Acetyl-CoA Carboxylase Inhibitor GS-0976 for 12 Weeks Reduces Hepatic De Novo Lipogenesis and Steatosis in Patients With Nonalcoholic Steatohepatitis
Abstract
Background & aims Increased de novo lipogenesis (DNL) contributes to the pathogenesis of nonalcoholic steatohepatitis (NASH). Acetyl-CoA carboxylase catalyzes the rate-limiting step in DNL. We evaluated the safety and efficacy of GS-0976, a small molecule inhibitor of acetyl-CoA carboxylase, in patients with NASH. Methods In an open-label prospective study, patients with NASH (n = 10) received GS-0976 20 mg orally once daily for 12 weeks. NASH was diagnosed based on a proton density fat fraction estimated by magnetic resonance imaging (MRI-PDFF) ≥10% and liver stiffness by magnetic resonance elastography (MRE) ≥2.88 kPa. The contribution from hepatic DNL to plasma palmitate was measured by 14 days of heavy water labeling before and at the end of treatment. We performed the same labelling protocol in an analysis of healthy volunteers who were not given DNL (controls, n = 10). MRI-PDFF and MRE at baseline, and at weeks 4 and 12 of GS-0976 administration, were measured. We analyzed markers of liver injury and serum markers of fibrosis. Results The contribution of hepatic DNL to plasma palmitate was significantly greater in patients with NASH compared with controls (43% vs 18%) (P = .003). After 12 weeks administration of GS-0976, the median hepatic DNL was reduced 22% from baseline in patients with NASH (P = .004). Compared with baseline, reductions in MRI-PDFF at week 12 (15.7% vs 9.1% at baseline; P = .006), liver stiffness by MRE (3.4 kPa vs 3.1 kPa at baseline; P = .049), TIMP metallopeptidase inhibitor 1 (275 ng/mL vs 244 ng/mL at baseline; P = .049), and serum level of alanine aminotransferase (101 U/L vs 57 U/L at baseline; P = .23) were consistent with decreased hepatic lipid content and liver injury. At week 12, 7 patients (70%) had a ≥30% decrease in MRI-PDFF. Conclusion In an open-label study, patients with NASH given GS-0976 for 12 weeks had reduced hepatic DNL, steatosis, and markers of liver injury. ClinicalTrials.gov no: NCT02856555.
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In obesity and insulin resistance, not only influx of NEFA to liver increases considerably, but also DNL shows an up to five-fold rise.
“In obesity and insulin resistance, not only the influx of NEFA to the liver increases considerably, but also DNL shows an up to five-fold rise [220,221]”
From Obesity and MASLD: Is weight loss the (only) key to treat metabolic liver disease? (2024) · cites this paper as [221]
Cites
Neuschwander‐Tetri, B. A. (2010) · Hepatology · doi:10.1002/hep.23719 · Cited by 1,077 · see citing works
Lambert, J. E., Ramos–Roman, M. A., Browning, J. D., & Parks, E. J. (2014) · Gastroenterology · doi:10.1053/j.gastro.2013.11.049 · Cited by 1,069 · see citing works
Savage, D. B. (2006) · Journal of Clinical Investigation · doi:10.1172/jci27300 · Cited by 447 · see citing works
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The complex link between NAFLD and type 2 diabetes mellitus - mechanisms and treatments
Targher, G., Corey, K. E., Byrne, C. D., & Roden, M. (2021) · Nature Reviews Gastroenterology & Hepatology · doi:10.1038/s41575-021-00448-y · Cited by 850 · see citing works
Insulin resistance drives hepatic de novo lipogenesis in nonalcoholic fatty liver disease
Smith, G. I., Shankaran, M., Yoshino, M., Schweitzer, G. G., Chondronikola, M., Beals, J. W., Okunade, A. L., Patterson, B. W., Nyangau, E., Field, T., et al. (2020) · Journal of Clinical Investigation · doi:10.1172/jci134165 · Cited by 771 · see citing works
Self-citationTanase, D. M., Gosav, E. M., Costea, C. F., Ciocoiu, M., Lacatusu, C. M., Maranduca, M. A., Ouatu, A., & Floria, M. (2020) · Journal of Diabetes Research · doi:10.1155/2020/3920196 · Cited by 627 · see citing works
Loomba, R., Kayali, Z., Noureddin, M., Ruane, P., Lawitz, E. J., Bennett, M., Wang, L., Harting, E., Tarrant, J. M., McColgan, B. J., et al. (2018) · Gastroenterology · doi:10.1053/j.gastro.2018.07.027 · Cited by 340 · see citing works
Self-citationLoomba, R., Noureddin, M., Kowdley, K. V., Kohli, A., Sheikh, A., Neff, G., Bhandari, B. R., Gunn, N., Caldwell, S. H., Goodman, Z., et al. (2021) · Hepatology · doi:10.1002/hep.31622 · Cited by 296 · see citing works
Self-citationBoland, M. L., Laker, R. C., Mather, K., Nawrocki, A., Oldham, S., Boland, B. B., Lewis, H., Conway, J., Naylor, J., Guionaud, S., et al. (2020) · Nature Metabolism · doi:10.1038/s42255-020-0209-6 · Cited by 270 · see citing works
Bates, J., Vijayakumar, A., Ghoshal, S., Marchand, B., Yi, S., Kornyeyev, D., Zagorska, A., Hollenback, D., Walker, K., Liu, K., et al. (2020) · Journal of Hepatology · doi:10.1016/j.jhep.2020.04.037 · Cited by 230 · see citing works
Nonalcoholic fatty liver disease in adults: current concepts in etiology, outcomes, and management
Marjot, T., Moolla, A., Cobbold, J. F., Hodson, L., & Tomlinson, J. W. (2020) · Endocrine Reviews · doi:10.1210/endrev/bnz009 · Cited by 228 · see citing works
Alkhouri, N., Lawitz, E., Noureddin, M., DeFronzo, R., & Shulman, G. I. (2020) · Expert Opinion on Investigational Drugs · doi:10.1080/13543784.2020.1668374 · Cited by 162 · see citing works
Self-citationObesity and MASLD: Is weight loss the (only) key to treat metabolic liver disease?
Huttasch, M., Roden, M., & Kahl, S. (2024) · Metabolism · doi:10.1016/j.metabol.2024.155937 · Cited by 169 · see citing works
Andersson, A., Kelly, M., Imajo, K., Nakajima, A., Fallowfield, J. A., Hirschfield, G., Pavlides, M., Sanyal, A. J., Noureddin, M., Banerjee, R., et al. (2022) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2021.09.041 · Cited by 148 · see citing works
Acetyl-CoA Carboxylase Inhibition Improves Multiple Dimensions of NASH Pathogenesis in Model Systems
Ross, T. T., Crowley, C., Kelly, K. L., Rinaldi, A., Beebe, D. A., Lech, M. P., Martinez, R. V., Carvajal-Gonzalez, S., Boucher, M., Hirenallur-Shanthappa, D., et al. (2020) · Cellular and Molecular Gastroenterology and Hepatology · doi:10.1016/j.jcmgh.2020.06.001 · Cited by 94 · see citing works
Truong, X. T., & Lee, D. H. (2025) · Diabetes & Metabolism Journal · doi:10.4093/dmj.2025.0644 · Cited by 84 · see citing works
Harrison, S. A., Manghi, F. P., Smith, W. B., Alpenidze, D., Aizenberg, D., Klarenbeek, N., Chen, C.-Y., Zuckerman, E., Ravussin, E., Charatcharoenwitthaya, P., et al. (2022) · Nature Medicine · doi:10.1038/s41591-022-01861-9 · Cited by 75 · see citing works
Gut-pancreas-liver Axis as a target for treatment of NAFLD/NASH
Svegliati-Baroni, G., Patrício, B., Lioci, G., Macedo, M. P., & Gastaldelli, A. (2020) · International Journal of Molecular Sciences · doi:10.3390/ijms21165820 · Cited by 66 · see citing works
Azzu, V., Vacca, M., Kamzolas, I., Hall, Z., Leslie, J., Carobbio, S., Virtue, S., Davies, S. E., Lukasik, A., Dale, M., et al. (2021) · Molecular Metabolism · doi:10.1016/j.molmet.2021.101210 · Cited by 52 · see citing works
The interplay between nonalcoholic fatty liver disease and atherosclerotic cardiovascular disease
Finney, A. C., Das, S., Kumar, D., McKinney, M. P., Cai, B., Yurdagul, A., & Rom, O. (2023) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2023.1116861 · Cited by 40 · see citing works
Zhu, Z., Zhang, X., Pan, Q., Zhang, L., & Chai, J. (2023) · Liver Research · doi:10.1016/j.livres.2023.11.003 · Cited by 38 · see citing works
Fu, X., Fletcher, J. A., Deja, S., Inigo-Vollmer, M., Burgess, S. C., & Browning, J. D. (2023) · Journal of Clinical Investigation · doi:10.1172/jci167442 · Cited by 30 · see citing works
Weight loss in MASLD restores the balance of liver fatty acid sources
Lambert, J. E., Ramos-Roman, M. A., Valdez, M. J., Browning, J. D., Rogers, T., & Parks, E. J. (2025) · Journal of Clinical Investigation · doi:10.1172/jci174233 · Cited by 20 · see citing works
- Authors
- Lawitz, E. J., Coste, A., Poordad, F., Alkhouri, N., Loo, N., McColgan, B. J., Tarrant, J. M., Nguyen, T., Han, L., Chung, C., Ray, A. S., McHutchison, J. G., Subramanian, G. M., Myers, R. P., Middleton, M. S., Sirlin, C., Loomba, R., Nyangau, E., Fitch, M., Li, K., & Hellerstein, M.
- Affiliations
- The University of Texas at San Antonio Health Science Center (US)
- Gilead Sciences (United States) (US)
- University of California San Diego (US)
- University of California, Berkeley (US)
- Corresponding author
- Lawitz, Eric J.
- ORCID
- Venue
- Clinical Gastroenterology and Hepatology
- Publisher
- Elsevier BV
- Published
- 2018-12
- Volume
- 16
- Issue
- 12
- Pages
- 1983-1991.e3
- ISSN
- 1542-3565 (ISSN-L)
- OpenAlex
- W2799863868
- Cited by
- 217
- References
- 3
- Citations by year
- 2026: 9 · 2025: 20 · 2024: 28 · 2023: 22 · 2022: 29 · 2021: 37 · 2020: 42 · 2019: 18 · 2018: 12
- FWCI
- 21.37
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Gastroenterology and Hepatology (publishedVersion)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
- Health Sciences › Medicine › Hepatology › Liver physiology and pathology
- Keywords
- nonalcoholic steatohepatitis, acetyl-CoA carboxylase inhibitors, de novo lipogenesis, hepatic steatosis, liver fibrosis, liver stiffness, MRI-PDFF, heavy water labeling, TIMP-1, alanine aminotransferase, drug safety and efficacy
- MeSH terms
- Acetyl-CoA Carboxylase, Administration, Oral, Adolescent, Adult, Aged, Enzyme Inhibitors, Female, Humans, Liver, Magnetic Resonance Imaging, Male, Middle Aged, Oxazoles, Prospective Studies, Pyrimidines, Treatment Outcome, Lipogenesis, Elasticity Imaging Techniques, Young Adult, Isobutyrates, Non-alcoholic Fatty Liver Disease
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