks plus 30 days

Results posted on

2019-01-29

Participant Flow

Participants were enrolled at study sites in North America, Hong Kong, New Zealand, and Europe. The first participant was screened on 26 October 2016. The last study visit occurred on 09 January 2018.

327 participants were screened.

Participant milestones

Participant milestones
Measure	GS-9674 100 mg GS-9674 100 mg tablet once daily + placebo-to-match (PTM) GS-9674 30 mg tablet once daily for 24 weeks.	GS-9674 30 mg GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.	Placebo PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
Overall Study STARTED	56	56	28
Overall Study COMPLETED	53	49	24
Overall Study NOT COMPLETED	3	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	GS-9674 100 mg GS-9674 100 mg tablet once daily + placebo-to-match (PTM) GS-9674 30 mg tablet once daily for 24 weeks.	GS-9674 30 mg GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.	Placebo PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
Overall Study Adverse Event	1	5	2
Overall Study Lost to Follow-up	0	2	0
Overall Study Withdrew Consent	1	0	1
Overall Study Investigator's Discretion	1	0	0
Overall Study Protocol Violation	0	0	1

Baseline Characteristics

Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GS-9674 100 mg n=56 Participants GS-9674 100 mg tablet once daily + PTM GS-9674 30 mg tablet once daily for 24 weeks.	GS-9674 30 mg n=56 Participants GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.	Placebo n=28 Participants PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.	Total n=140 Participants Total of all reporting groups
Age, Continuous	55 Years STANDARD_DEVIATION 10.5 • n=5 Participants	51 Years STANDARD_DEVIATION 12.8 • n=7 Participants	50 Years STANDARD_DEVIATION 9.9 • n=5 Participants	53 Years STANDARD_DEVIATION 11.5 • n=4 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	37 Participants n=7 Participants	15 Participants n=5 Participants	87 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	19 Participants n=7 Participants	13 Participants n=5 Participants	53 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	19 Participants n=7 Participants	8 Participants n=5 Participants	44 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	37 Participants n=7 Participants	20 Participants n=5 Participants	96 Participants n=4 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
Race/Ethnicity, Customized Race, Customized · American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race, Customized · Asian	13 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	22 Participants n=4 Participants
Race/Ethnicity, Customized Race, Customized · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race, Customized · Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Race, Customized · White	42 Participants n=5 Participants	47 Participants n=7 Participants	21 Participants n=5 Participants	110 Participants n=4 Participants
Race/Ethnicity, Customized Race, Customized · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment New Zealand	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment Canada	12 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	25 Participants n=4 Participants
Region of Enrollment Hong Kong	5 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment United States	37 Participants n=5 Participants	43 Participants n=7 Participants	16 Participants n=5 Participants	96 Participants n=4 Participants
Region of Enrollment United Kingdom	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Switzerland	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks plus 30 days

Population: Safety Analysis Set included all participants who took at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	GS-9674 100 mg n=56 Participants GS-9674 100 mg tablet once daily + PTM GS-9674 30 mg tablet once daily for 24 weeks.	GS-9674 30 mg n=56 Participants GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.	Placebo n=28 Participants PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) TEAEs	89.3 Percentage of participants	76.8 Percentage of participants	67.9 Percentage of participants
Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) TEAEs leading to premature discontinuation of drug	1.8 Percentage of participants	8.9 Percentage of participants	7.1 Percentage of participants

PRIMARY outcome

Timeframe: Up to 24 weeks plus 30 days

Population: Safety Analysis Set

Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study.

Outcome measures

Outcome measures
Measure	GS-9674 100 mg n=56 Participants GS-9674 100 mg tablet once daily + PTM GS-9674 30 mg tablet once daily for 24 weeks.	GS-9674 30 mg n=56 Participants GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.	Placebo n=28 Participants PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities Any Grade ≥ 1	89.3 Percentage of participants	92.9 Percentage of participants	92.9 Percentage of participants
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities Grade 1	35.7 Percentage of participants	42.9 Percentage of participants	50.0 Percentage of participants
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities Grade 2	37.5 Percentage of participants	37.5 Percentage of participants	25.0 Percentage of participants
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities Grade 3	7.1 Percentage of participants	10.7 Percentage of participants	14.3 Percentage of participants
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities Grade 4	8.9 Percentage of participants	1.8 Percentage of participants	3.6 Percentage of participants

Adverse Events

GS-9674 100 mg

Serious events: 2 serious events

Other events: 39 other events

Deaths: 0 deaths

GS-9674 30 mg

Serious events: 2 serious events

Other events: 34 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GS-9674 100 mg n=56 participants at risk GS-9674 100 mg tablet once daily + PTM GS-9674 30 mg tablet once daily for 24 weeks.	GS-9674 30 mg n=56 participants at risk GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.	Placebo n=28 participants at risk PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
Hepatobiliary disorders Bile duct stone	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Reproductive system and breast disorders Pelvic pain	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Vascular disorders Hypertensive crisis	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	3.6% 1/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.

Other adverse events

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

Measure	GS-9674 100 mg n=56 participants at risk GS-9674 100 mg tablet once daily + PTM GS-9674 30 mg tablet once daily for 24 weeks.	GS-9674 30 mg n=56 participants at risk GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.	Placebo n=28 participants at risk PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
General disorders Fatigue	3.6% 2/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	12.5% 7/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	3.6% 1/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Infections and infestations Bronchitis	5.4% 3/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	5.4% 3/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Nervous system disorders Dizziness	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	7.1% 2/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo	5.4% 3/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Gastrointestinal disorders Abdominal distension	3.6% 2/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	5.4% 3/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	10.7% 3/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	8.9% 5/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	3.6% 2/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	5.4% 3/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	8.9% 5/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	3.6% 1/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Gastrointestinal disorders Constipation	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	5.4% 3/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	5.4% 3/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	5.4% 3/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	3.6% 1/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Gastrointestinal disorders Dry mouth	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	7.1% 2/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Gastrointestinal disorders Dyspepsia	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	7.1% 2/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Gastrointestinal disorders Gastritis	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	7.1% 2/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Gastrointestinal disorders Nausea	3.6% 2/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	7.1% 4/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	7.1% 2/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	5.4% 3/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	10.7% 3/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Infections and infestations Sinusitis	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	5.4% 3/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	10.7% 6/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	8.9% 5/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	7.1% 2/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Infections and infestations Urinary tract infection	7.1% 4/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	3.6% 1/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	7.1% 2/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	7.1% 2/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	3.6% 2/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	7.1% 4/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	10.7% 3/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	5.4% 3/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	3.6% 1/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Nervous system disorders Headache	7.1% 4/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	10.7% 6/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	14.3% 4/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Psychiatric disorders Depression	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	8.9% 5/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	23.2% 13/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	16.1% 9/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	17.9% 5/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus generalised	5.4% 3/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	5.4% 3/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.
Vascular disorders Hypertension	5.4% 3/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	1.8% 1/56 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.	0.00% 0/28 • Up to 24 weeks plus 30 days Safety Analysis Set included all participants who took at least 1 dose of study drug.