Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis

Background & Aims: Aldafermin, an engineered analog of fibroblast growth factor 19, inhibits bile acid synthesis and regulates metabolic homeostasis. We report results from a 24-week, phase 2 study, with serial liver biopsies, of patients with nonalcoholic steatohepatitis (NASH).Methods: We performed a double-blind study of 78 patients with NASH at 9 centers in the United States. Key inclusion criteria were biopsy-proven NASH with Nonalcoholic Fatty Liver Disease Activity Score ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content ≥8%, measured by magnetic resonance imaging-proton density fat fraction. Patients were randomly assigned (1:2) to groups given subcutaneous placebo (n = 25) or aldafermin 1 mg (n = 53) daily for 24 weeks. The primary outcome was change in absolute liver fat content from baseline at week 24. Secondary outcomes included serum markers and histologic measures of fibrosis improvement and NASH resolution.Results: At week 24, the aldafermin group had a significant reduction in absolute liver fat content (reduction of 7.7%) compared with placebo (reduction of 2.7%; difference, reduction of 5.0%; 95% confidence interval, reduction of 8.0%−1.9%; P = .002). Aldafermin produced significantly greater decreases in levels of 7α-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and neoepitope-specific N-terminal pro-peptide of type III collagen (Pro-C3) than placebo. Fibrosis improvement (≥1 stage) with no worsening of NASH was achieved in 38% of patients receiving aldafermin vs 18% of patients receiving placebo (P = .10). NASH resolution with no worsening of fibrosis was observed in 24% of patients given aldafermin vs 9% of patients given placebo (P = .20). Discontinuations due to adverse events occurred in no patients in the aldafermin group and 4% of patients in the placebo group.Conclusions: In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. ClinicalTrials.gov, Number: NCT02443116. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Harrison, Stephen A. [verfasserIn] Neff, Guy [verfasserIn] Guy, Cynthia D. [verfasserIn] Bashir, Mustafa R. [verfasserIn] Paredes, Angelo H. [verfasserIn] Frias, Juan P. [verfasserIn] Younes, Ziad [verfasserIn] Trotter, James F. [verfasserIn] Gunn, Nadege T. [verfasserIn] Moussa, Sam E. [verfasserIn] Kohli, Anita [verfasserIn] Nelson, Kristin [verfasserIn] Gottwald, Mildred [verfasserIn] Chang, William C.G. [verfasserIn] Yan, Andrew Z. [verfasserIn] DePaoli, Alex M. [verfasserIn] Ling, Lei [verfasserIn] Lieu, Hsiao D. [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2021

Schlagwörter:	Nonalcoholic Fatty Liver Disease NAFLD Metabolism Lipid

Übergeordnetes Werk:	Enthalten in: Gastroenterology - Stanford, Calif. : HighWire Press, 1965, 160
Übergeordnetes Werk:	volume:160

DOI / URN:	10.1053/j.gastro.2020.08.004

Katalog-ID:	ELV05249408X

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100	1		\|a Harrison, Stephen A. \|e verfasserin \|4 aut
245	1	0	\|a Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis
264		1	\|c 2021
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520			\|a Background & Aims: Aldafermin, an engineered analog of fibroblast growth factor 19, inhibits bile acid synthesis and regulates metabolic homeostasis. We report results from a 24-week, phase 2 study, with serial liver biopsies, of patients with nonalcoholic steatohepatitis (NASH).Methods: We performed a double-blind study of 78 patients with NASH at 9 centers in the United States. Key inclusion criteria were biopsy-proven NASH with Nonalcoholic Fatty Liver Disease Activity Score ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content ≥8%, measured by magnetic resonance imaging-proton density fat fraction. Patients were randomly assigned (1:2) to groups given subcutaneous placebo (n = 25) or aldafermin 1 mg (n = 53) daily for 24 weeks. The primary outcome was change in absolute liver fat content from baseline at week 24. Secondary outcomes included serum markers and histologic measures of fibrosis improvement and NASH resolution.Results: At week 24, the aldafermin group had a significant reduction in absolute liver fat content (reduction of 7.7%) compared with placebo (reduction of 2.7%; difference, reduction of 5.0%; 95% confidence interval, reduction of 8.0%−1.9%; P = .002). Aldafermin produced significantly greater decreases in levels of 7α-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and neoepitope-specific N-terminal pro-peptide of type III collagen (Pro-C3) than placebo. Fibrosis improvement (≥1 stage) with no worsening of NASH was achieved in 38% of patients receiving aldafermin vs 18% of patients receiving placebo (P = .10). NASH resolution with no worsening of fibrosis was observed in 24% of patients given aldafermin vs 9% of patients given placebo (P = .20). Discontinuations due to adverse events occurred in no patients in the aldafermin group and 4% of patients in the placebo group.Conclusions: In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. ClinicalTrials.gov, Number: NCT02443116.
650		4	\|a Nonalcoholic Fatty Liver Disease
650		4	\|a NAFLD
650		4	\|a Metabolism
650		4	\|a Lipid
700	1		\|a Neff, Guy \|e verfasserin \|4 aut
700	1		\|a Guy, Cynthia D. \|e verfasserin \|4 aut
700	1		\|a Bashir, Mustafa R. \|e verfasserin \|4 aut
700	1		\|a Paredes, Angelo H. \|e verfasserin \|4 aut
700	1		\|a Frias, Juan P. \|e verfasserin \|4 aut
700	1		\|a Younes, Ziad \|e verfasserin \|4 aut
700	1		\|a Trotter, James F. \|e verfasserin \|4 aut
700	1		\|a Gunn, Nadege T. \|e verfasserin \|4 aut
700	1		\|a Moussa, Sam E. \|e verfasserin \|4 aut
700	1		\|a Kohli, Anita \|e verfasserin \|4 aut
700	1		\|a Nelson, Kristin \|e verfasserin \|4 aut
700	1		\|a Gottwald, Mildred \|e verfasserin \|4 aut
700	1		\|a Chang, William C.G. \|e verfasserin \|4 aut
700	1		\|a Yan, Andrew Z. \|e verfasserin \|4 aut
700	1		\|a DePaoli, Alex M. \|e verfasserin \|4 aut
700	1		\|a Ling, Lei \|e verfasserin \|4 aut
700	1		\|a Lieu, Hsiao D. \|e verfasserin \|4 aut
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allfields	10.1053/j.gastro.2020.08.004 doi (DE-627)ELV05249408X (ELSEVIER)S0016-5085(20)35018-6 DE-627 ger DE-627 rda eng 610 VZ 44.87 bkl Harrison, Stephen A. verfasserin aut Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background & Aims: Aldafermin, an engineered analog of fibroblast growth factor 19, inhibits bile acid synthesis and regulates metabolic homeostasis. We report results from a 24-week, phase 2 study, with serial liver biopsies, of patients with nonalcoholic steatohepatitis (NASH).Methods: We performed a double-blind study of 78 patients with NASH at 9 centers in the United States. Key inclusion criteria were biopsy-proven NASH with Nonalcoholic Fatty Liver Disease Activity Score ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content ≥8%, measured by magnetic resonance imaging-proton density fat fraction. Patients were randomly assigned (1:2) to groups given subcutaneous placebo (n = 25) or aldafermin 1 mg (n = 53) daily for 24 weeks. The primary outcome was change in absolute liver fat content from baseline at week 24. Secondary outcomes included serum markers and histologic measures of fibrosis improvement and NASH resolution.Results: At week 24, the aldafermin group had a significant reduction in absolute liver fat content (reduction of 7.7%) compared with placebo (reduction of 2.7%; difference, reduction of 5.0%; 95% confidence interval, reduction of 8.0%−1.9%; P = .002). Aldafermin produced significantly greater decreases in levels of 7α-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and neoepitope-specific N-terminal pro-peptide of type III collagen (Pro-C3) than placebo. Fibrosis improvement (≥1 stage) with no worsening of NASH was achieved in 38% of patients receiving aldafermin vs 18% of patients receiving placebo (P = .10). NASH resolution with no worsening of fibrosis was observed in 24% of patients given aldafermin vs 9% of patients given placebo (P = .20). Discontinuations due to adverse events occurred in no patients in the aldafermin group and 4% of patients in the placebo group.Conclusions: In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. ClinicalTrials.gov, Number: NCT02443116. Nonalcoholic Fatty Liver Disease NAFLD Metabolism Lipid Neff, Guy verfasserin aut Guy, Cynthia D. verfasserin aut Bashir, Mustafa R. verfasserin aut Paredes, Angelo H. verfasserin aut Frias, Juan P. verfasserin aut Younes, Ziad verfasserin aut Trotter, James F. verfasserin aut Gunn, Nadege T. verfasserin aut Moussa, Sam E. verfasserin aut Kohli, Anita verfasserin aut Nelson, Kristin verfasserin aut Gottwald, Mildred verfasserin aut Chang, William C.G. verfasserin aut Yan, Andrew Z. verfasserin aut DePaoli, Alex M. verfasserin aut Ling, Lei verfasserin aut Lieu, Hsiao D. verfasserin aut Enthalten in Gastroenterology Stanford, Calif. : HighWire Press, 1965 160 Online-Ressource (DE-627)270937293 (DE-600)1478699-0 (DE-576)078590221 1528-0012 nnns volume:160 GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.87 Gastroenterologie VZ AR 160
spelling	10.1053/j.gastro.2020.08.004 doi (DE-627)ELV05249408X (ELSEVIER)S0016-5085(20)35018-6 DE-627 ger DE-627 rda eng 610 VZ 44.87 bkl Harrison, Stephen A. verfasserin aut Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background & Aims: Aldafermin, an engineered analog of fibroblast growth factor 19, inhibits bile acid synthesis and regulates metabolic homeostasis. We report results from a 24-week, phase 2 study, with serial liver biopsies, of patients with nonalcoholic steatohepatitis (NASH).Methods: We performed a double-blind study of 78 patients with NASH at 9 centers in the United States. Key inclusion criteria were biopsy-proven NASH with Nonalcoholic Fatty Liver Disease Activity Score ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content ≥8%, measured by magnetic resonance imaging-proton density fat fraction. Patients were randomly assigned (1:2) to groups given subcutaneous placebo (n = 25) or aldafermin 1 mg (n = 53) daily for 24 weeks. The primary outcome was change in absolute liver fat content from baseline at week 24. Secondary outcomes included serum markers and histologic measures of fibrosis improvement and NASH resolution.Results: At week 24, the aldafermin group had a significant reduction in absolute liver fat content (reduction of 7.7%) compared with placebo (reduction of 2.7%; difference, reduction of 5.0%; 95% confidence interval, reduction of 8.0%−1.9%; P = .002). Aldafermin produced significantly greater decreases in levels of 7α-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and neoepitope-specific N-terminal pro-peptide of type III collagen (Pro-C3) than placebo. Fibrosis improvement (≥1 stage) with no worsening of NASH was achieved in 38% of patients receiving aldafermin vs 18% of patients receiving placebo (P = .10). NASH resolution with no worsening of fibrosis was observed in 24% of patients given aldafermin vs 9% of patients given placebo (P = .20). Discontinuations due to adverse events occurred in no patients in the aldafermin group and 4% of patients in the placebo group.Conclusions: In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. ClinicalTrials.gov, Number: NCT02443116. Nonalcoholic Fatty Liver Disease NAFLD Metabolism Lipid Neff, Guy verfasserin aut Guy, Cynthia D. verfasserin aut Bashir, Mustafa R. verfasserin aut Paredes, Angelo H. verfasserin aut Frias, Juan P. verfasserin aut Younes, Ziad verfasserin aut Trotter, James F. verfasserin aut Gunn, Nadege T. verfasserin aut Moussa, Sam E. verfasserin aut Kohli, Anita verfasserin aut Nelson, Kristin verfasserin aut Gottwald, Mildred verfasserin aut Chang, William C.G. verfasserin aut Yan, Andrew Z. verfasserin aut DePaoli, Alex M. verfasserin aut Ling, Lei verfasserin aut Lieu, Hsiao D. verfasserin aut Enthalten in Gastroenterology Stanford, Calif. : HighWire Press, 1965 160 Online-Ressource (DE-627)270937293 (DE-600)1478699-0 (DE-576)078590221 1528-0012 nnns volume:160 GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.87 Gastroenterologie VZ AR 160
allfields_unstemmed	10.1053/j.gastro.2020.08.004 doi (DE-627)ELV05249408X (ELSEVIER)S0016-5085(20)35018-6 DE-627 ger DE-627 rda eng 610 VZ 44.87 bkl Harrison, Stephen A. verfasserin aut Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background & Aims: Aldafermin, an engineered analog of fibroblast growth factor 19, inhibits bile acid synthesis and regulates metabolic homeostasis. We report results from a 24-week, phase 2 study, with serial liver biopsies, of patients with nonalcoholic steatohepatitis (NASH).Methods: We performed a double-blind study of 78 patients with NASH at 9 centers in the United States. Key inclusion criteria were biopsy-proven NASH with Nonalcoholic Fatty Liver Disease Activity Score ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content ≥8%, measured by magnetic resonance imaging-proton density fat fraction. Patients were randomly assigned (1:2) to groups given subcutaneous placebo (n = 25) or aldafermin 1 mg (n = 53) daily for 24 weeks. The primary outcome was change in absolute liver fat content from baseline at week 24. Secondary outcomes included serum markers and histologic measures of fibrosis improvement and NASH resolution.Results: At week 24, the aldafermin group had a significant reduction in absolute liver fat content (reduction of 7.7%) compared with placebo (reduction of 2.7%; difference, reduction of 5.0%; 95% confidence interval, reduction of 8.0%−1.9%; P = .002). Aldafermin produced significantly greater decreases in levels of 7α-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and neoepitope-specific N-terminal pro-peptide of type III collagen (Pro-C3) than placebo. Fibrosis improvement (≥1 stage) with no worsening of NASH was achieved in 38% of patients receiving aldafermin vs 18% of patients receiving placebo (P = .10). NASH resolution with no worsening of fibrosis was observed in 24% of patients given aldafermin vs 9% of patients given placebo (P = .20). Discontinuations due to adverse events occurred in no patients in the aldafermin group and 4% of patients in the placebo group.Conclusions: In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. ClinicalTrials.gov, Number: NCT02443116. Nonalcoholic Fatty Liver Disease NAFLD Metabolism Lipid Neff, Guy verfasserin aut Guy, Cynthia D. verfasserin aut Bashir, Mustafa R. verfasserin aut Paredes, Angelo H. verfasserin aut Frias, Juan P. verfasserin aut Younes, Ziad verfasserin aut Trotter, James F. verfasserin aut Gunn, Nadege T. verfasserin aut Moussa, Sam E. verfasserin aut Kohli, Anita verfasserin aut Nelson, Kristin verfasserin aut Gottwald, Mildred verfasserin aut Chang, William C.G. verfasserin aut Yan, Andrew Z. verfasserin aut DePaoli, Alex M. verfasserin aut Ling, Lei verfasserin aut Lieu, Hsiao D. verfasserin aut Enthalten in Gastroenterology Stanford, Calif. : HighWire Press, 1965 160 Online-Ressource (DE-627)270937293 (DE-600)1478699-0 (DE-576)078590221 1528-0012 nnns volume:160 GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.87 Gastroenterologie VZ AR 160
allfieldsGer	10.1053/j.gastro.2020.08.004 doi (DE-627)ELV05249408X (ELSEVIER)S0016-5085(20)35018-6 DE-627 ger DE-627 rda eng 610 VZ 44.87 bkl Harrison, Stephen A. verfasserin aut Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background & Aims: Aldafermin, an engineered analog of fibroblast growth factor 19, inhibits bile acid synthesis and regulates metabolic homeostasis. We report results from a 24-week, phase 2 study, with serial liver biopsies, of patients with nonalcoholic steatohepatitis (NASH).Methods: We performed a double-blind study of 78 patients with NASH at 9 centers in the United States. Key inclusion criteria were biopsy-proven NASH with Nonalcoholic Fatty Liver Disease Activity Score ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content ≥8%, measured by magnetic resonance imaging-proton density fat fraction. Patients were randomly assigned (1:2) to groups given subcutaneous placebo (n = 25) or aldafermin 1 mg (n = 53) daily for 24 weeks. The primary outcome was change in absolute liver fat content from baseline at week 24. Secondary outcomes included serum markers and histologic measures of fibrosis improvement and NASH resolution.Results: At week 24, the aldafermin group had a significant reduction in absolute liver fat content (reduction of 7.7%) compared with placebo (reduction of 2.7%; difference, reduction of 5.0%; 95% confidence interval, reduction of 8.0%−1.9%; P = .002). Aldafermin produced significantly greater decreases in levels of 7α-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and neoepitope-specific N-terminal pro-peptide of type III collagen (Pro-C3) than placebo. Fibrosis improvement (≥1 stage) with no worsening of NASH was achieved in 38% of patients receiving aldafermin vs 18% of patients receiving placebo (P = .10). NASH resolution with no worsening of fibrosis was observed in 24% of patients given aldafermin vs 9% of patients given placebo (P = .20). Discontinuations due to adverse events occurred in no patients in the aldafermin group and 4% of patients in the placebo group.Conclusions: In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. ClinicalTrials.gov, Number: NCT02443116. Nonalcoholic Fatty Liver Disease NAFLD Metabolism Lipid Neff, Guy verfasserin aut Guy, Cynthia D. verfasserin aut Bashir, Mustafa R. verfasserin aut Paredes, Angelo H. verfasserin aut Frias, Juan P. verfasserin aut Younes, Ziad verfasserin aut Trotter, James F. verfasserin aut Gunn, Nadege T. verfasserin aut Moussa, Sam E. verfasserin aut Kohli, Anita verfasserin aut Nelson, Kristin verfasserin aut Gottwald, Mildred verfasserin aut Chang, William C.G. verfasserin aut Yan, Andrew Z. verfasserin aut DePaoli, Alex M. verfasserin aut Ling, Lei verfasserin aut Lieu, Hsiao D. verfasserin aut Enthalten in Gastroenterology Stanford, Calif. : HighWire Press, 1965 160 Online-Ressource (DE-627)270937293 (DE-600)1478699-0 (DE-576)078590221 1528-0012 nnns volume:160 GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.87 Gastroenterologie VZ AR 160
allfieldsSound	10.1053/j.gastro.2020.08.004 doi (DE-627)ELV05249408X (ELSEVIER)S0016-5085(20)35018-6 DE-627 ger DE-627 rda eng 610 VZ 44.87 bkl Harrison, Stephen A. verfasserin aut Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis 2021 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background & Aims: Aldafermin, an engineered analog of fibroblast growth factor 19, inhibits bile acid synthesis and regulates metabolic homeostasis. We report results from a 24-week, phase 2 study, with serial liver biopsies, of patients with nonalcoholic steatohepatitis (NASH).Methods: We performed a double-blind study of 78 patients with NASH at 9 centers in the United States. Key inclusion criteria were biopsy-proven NASH with Nonalcoholic Fatty Liver Disease Activity Score ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content ≥8%, measured by magnetic resonance imaging-proton density fat fraction. Patients were randomly assigned (1:2) to groups given subcutaneous placebo (n = 25) or aldafermin 1 mg (n = 53) daily for 24 weeks. The primary outcome was change in absolute liver fat content from baseline at week 24. Secondary outcomes included serum markers and histologic measures of fibrosis improvement and NASH resolution.Results: At week 24, the aldafermin group had a significant reduction in absolute liver fat content (reduction of 7.7%) compared with placebo (reduction of 2.7%; difference, reduction of 5.0%; 95% confidence interval, reduction of 8.0%−1.9%; P = .002). Aldafermin produced significantly greater decreases in levels of 7α-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and neoepitope-specific N-terminal pro-peptide of type III collagen (Pro-C3) than placebo. Fibrosis improvement (≥1 stage) with no worsening of NASH was achieved in 38% of patients receiving aldafermin vs 18% of patients receiving placebo (P = .10). NASH resolution with no worsening of fibrosis was observed in 24% of patients given aldafermin vs 9% of patients given placebo (P = .20). Discontinuations due to adverse events occurred in no patients in the aldafermin group and 4% of patients in the placebo group.Conclusions: In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. ClinicalTrials.gov, Number: NCT02443116. Nonalcoholic Fatty Liver Disease NAFLD Metabolism Lipid Neff, Guy verfasserin aut Guy, Cynthia D. verfasserin aut Bashir, Mustafa R. verfasserin aut Paredes, Angelo H. verfasserin aut Frias, Juan P. verfasserin aut Younes, Ziad verfasserin aut Trotter, James F. verfasserin aut Gunn, Nadege T. verfasserin aut Moussa, Sam E. verfasserin aut Kohli, Anita verfasserin aut Nelson, Kristin verfasserin aut Gottwald, Mildred verfasserin aut Chang, William C.G. verfasserin aut Yan, Andrew Z. verfasserin aut DePaoli, Alex M. verfasserin aut Ling, Lei verfasserin aut Lieu, Hsiao D. verfasserin aut Enthalten in Gastroenterology Stanford, Calif. : HighWire Press, 1965 160 Online-Ressource (DE-627)270937293 (DE-600)1478699-0 (DE-576)078590221 1528-0012 nnns volume:160 GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.87 Gastroenterologie VZ AR 160
language	English
source	Enthalten in Gastroenterology 160 volume:160
sourceStr	Enthalten in Gastroenterology 160 volume:160
format_phy_str_mv	Article
bklname	Gastroenterologie
institution	findex.gbv.de
topic_facet	Nonalcoholic Fatty Liver Disease NAFLD Metabolism Lipid
dewey-raw	610
isfreeaccess_bool	false
container_title	Gastroenterology
authorswithroles_txt_mv	Harrison, Stephen A. @@aut@@ Neff, Guy @@aut@@ Guy, Cynthia D. @@aut@@ Bashir, Mustafa R. @@aut@@ Paredes, Angelo H. @@aut@@ Frias, Juan P. @@aut@@ Younes, Ziad @@aut@@ Trotter, James F. @@aut@@ Gunn, Nadege T. @@aut@@ Moussa, Sam E. @@aut@@ Kohli, Anita @@aut@@ Nelson, Kristin @@aut@@ Gottwald, Mildred @@aut@@ Chang, William C.G. @@aut@@ Yan, Andrew Z. @@aut@@ DePaoli, Alex M. @@aut@@ Ling, Lei @@aut@@ Lieu, Hsiao D. @@aut@@
publishDateDaySort_date	2021-01-01T00:00:00Z
hierarchy_top_id	270937293
dewey-sort	3610
id	ELV05249408X
language_de	englisch
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We report results from a 24-week, phase 2 study, with serial liver biopsies, of patients with nonalcoholic steatohepatitis (NASH).Methods: We performed a double-blind study of 78 patients with NASH at 9 centers in the United States. Key inclusion criteria were biopsy-proven NASH with Nonalcoholic Fatty Liver Disease Activity Score ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content ≥8%, measured by magnetic resonance imaging-proton density fat fraction. Patients were randomly assigned (1:2) to groups given subcutaneous placebo (n = 25) or aldafermin 1 mg (n = 53) daily for 24 weeks. The primary outcome was change in absolute liver fat content from baseline at week 24. Secondary outcomes included serum markers and histologic measures of fibrosis improvement and NASH resolution.Results: At week 24, the aldafermin group had a significant reduction in absolute liver fat content (reduction of 7.7%) compared with placebo (reduction of 2.7%; difference, reduction of 5.0%; 95% confidence interval, reduction of 8.0%−1.9%; P = .002). Aldafermin produced significantly greater decreases in levels of 7α-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and neoepitope-specific N-terminal pro-peptide of type III collagen (Pro-C3) than placebo. Fibrosis improvement (≥1 stage) with no worsening of NASH was achieved in 38% of patients receiving aldafermin vs 18% of patients receiving placebo (P = .10). NASH resolution with no worsening of fibrosis was observed in 24% of patients given aldafermin vs 9% of patients given placebo (P = .20). Discontinuations due to adverse events occurred in no patients in the aldafermin group and 4% of patients in the placebo group.Conclusions: In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. 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author	Harrison, Stephen A.
spellingShingle	Harrison, Stephen A. ddc 610 bkl 44.87 misc Nonalcoholic Fatty Liver Disease misc NAFLD misc Metabolism misc Lipid Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis
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topic_title	610 VZ 44.87 bkl Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver Disease NAFLD Metabolism Lipid
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title	Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis
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title_full	Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis
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author_browse	Harrison, Stephen A. Neff, Guy Guy, Cynthia D. Bashir, Mustafa R. Paredes, Angelo H. Frias, Juan P. Younes, Ziad Trotter, James F. Gunn, Nadege T. Moussa, Sam E. Kohli, Anita Nelson, Kristin Gottwald, Mildred Chang, William C.G. Yan, Andrew Z. DePaoli, Alex M. Ling, Lei Lieu, Hsiao D.
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title_sort	efficacy and safety of aldafermin, an engineered fgf19 analog, in a randomized, double-blind, placebo-controlled trial of patients with nonalcoholic steatohepatitis
title_auth	Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis
abstract	Background & Aims: Aldafermin, an engineered analog of fibroblast growth factor 19, inhibits bile acid synthesis and regulates metabolic homeostasis. We report results from a 24-week, phase 2 study, with serial liver biopsies, of patients with nonalcoholic steatohepatitis (NASH).Methods: We performed a double-blind study of 78 patients with NASH at 9 centers in the United States. Key inclusion criteria were biopsy-proven NASH with Nonalcoholic Fatty Liver Disease Activity Score ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content ≥8%, measured by magnetic resonance imaging-proton density fat fraction. Patients were randomly assigned (1:2) to groups given subcutaneous placebo (n = 25) or aldafermin 1 mg (n = 53) daily for 24 weeks. The primary outcome was change in absolute liver fat content from baseline at week 24. Secondary outcomes included serum markers and histologic measures of fibrosis improvement and NASH resolution.Results: At week 24, the aldafermin group had a significant reduction in absolute liver fat content (reduction of 7.7%) compared with placebo (reduction of 2.7%; difference, reduction of 5.0%; 95% confidence interval, reduction of 8.0%−1.9%; P = .002). Aldafermin produced significantly greater decreases in levels of 7α-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and neoepitope-specific N-terminal pro-peptide of type III collagen (Pro-C3) than placebo. Fibrosis improvement (≥1 stage) with no worsening of NASH was achieved in 38% of patients receiving aldafermin vs 18% of patients receiving placebo (P = .10). NASH resolution with no worsening of fibrosis was observed in 24% of patients given aldafermin vs 9% of patients given placebo (P = .20). Discontinuations due to adverse events occurred in no patients in the aldafermin group and 4% of patients in the placebo group.Conclusions: In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. ClinicalTrials.gov, Number: NCT02443116.
abstractGer	Background & Aims: Aldafermin, an engineered analog of fibroblast growth factor 19, inhibits bile acid synthesis and regulates metabolic homeostasis. We report results from a 24-week, phase 2 study, with serial liver biopsies, of patients with nonalcoholic steatohepatitis (NASH).Methods: We performed a double-blind study of 78 patients with NASH at 9 centers in the United States. Key inclusion criteria were biopsy-proven NASH with Nonalcoholic Fatty Liver Disease Activity Score ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content ≥8%, measured by magnetic resonance imaging-proton density fat fraction. Patients were randomly assigned (1:2) to groups given subcutaneous placebo (n = 25) or aldafermin 1 mg (n = 53) daily for 24 weeks. The primary outcome was change in absolute liver fat content from baseline at week 24. Secondary outcomes included serum markers and histologic measures of fibrosis improvement and NASH resolution.Results: At week 24, the aldafermin group had a significant reduction in absolute liver fat content (reduction of 7.7%) compared with placebo (reduction of 2.7%; difference, reduction of 5.0%; 95% confidence interval, reduction of 8.0%−1.9%; P = .002). Aldafermin produced significantly greater decreases in levels of 7α-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and neoepitope-specific N-terminal pro-peptide of type III collagen (Pro-C3) than placebo. Fibrosis improvement (≥1 stage) with no worsening of NASH was achieved in 38% of patients receiving aldafermin vs 18% of patients receiving placebo (P = .10). NASH resolution with no worsening of fibrosis was observed in 24% of patients given aldafermin vs 9% of patients given placebo (P = .20). Discontinuations due to adverse events occurred in no patients in the aldafermin group and 4% of patients in the placebo group.Conclusions: In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. ClinicalTrials.gov, Number: NCT02443116.
abstract_unstemmed	Background & Aims: Aldafermin, an engineered analog of fibroblast growth factor 19, inhibits bile acid synthesis and regulates metabolic homeostasis. We report results from a 24-week, phase 2 study, with serial liver biopsies, of patients with nonalcoholic steatohepatitis (NASH).Methods: We performed a double-blind study of 78 patients with NASH at 9 centers in the United States. Key inclusion criteria were biopsy-proven NASH with Nonalcoholic Fatty Liver Disease Activity Score ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content ≥8%, measured by magnetic resonance imaging-proton density fat fraction. Patients were randomly assigned (1:2) to groups given subcutaneous placebo (n = 25) or aldafermin 1 mg (n = 53) daily for 24 weeks. The primary outcome was change in absolute liver fat content from baseline at week 24. Secondary outcomes included serum markers and histologic measures of fibrosis improvement and NASH resolution.Results: At week 24, the aldafermin group had a significant reduction in absolute liver fat content (reduction of 7.7%) compared with placebo (reduction of 2.7%; difference, reduction of 5.0%; 95% confidence interval, reduction of 8.0%−1.9%; P = .002). Aldafermin produced significantly greater decreases in levels of 7α-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and neoepitope-specific N-terminal pro-peptide of type III collagen (Pro-C3) than placebo. Fibrosis improvement (≥1 stage) with no worsening of NASH was achieved in 38% of patients receiving aldafermin vs 18% of patients receiving placebo (P = .10). NASH resolution with no worsening of fibrosis was observed in 24% of patients given aldafermin vs 9% of patients given placebo (P = .20). Discontinuations due to adverse events occurred in no patients in the aldafermin group and 4% of patients in the placebo group.Conclusions: In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. ClinicalTrials.gov, Number: NCT02443116.
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title_short	Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis
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author2	Neff, Guy Guy, Cynthia D. Bashir, Mustafa R. Paredes, Angelo H. Frias, Juan P. Younes, Ziad Trotter, James F. Gunn, Nadege T. Moussa, Sam E. Kohli, Anita Nelson, Kristin Gottwald, Mildred Chang, William C.G. Yan, Andrew Z. DePaoli, Alex M. Ling, Lei Lieu, Hsiao D.
author2Str	Neff, Guy Guy, Cynthia D. Bashir, Mustafa R. Paredes, Angelo H. Frias, Juan P. Younes, Ziad Trotter, James F. Gunn, Nadege T. Moussa, Sam E. Kohli, Anita Nelson, Kristin Gottwald, Mildred Chang, William C.G. Yan, Andrew Z. DePaoli, Alex M. Ling, Lei Lieu, Hsiao D.
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doi_str	10.1053/j.gastro.2020.08.004
up_date	2024-07-06T23:11:05.401Z
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Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis

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