Trial Outcomes & Findings for Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis (NCT NCT02856555)

NCT ID: NCT02856555

Last Updated: 2020-07-24

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

127 participants

Primary outcome timeframe

First Dose date up to last dose (Week 12) plus 30 days

Results posted on

2020-07-24

Participant Flow

Participants were enrolled at study sites in United States. The first participant was screened on 08 August 2016. The last study visit occurred on 18 July 2017.

433 participants were screened.

Participant milestones

Participant milestones
Measure	Firsocostat 5 mg Participants received firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.	Firsocostat 20 mg Participants received firsocostat 2 x 10 mg + 2 x placebo matched to firsocostat 5 mg capsules orally once daily for 12 weeks.	Placebo Participants received 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.
Overall Study STARTED	51	50	26
Overall Study COMPLETED	46	46	26
Overall Study NOT COMPLETED	5	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Firsocostat 5 mg Participants received firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.	Firsocostat 20 mg Participants received firsocostat 2 x 10 mg + 2 x placebo matched to firsocostat 5 mg capsules orally once daily for 12 weeks.
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	1	3
Overall Study Withdrawal by Subject	3	0
Overall Study Randomized but Never Treated	0	1

Baseline Characteristics

Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Firsocostat 5 mg n=51 Participants Participants received firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.	Firsocostat 20 mg n=49 Participants Participants received firsocostat 2 x 10 mg + 2 x placebo matched to firsocostat 5 mg capsules orally once daily for 12 weeks.	Placebo n=26 Participants Participants received 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.	Total n=126 Participants Total of all reporting groups
Age, Continuous	53 years STANDARD_DEVIATION 11.6 • n=5 Participants	54 years STANDARD_DEVIATION 12.2 • n=7 Participants	56 years STANDARD_DEVIATION 9.6 • n=5 Participants	54 years STANDARD_DEVIATION 11.5 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	33 Participants n=7 Participants	19 Participants n=5 Participants	82 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	16 Participants n=7 Participants	7 Participants n=5 Participants	44 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	23 Participants n=7 Participants	8 Participants n=5 Participants	47 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants	26 Participants n=7 Participants	18 Participants n=5 Participants	79 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 · American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	5 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	42 Participants n=5 Participants	44 Participants n=7 Participants	23 Participants n=5 Participants	109 Participants n=4 Participants
Race/Ethnicity, Customized Race · Others	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: First Dose date up to last dose (Week 12) plus 30 days

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

Outcome measures

Outcome measures
Measure	Firsocostat 5 mg n=51 Participants Participants received firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.	Firsocostat 20 mg n=49 Participants Participants received firsocostat 2 x 10 mg + 2 x placebo matched to firsocostat 5 mg capsules orally once daily for 12 weeks.	Placebo n=26 Participants Participants received 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events	70.6 percentage of participants	71.4 percentage of participants	61.5 percentage of participants

Adverse Events

Firsocostat 5 mg

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Firsocostat 20 mg

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Firsocostat 5 mg n=51 participants at risk Participants received firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.	Firsocostat 20 mg n=49 participants at risk Participants received firsocostat 2 x 10 mg + 2 x placebo matched to firsocostat 5 mg capsules orally once daily for 12 weeks.	Placebo n=26 participants at risk Participants received 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.
Gastrointestinal disorders Abdominal pain	0.00% 0/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.0% 1/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Pyrexia	2.0% 1/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Diverticulitis	2.0% 1/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Sepsis	0.00% 0/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.0% 1/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Hepatic encephalopathy	0.00% 0/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.0% 1/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Transient ischaemic attack	0.00% 0/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.0% 1/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received 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	Firsocostat 5 mg n=51 participants at risk Participants received firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.	Firsocostat 20 mg n=49 participants at risk Participants received firsocostat 2 x 10 mg + 2 x placebo matched to firsocostat 5 mg capsules orally once daily for 12 weeks.	Placebo n=26 participants at risk Participants received 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg capsules orally once daily for 12 weeks.
Gastrointestinal disorders Nausea	7.8% 4/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	14.3% 7/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	7.7% 2/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	9.8% 5/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	12.2% 6/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	3.9% 2/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	10.2% 5/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.8% 1/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	3.9% 2/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	8.2% 4/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.8% 1/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	2.0% 1/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	10.2% 5/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	3.9% 2/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	7.7% 2/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Fatigue	3.9% 2/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	8.2% 4/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	11.5% 3/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Chest discomfort	0.00% 0/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	7.7% 2/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Sinusitis	3.9% 2/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	6.1% 3/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	11.5% 3/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Influenza	0.00% 0/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	10.2% 5/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.8% 1/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Viral upper respiratory tract infection	5.9% 3/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.0% 1/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	9.8% 5/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.0% 1/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Headache	9.8% 5/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	8.2% 4/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.8% 1/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Psychiatric disorders Anxiety	5.9% 3/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	3.8% 1/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 3/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	2.0% 1/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 1/51 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/49 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.	7.7% 2/26 • First Dose date up to last dose (Week 12) plus 30 days The Safety Analysis Set included participants who received at least 1 dose of study drug.