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NCT02856555

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

Completed Phase 2 Results posted Last updated 24 July 2020
What this trial tests

Phase 2 trial testing Firsocostat in Nonalcoholic Steatohepatitis (NASH) in 127 participants. Completed in 18 July 2017.

Timeline
8 August 2016
Primary endpoint
18 July 2017
18 July 2017

Quick facts

Lead sponsorGilead Sciences
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingdouble
Primary purposetreatment
Enrollment127
Start date8 August 2016
Primary completion18 July 2017
Estimated completion18 July 2017
Sites36 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Gilead Sciences — full company profile →

Who can join

Adults 18 to 75, any sex, with Nonalcoholic Steatohepatitis (NASH). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Experiencing Treatment-Emergent Adverse Events Primary · First Dose date up to last dose (Week 12) plus 30 days
GroupValue95% CI
Firsocostat 5 mg70.6
Firsocostat 20 mg71.4
Placebo61.5

Adverse events — posted to ClinicalTrials.gov

Time frame: First Dose date up to last dose (Week 12) plus 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Firsocostat 5 mg
Serious: 2/51 (4%)
Deaths: 0/51
Firsocostat 20 mg
Serious: 2/49 (4%)
Deaths: 0/49
Placebo
Serious: 0/26 (0%)
Deaths: 0/26

Serious adverse events (6 terms)

ReactionSystemFirsocostat 5 mgFirsocostat 20 mgPlacebo
Abdominal painGastrointestinal disorders
PyrexiaGeneral disorders
DiverticulitisInfections and infestations
SepsisInfections and infestations
Hepatic encephalopathyNervous system disorders
Transient ischaemic attackNervous system disorders
Other adverse events (16 terms — click to expand)

ReactionSystemFirsocostat 5 mgFirsocostat 20 mgPlacebo
NauseaGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
Abdominal painGastrointestinal disorders
VomitingGastrointestinal disorders
InfluenzaInfections and infestations
HypertriglyceridaemiaMetabolism and nutrition disorders
HeadacheNervous system disorders
Abdominal pain upperGastrointestinal disorders
FatigueGeneral disorders
SinusitisInfections and infestations
Viral upper respiratory tract infectionInfections and infestations
AnxietyPsychiatric disorders
CoughRespiratory, thoracic and mediastinal disorders
ConstipationGastrointestinal disorders
Chest discomfortGeneral disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Abdominal pain, Pyrexia, Diverticulitis, Sepsis, Hepatic encephalopathy, Transient ischaemic attack.

Data from ClinicalTrials.gov NCT02856555 adverse events section.

Sponsor's own description

The primary objective of this study is to evaluate the safety and tolerability of firsocostat in adults with nonalcoholic steatohepatitis (NASH).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current and future pharmacological therapies for NAFLD/NASH.
    Sumida Y, Yoneda M. · · 2018 · cited 487× · PMID 29247356 · DOI 10.1007/s00535-017-1415-1
  2. Dysregulated lipid metabolism links NAFLD to cardiovascular disease.
    Deprince A, Haas JT, Staels B. · · 2020 · cited 371× · PMID 33010471 · DOI 10.1016/j.molmet.2020.101092
  3. Lipid metabolic reprogramming in tumor microenvironment: from mechanisms to therapeutics.
    Jin HR, Wang J, Wang ZJ, Xi MJ, et al · · 2023 · cited 284× · PMID 37700339 · DOI 10.1186/s13045-023-01498-2
  4. GS-0976 Reduces Hepatic Steatosis and Fibrosis Markers in Patients With Nonalcoholic Fatty Liver Disease.
    Loomba R, Kayali Z, Noureddin M, Ruane P, et al · · 2018 · cited 265× · PMID 30059671 · DOI 10.1053/j.gastro.2018.07.027
  5. Lipogenesis inhibitors: therapeutic opportunities and challenges.
    Batchuluun B, Pinkosky SL, Steinberg GR. · · 2022 · cited 260× · PMID 35031766 · DOI 10.1038/s41573-021-00367-2
  6. Targeted therapeutics and novel signaling pathways in non-alcohol-associated fatty liver/steatohepatitis (NAFL/NASH).
    Xu X, Poulsen KL, Wu L, Liu S, et al · · 2022 · cited 235× · PMID 35963848 · DOI 10.1038/s41392-022-01119-3
  7. Current treatment paradigms and emerging therapies for NAFLD/NASH.
    Raza S, Rajak S, Upadhyay A, Tewari A, et al · · 2021 · cited 223× · PMID 33049668 · DOI 10.2741/4892
  8. TGFβ-induced metabolic reprogramming during epithelial-to-mesenchymal transition in cancer.
    Hua W, Ten Dijke P, Kostidis S, Giera M, et al · · 2020 · cited 187× · PMID 31822964 · DOI 10.1007/s00018-019-03398-6

Verify or expand the search:

Other trials of Firsocostat

Trials testing the same drug.

Other recruiting trials for Nonalcoholic Steatohepatitis (NASH)

Currently open trials in the same condition.

Other Gilead Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02856555.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing