Trial · NCT02466516

Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3

NCT02466516, Phase 2, Completed, Gilead Sciences; results first posted 2019-06-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3. Trials, record NCT02466516. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02466516

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
NCT number: NCT02466516
Status: Completed
Phases: Phase 2
Enrollment: 72 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Non-Alcoholic Steatohepatitis (NASH)
Interventions: SEL, SIM
First posted: 2015-06-09
Last updated: 2019-06-26
Results first posted: 2019-06-26

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality	Baseline up to last dose plus 30 days (up to Week 28)	Treatment-emergent events began on or after the first dosing date up to 30 days after the last dosing date or led to premature discontinuation of study drug. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Primary	Number of Participants Who Prematurely Discontinued Study Drug or Study Due to Adverse Events	Baseline up to follow up visit (Week 28)

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality	Baseline up to last dose plus 30 days (up to Week 28)	Safety Analysis Set included all participants who received at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Who Prematurely Discontinued Study Drug or Study Due to Adverse Events	Baseline up to follow up visit (Week 28)	Participants in the Safety Analysis Set were analyzed.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group25

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality	SEL 6 mg	TEAEs	17	Participants
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality	SEL 18 mg	TEAEs	15	Participants
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality	SEL 6 mg+SIM 125 mg	TEAEs	9	Participants
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality	SEL 18 mg+SIM 125 mg	TEAEs	9	Participants
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality	SIM 125 mg	TEAEs	7	Participants
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality	SEL 6 mg	SAEs	2	Participants
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality	SEL 18 mg	SAEs	2	Participants
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality	SEL 6 mg+SIM 125 mg	SAEs	0	Participants
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality	SEL 18 mg+SIM 125 mg	SAEs	1	Participants
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality	SIM 125 mg	SAEs	0	Participants

1 to 10 of 25Source ClinicalTrials.gov

See all 25 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SEL 6 mg	20
Overall Study	STARTED	SEL 18 mg	22
Overall Study	STARTED	SEL 6 mg+SIM 125 mg	10
Overall Study	STARTED	SEL 18 mg+SIM 125 mg	10
Overall Study	STARTED	SIM 125 mg	10
Overall Study	COMPLETED	SEL 6 mg	16
Overall Study	COMPLETED	SEL 18 mg	21
Overall Study	COMPLETED	SEL 6 mg+SIM 125 mg	9
Overall Study	COMPLETED	SEL 18 mg+SIM 125 mg	10
Overall Study	COMPLETED	SIM 125 mg	10

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events550

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Iron deficiency anaemia	Blood and lymphatic system disorders	SEL 6 mg	1	20
other	Iron deficiency anaemia	Blood and lymphatic system disorders	SEL 18 mg	0	22
other	Iron deficiency anaemia	Blood and lymphatic system disorders	SEL 6 mg+SIM 125 mg	0	10
other	Iron deficiency anaemia	Blood and lymphatic system disorders	SEL 18 mg+SIM 125 mg	0	10
other	Iron deficiency anaemia	Blood and lymphatic system disorders	SIM 125 mg	0	10
other	Abdominal distension	Gastrointestinal disorders	SEL 6 mg	1	20
other	Abdominal distension	Gastrointestinal disorders	SEL 18 mg	1	22
other	Abdominal distension	Gastrointestinal disorders	SEL 6 mg+SIM 125 mg	0	10
other	Abdominal distension	Gastrointestinal disorders	SEL 18 mg+SIM 125 mg	1	10
other	Abdominal distension	Gastrointestinal disorders	SIM 125 mg	0	10

1 to 10 of 550Source ClinicalTrials.gov

See all 550 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SEL 6 mg	0	20
Total, all-cause mortality	SEL 18 mg	0	22
Total, all-cause mortality	SEL 6 mg+SIM 125 mg	0	10
Total, all-cause mortality	SEL 18 mg+SIM 125 mg	0	10
Total, all-cause mortality	SIM 125 mg	0	10
Total, other adverse events	SEL 6 mg	17	20
Total, other adverse events	SEL 18 mg	14	22
Total, other adverse events	SEL 6 mg+SIM 125 mg	9	10
Total, other adverse events	SEL 18 mg+SIM 125 mg	9	10
Total, other adverse events	SIM 125 mg	7	10

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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