| Group | Value | 95% CI |
|---|---|---|
| Firsocostat 5 mg | 70.6 | |
| Firsocostat 20 mg | 71.4 | |
| Placebo | 61.5 |
Last reviewed · How we verify
NCT02856555
Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis
Phase 2 trial testing Firsocostat in Nonalcoholic Steatohepatitis (NASH) in 127 participants. Completed in 18 July 2017.
18 July 2017
Quick facts
| Lead sponsor | Gilead Sciences |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 127 |
| Start date | 8 August 2016 |
| Primary completion | 18 July 2017 |
| Estimated completion | 18 July 2017 |
| Sites | 36 locations across United States |
Drugs / interventions tested
- Firsocostat — full drug profile →
- Placebo
Conditions studied
- Nonalcoholic Steatohepatitis (NASH) — all drugs for Nonalcoholic Steatohepatitis (NASH) →
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.
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.
Serious adverse events (6 terms)
| Reaction | System | Firsocostat 5 mg | Firsocostat 20 mg | Placebo |
|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Diverticulitis | Infections and infestations | — | — | — |
| Sepsis | Infections and infestations | — | — | — |
| Hepatic encephalopathy | Nervous system disorders | — | — | — |
| Transient ischaemic attack | Nervous system disorders | — | — | — |
Other adverse events (16 terms — click to expand)
| Reaction | System | Firsocostat 5 mg | Firsocostat 20 mg | Placebo |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Influenza | Infections and infestations | — | — | — |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Sinusitis | Infections and infestations | — | — | — |
| Viral upper respiratory tract infection | Infections and infestations | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Chest discomfort | General disorders | — | — | — |
| Dyspnoea | Respiratory, 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):
-
Current and future pharmacological therapies for NAFLD/NASH.
Sumida Y, Yoneda M. · · 2018 · cited 487× · PMID 29247356 · DOI 10.1007/s00535-017-1415-1 -
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 -
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 -
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 -
Lipogenesis inhibitors: therapeutic opportunities and challenges.
Batchuluun B, Pinkosky SL, Steinberg GR. · · 2022 · cited 260× · PMID 35031766 · DOI 10.1038/s41573-021-00367-2 -
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 -
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 -
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:
- PubMed search for NCT02856555
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Firsocostat
Trials testing the same drug.
- NCT03987074 — Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepat · Phase 2 · completed
- NCT02891408 — Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function · Phase 1 · completed
Other recruiting trials for Nonalcoholic Steatohepatitis (NASH)
Currently open trials in the same condition.
- NCT06216041 — To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects · Phase 1 · recruiting
- NCT05842512 — Study of ADI-PEG 20 Versus Placebo in Subjects With NASH · Phase 2 · recruiting
- NCT05692492 — A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NAS · Phase 2 · active not recruiting
- NCT03572465 — Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis · recruiting
Other Gilead Sciences trials
Trials by the same sponsor.
- NCT07115368 — Study of GS-1219 in Participants With HIV-1 · Phase 1 · terminated
- NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated
- NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain · completed
- NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated · Phase 2, PHASE3 · terminated
- NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02856555 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
- Last refreshed: 24 July 2020
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