A Proof-of-Concept, Open-Label Study Evaluating the Safety and Tolerability of Cilofexor in Subjects With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis

The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.

Start Date17 Oct 2019

Sponsor / Collaborator

Gilead Sciences, Inc.

NCT03987074 / CompletedPhase 2

A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH)

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

Start Date29 Jul 2019

Sponsor / Collaborator

Gilead Sciences, Inc.

[+1]

ACTRN12619000655145 / CompletedPhase 1

A Phase 1 Open-Label, Parallel-Group, Two-Treatment, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9674 and GS-0976 in Subjects with Normal Renal Function and Severe Renal Impairment

Start Date24 Jul 2019

Sponsor / Collaborator

Gilead Sciences, Inc.

100 Clinical Results associated with Cilofexor tromethamine

100 Translational Medicine associated with Cilofexor tromethamine

100 Patents (Medical) associated with Cilofexor tromethamine

Literatures (Medical) associated with Cilofexor tromethamine

01 Jan 2024·JHEP reports : innovation in hepatology

Combined inhibition of bile salt synthesis and intestinal uptake reduces cholestatic liver damage and colonic bile salts in mice

Article

Author: van de Graaf, Stan F J ; van Dasselaar, Rychon D J ; Oude Elferink, Ronald P J ; Beuers, Ulrich ; Nijmeijer, Bart A ; Bolt, Isabelle ; Kunst, Roni F

Background & Aims:

Intestine-restricted inhibitors of the apical sodium-dependent bile acid transporter (ASBT, or ileal bile acid transporter) are approved as treatment for several inheritable forms of cholestasis but are also associated with abdominal complaints and diarrhoea. Furthermore, blocking ASBT as a single therapeutic approach may be less effective in moderate to severe cholestasis. We hypothesised that interventions that lower hepatic bile salt synthesis in addition to intestinal bile salt uptake inhibition provide added therapeutic benefit in the treatment of cholestatic disorders. Here, we test combination therapies of intestinal ASBT inhibition together with obeticholic acid (OCA), cilofexor, and the non-tumorigenic fibroblast growth factor 15 (Fgf15)/fibroblast growth factor 19 (FGF19) analogue aldafermin in a mouse model of cholestasis.

Methods:

Wild-type male C57Bl6J/OlaHsd mice were fed a 0.05% 3,5-diethoxycarbonyl-1,4-dihydrocollidine (DDC) diet and received daily oral gavage with 10 mg/kg OCA, 30 mg/kg cilofexor, 10 mg/kg ASBT inhibitor (Linerixibat; ASBTi), or a combination. Alternatively, wild-type male C57Bl6J/OlaHsd mice were injected with adeno-associated virus vector serotype 8 (AAV8) to express aldafermin, to repress bile salt synthesis, or to control AAV8. During a 3-week 0.05% DDC diet, mice received daily oral gavage with 10 mg/kg ASBTi or placebo control.

Results:

Combination therapy of OCA, cilofexor, or aldafermin with ASBTi effectively reduced faecal bile salt excretion. Compared with ASBTi monotherapy, aldafermin + ASBTi further lowered plasma bile salt levels. Cilofexor + ASBTi and aldafermin + ASBTi treatment reduced plasma alanine transaminase and aspartate transaminase levels and fibrotic liver immunohistochemistry stainings. The reduction in inflammation and fibrogenesis in mice treated with cilofexor + ASBTi or aldafermin + ASBTi was confirmed by gene expression analysis.

Conclusions:

Combining pharmacological intestinal bile salt uptake inhibition with repression of bile salt synthesis may form an effective treatment strategy to reduce liver injury while dampening the ASBTi-induced colonic bile salt load.

Impact and Implications:

Combined treatment of intestinal ASBT inhibition with repression of bile salt synthesis by farnesoid X receptor agonism (using either obeticholic acid or cilofexor) or by expression of aldafermin ameliorates liver damage in cholestatic mice. In addition, compared with ASBT inhibitor monotherapy, combination treatments lower colonic bile salt load.

01 Nov 2023·JHEP reports : innovation in hepatology

Non-steroidal FXR agonist cilofexor improves cholestatic liver injury in the Mdr2-/- mouse model of sclerosing cholangitis

Article

Author: Minto, Wesley ; Hollenback, David ; Gupta, Ruchi ; Budas, Grant ; Fuchs, Claudia D ; Trauner, Michael ; Scharnagl, Hubert ; Liles, John T ; Stojakovic, Tatjana ; Sroda, Natalie

Background & Aims:

The nuclear receptor farnesoid X receptor (FXR) is a key regulator of hepatic bile acid (BA) and lipid metabolism, inflammation and fibrosis. Here, we aimed to explore the potential of cilofexor (GS-9674), a non-steroidal FXR agonist, as a therapeutic approach for counteracting features of cholestatic liver injury by evaluating its efficacy and mechanisms in the Mdr2/Abcb4 knockout (^-/-) mouse model of sclerosing cholangitis.

Methods:

FVB/N wild-type and Mdr2^-/- or BALB/c wild-type and Mdr2^-/- mice were treated with 0, 10, 30 or 90 mg/kg cilofexor by gavage every 24 h for 10 weeks. Serum biochemistry, gene expression profile, hydroxyproline content, and picrosirius red and F4/80 immunostaining, were investigated. Bile flow, biliary bicarbonate and BA output, and hepatic BA profile, were assessed.

Results:

Cilofexor treatment improved serum levels of aspartate aminotransferase, alkaline phosphatase as well as BAs in Mdr2^-/- animals. Hepatic fibrosis was improved, as reflected by the reduced picrosirius red-positive area and hydroxyproline content in liver sections of cilofexor-treated Mdr2^-/- mice. Intrahepatic BA concentrations were lowered in cilofexor-treated Mdr2^-/- mice, while hepatobiliary bile flow and bicarbonate output were increased.

Conclusion:

Collectively the current data show that cilofexor treatment improves cholestatic liver injury and decreases hepatic fibrosis in the Mdr2^-/- mouse model of sclerosing cholangitis.

Impact and implications:

Treatment with cilofexor, a non-steroidal farnesoid X receptor (FXR) agonist, improved histological features of sclerosing cholangitis, cholestasis and hepatic fibrosis in the Mdr2^-/- mouse model. These findings indicate, that pharmacological stimulation of intestinal FXR-mediated gut-liver signaling, via fibroblast growth factor 15 (thereby reducing bile acid synthesis), may be sufficient to attenuate cholestatic liver injury in the Mdr2^-/- mouse model of sclerosing cholangitis, thus arguing for potential therapeutic properties of cilofexor in cholestatic liver diseases.

01 Sep 2023·Journal of clinical pharmacology

Effect of Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Cilofexor, a Selective Nonsteroidal Farnesoid X Receptor Agonist.

Article

Author: Nelson, Cara ; Yue, Mun Sang ; Hsueh, Chia-Hsiang ; Billin, Andrew N ; Othman, Ahmed A ; Xiao, Deqing ; Watkins, Timothy R ; Younis, Islam R

Cilofexor is a nonsteroidal farnesoid X receptor agonist in clinical development for treatment of nonalcoholic steatohepatitis. This work characterized the pharmacokinetics, pharmacodynamics, safety, and tolerability of cilofexor in participants with normal hepatic function or hepatic impairment (HI). Participants with stable mild, moderate, or severe HI (Child-Pugh [CP] A, B, or C, respectively, [n = 10/group]) and healthy matched controls with normal hepatic function received a single oral dose of cilofexor (30 mg for CP-A or B; 10 mg for CP-C) with a standardized meal. Overall, 56 participants received cilofexor and completed the study. Cilofexor area under the plasma concentration-time curve was 76%, 2.5-fold, and 6.3-fold higher in participants with mild, moderate, or severe HI, respectively, relative to the area under the plasma concentration-time curve in matched participants with normal hepatic function. Cilofexor unbound fraction was 38%, 2-fold, and 3.16-fold higher in participants with mild, moderate, and severe HI, respectively, relative to participants with normal hepatic function. Moderate correlations were identified between cilofexor exposure and CP score or laboratory tests components of CP score. Serum 7α-hydroxy-4-cholesten-3-one and plasma fibroblast growth factor 19 were similar in participants with mild, moderate, or severe HI and participants with normal hepatic function. Cilofexor was generally well tolerated; all cilofexor-related adverse events were mild in severity. Cilofexor can be administered to patients with mild HI without dose adjustment. Caution and dose modification are warranted when administering cilofexor to patients with moderate or severe HI.

News (Medical) associated with Cilofexor tromethamine

12 Feb 2024

·medcitynews.com

Gilead’s $4.3B CymaBay Acquisition Adds Liver Disease Drug Under FDA Review

Gilead Sciences is acquiring biotech company CymaBay Therapeutics in a $4.3 billion deal that comes with a drug candidate currently under FDA review in a rare liver disease with few treatments. According to deal terms announced Monday, Gilead will pay $32.50 cash for each share of CymaBay. That price is a 27% premium to CymaBay’s closing stock price on Friday. The acquisition marks a comeback for the company and its drug, which just a few years ago faced an uncertain future amid safety questions. The main asset of CymaBay is seladelpar, a drug that the Newark, California-based company has developed for treating primary biliary cholangitis (PBC), a rare and progressive autoimmune condition that destroys the bile ducts of the liver. But this small molecule was at one time among the leading drug candidates for nonalcoholic steatohepatitis (NASH), a fatty liver disease that has no FDA-approved treatments. In 2019, a safety signal led CymaBay to stop a mid-stage test of seladelpar in NASH as well as a recently started study in primary sclerosing cholangitis, another chronic liver disorder. The FDA subsequently placed a formal clinical hold on the drug. The hold also stalled the development of the drug in PBC. The FDA cleared the company to resume testing of the drug in 2020, but CymaBay elected to continue development only in PBC. PBC is a chronic disorder that mainly affects women over the age of 40, impairing liver function. Common early symptoms include severe pruritus (itching) and fatigue. PBC can progress to cirrhosis and liver failure. The first-line drug treatment for PBC is ursodeoxycholic acid, or ursodiol, an old drug for dissolving gallstones that in 1996 won an additional approval as a treatment for PBC. The Intercept Pharmaceuticals drug Ocaliva was approved in 2016 as a second-line therapy for PBC. Intercept, which was acquired late last year by Italian company Alfasigma, reported $240.4 million in sales for the drug in the nine months ended Sept. 30, 2023. CymaBay’s seladelpar is a small molecule designed to bind to and activate peroxisome proliferator activated receptor delta (PPAR delta), a receptor that regulates genes involved in the synthesis of bile acids, metabolism, inflammation, and fibrosis. In its placebo-controlled Phase 3 clinical trial, results showed treatment with the drug led to statistically significant normalization of enzymes indicative of liver disease as well as improvement in pruritus. Late last year, CymaBay submitted a new drug application seeking approval of seladelpar as a treatment for patients who are inadequate responders to or intolerant of ursodiol. CymaBay announced Monday that the FDA will evaluate the application under priority review, setting an Aug. 14 target date for a regulatory decision. Gilead’s portfolio of liver disease drugs include the hepatitis B drugs Vemlidy and Viread as well as hepatitis C drug Harvoni. The Foster City, California-based drugmaker is also in the chase for NASH (now also called MASH, for metabolic associated steatohepatitis) with cilofexor and firsocostat, which are in Phase 2 testing as part of a combination treatment with Novo Nordisk’s semaglutide. “Building on the strong research and development work by the CymaBay team to date, we have the potential to address a significant unmet need for people living with PBC and expand on our existing broad range of transformational therapies,” Gilead Chairman and CEO Daniel O’Day said in a prepared statement. CymaBay licensed seladelpar from Johnson & Johnson in a 2006 deal. If it’s approved, J&J is in line to receive royalties from sales. The CymaBay pipeline also includes MBX-2982, a molecule in Phase 2a testing for treating hypoglycemia in patients with type 1 diabetes. In a note sent to investors, William Blair analyst Andy Hsieh wrote that the CymaBay acquisition validates the clinical performance and commercial potential of seladelpar in PBC. He called the acquisition “poetic closure” for the company following the molecule’s previous clinical trial setbacks “We commend management’s resilience and persistence that ultimately led to seladelpar demonstrating the best-in-class clinical profile in PBC, and we expect the drug to benefit thousands of patients living with PBC as soon as later this year,” Hsieh said. Hsieh said the Gilead offer is fair and it is unlikely another bidder will emerge. The transaction requires the majority of CymaBay shareholders to tender their shares. The companies expect to close the transaction in the current quarter.

Phase 2AcquisitionClinical ResultPhase 3Drug Approval

12 Feb 2024

·www.fiercebiotech.com

Gilead pays $4.3B for CymaBay, the biotech that never gave up on liver disease med

CymaBay Therapeutics CEO Sujal Shah said its time for Gilead Sciences to apply its regulatory and commercial expertise to advancing liver disease med seladelpar. Gilead Sciences is bolstering its liver disease portfolio with the $4.3 billion acquisition of CymaBay Therapeutics, specifically for the primary biliary cholangitis (PBC) med seladelpar. The deal follows a Big Pharma trend of picking up late-stage, validated assets. Seladelpar was submitted to the FDA to treat PBC with pruritus, or itching, without cirrhosis or with compensated cirrhosis in December 2023. The rare liver disease primarily affects women over 40 and is characterized by impaired bile flow and the accumulation of bile acids in the liver, causing an elevation of liver enzymes that can be dangerous. Seladelpar was granted a priority review for the condition with a due date of Aug. 14 for a decision, according to a separate update from CymaBay this morning. “We are looking forward to advancing seladelpar by leveraging Gilead’s long-standing expertise in treating and curing liver diseases,” said Gilead CEO Daniel O’Day in a Monday statement. “Building on the strong research and development work by the CymaBay team to date, we have the potential to address a significant unmet need for people living with PBC and expand on our existing broad range of transformational therapies.” This will not be new territory for Gilead, which has a deep portfolio of HIV meds and has also previously tested GS-9674 for PBC. The med, now known as cilofexor, was unsuccessful in PBC and the related disease primary sclerosing cholangitis. Gilead is now testing cilofexor in combination with Novo Nordisk’s semaglutide for metabolic dysfunction-associated steatohepatitis (MASH—previously known as nonalcoholic steatohepatitis or NASH). Seladelpar improved levels of serum alkaline phosphatase and bilirubin, as well as reduced itch, in a phase 3 trial that read out in September. The data teed up the regulatory filing. It wasn’t smooth sailing for the med through the clinic, with seladelpar failing in MASH in 2019. But CymaBay pressed on, culminating in today’s deal with Gilead. “Now that seladelpar has achieved priority review with the FDA, we are excited that Gilead, with its long-standing commitment to patients with liver disease, can apply its regulatory and commercial expertise to bring seladelpar as quickly as possible to people with PBC,” CymaBay CEO Sujal Shah said in a statement. The deal has been approved by members of each company’s board and is set to close in the first quarter. CymaBay will become a wholly owned subsidiary of Gilead at close. Gilead is paying $32.50 per share in cash, a 27% premium to CymaBay's closing price as of Feb. 9. CymaBay's shares climbed 24% in premarket trading Monday to $32 apiece, compared to $25.69 at close Friday. William Blair analysts said the Gilead deal validates the clinical performance and potential of seladelpar. "The acquisition by Gilead represents a poetic closure to the CymaBay story," the firm wrote, noting the company's difficult decision to cut the MASH indication after adverse events cropped up. "We commend management’s resilience and persistence that ultimately led to seladelpar demonstrating the best-in-class clinical profile in PBC, and we expect the drug to benefit thousands of patients living with PBC as soon as later this year." William Blair had previously assumed an acquisition price of $2.9 billion, calling the Gilead offer fair. The firm assumes that no other bidder will emerge with a better offer, and the deal will close as planned.

AcquisitionPhase 3Priority ReviewClinical Result

26 Jun 2023

·www.prnewswire.com

Ascletis Announces Poster Presentation of Phase II Study of ASC42 FXR Agonist for Functional Cure of Chronic Hepatitis B at EASL CONGRESS 2023

HANGZHOU and SHAOXING, China, June 25, 2023 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") today announces the poster presentation of ASC42, a novel farnesoid X receptor (FXR) agonist, in combination with PEGylated interferon (PEG-IFN) and entecavir (ETV) in chronic hepatitis B (CHB) patients with 12-week treatment at European Association for the Study of the Liver (EASL) CONGRESS 2023. The summary of the abstract is shown as below: Title: A phase 2 study of ASC42, a novel farnesoid X receptor (FXR) agonist, in combination with PEGylated interferon (PEG-IFN) and entecavir (ETV) in chronic hepatitis B patients with 12-week treatment Presenter: Jinzi J. Wu, Ph.D. Principal Investigator: Prof. Jinlin Hou, Nanfang Hospital of Southern Medical University Poster Number: SAT-201 Category: Viral Hepatitis B and D Study Design: This Phase 2 trial (NCT05107778) was a multi-center, randomized, single-blind, placebo-controlled study conducted in China. Forty-three HBeAg negative, hepatitis B virus (HBV) DNA Results: In total, 122, 119, and 107 adverse events (AEs) were reported in 10 mg ASC42, 15 mg ASC42 and PBO cohorts, respectively, and most AEs (94.3%) were mild (grade 1) or moderate (grade 2) in severity. One subject in 15 mg ASC42 cohort experienced a grade 3 serious AE (SAE) of liver function injury with a final outcome of recovered. Pruritus is the most common AE, and study drug-related pruritus was reported in 1 (6.7%), 7 (50%) and 0 (0%) subjects in 10 mg ASC42, 15 mg ASC42 and PBO cohorts, respectively. Pruritus rate of 10 mg ASC42 (6.7%) is lower than other FXR agonists in non-alcoholic steatohepatitis (NASH) patients. Conclusion: In CHB patients, 12-week treatment of 10 mg ASC42 in combination of PEG-IFN-α-2a and ETV was safe and well-tolerated and showed minimum and mild pruritus (6.7%). Previous study indicated that in healthy subjects, 14-day treatment of ASC42 alone demonstrated 471%~1,780% increase of fibroblast growth factor 19 (FGF19) and 53%~91% decrease of 7α-hydroxy-4-cholesten-3-one (C4) at a dose range of 5 mg~15 mg. Data suggest that at the therapeutic dose of 10 mg, the novel FXR agonist ASC42 is differentiated from other FXR agonists in terms of pruritus. [1]. Data on file [2]. Younossi Z.M., Ratziu V., Loomba R., et al. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial [J]. The Lancet, 2019, 394(10215): 2184-96.DOI: 10.1016/s0140-6736(19)33041-7 [3]. Lau G.K., Piratvisuth T., Luo K.X., et al. Peginterferon Alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B [J]. N Engl J Med, 2005, 352(26): 2682-95.DOI: 10.1056/NEJMoa043470 [4]. Loomba R., Noureddin M., Kowdley K.V., et al. Combination Therapies Including Cilofexor and Firsocostat for Bridging Fibrosis and Cirrhosis Attributable to NASH [J]. Hepatology, 2021, 73(2): 625-43.DOI: 10.1002/hep.31622 [5]. Anstee Q.M., Lucas K.J., Francque S., et al. Tropifexor plus cenicriviroc combination versus monotherapy in non-alcoholic steatohepatitis: Results from the Phase 2b TANDEM study [J]. Hepatology, 2023.DOI: 10.1097/hep.0000000000000439 About EASL EASL, the European Association for the Study of the Liver, founded in 1966, is a medical association dedicated to pursuing excellence in liver research, to the clinical practice of liver disorders, and to providing education to all those interested in hepatology. As of 2022, EASL serves 4,900 members from 112 countries. About Ascletis Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has three marketed products, i.e. ritonavir tablets, GANOVO® and ASCLEVIR®, and 23 drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (HBV functional cure), ASC10 and ASC11(oral small molecules for COVID-19 treatment), ASC40 (recurrent glioblastoma), ASC42 (PBC, primary biliary cholangitis), and ASC40 (acne). For more information, please visit . SOURCE Ascletis Pharma Inc.

Clinical ResultPhase 2Phase 3

100 Deals associated with Cilofexor tromethamine

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Cholangitis, Sclerosing	Phase 3	US	Gilead Sciences, Inc.	27 Mar 2019
Cholangitis, Sclerosing	Phase 3	JP	Gilead Sciences, Inc.	27 Mar 2019
Cholangitis, Sclerosing	Phase 3	AU	Gilead Sciences, Inc.	27 Mar 2019
Cholangitis, Sclerosing	Phase 3	AT	Gilead Sciences, Inc.	27 Mar 2019
Cholangitis, Sclerosing	Phase 3	BE	Gilead Sciences, Inc.	27 Mar 2019
Cholangitis, Sclerosing	Phase 3	CA	Gilead Sciences, Inc.	27 Mar 2019
Cholangitis, Sclerosing	Phase 3	DK	Gilead Sciences, Inc.	27 Mar 2019
Cholangitis, Sclerosing	Phase 3	FI	Gilead Sciences, Inc.	27 Mar 2019
Cholangitis, Sclerosing	Phase 3	FR	Gilead Sciences, Inc.	27 Mar 2019
Cholangitis, Sclerosing	Phase 3	DE	Gilead Sciences, Inc.	27 Mar 2019

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03890120 (CTgov)	Phase 3	Cholangitis, Sclerosing	419	Cilofexor (Cilofexor 100 mg (Blinded Phase))	hhftzlhdla(qmdzeyagya) = wbilcritef vrmwbfjjhl (irastdgull, yqyototkda - ywacnbufnw) View more	-	29 Nov 2023
				Placebo (Placebo (Blinded Phase))	hhftzlhdla(qmdzeyagya) = yaomsbidbk vrmwbfjjhl (irastdgull, sufpkzjzkk - iwnuezzlze) View more
NCT04060147 (CTgov)	Phase 1	Cholangitis, Sclerosing \| Fibrosis \| Compensated cirrhosis	11	Cilofexor	sjkvthyqul(ygykjeqmlr) = ngrhvuplxs teeiurfvlo (dpljrchjny, cwflpreqic - drzukvzotv) View more	-	27 Jul 2023
PRIMIS (EASL2022)	Not Applicable	Cholangitis, Sclerosing	11	Cilofexor 30 mg	fxigvubffs(infbvwgfuf) = pzzlfuolpp freoudyzeu (kevgrhatvs ) View more	Positive	23 Jun 2022
NCT03987074 (Pubmed \| J Hepatol) Manual	Phase 2	Nonalcoholic Steatohepatitis	108	Semaglutide+Cilofexor tromethamine	ujewdzpxls(pjblgtiehj) = Treatments were well tolerated - the incidence of adverse events was similar across groups (73-90%) and most events were gastrointestinal in nature. vopfrslfyg (fqzsogviqy ) View more	Positive	16 Apr 2022
				Semaglutide+Firsocostat+Cilofexor tromethamine
NCT02781584 (Pubmed \| Clin Gastroenterol Hepatol) Manual	Phase 2	Hypertriglyceridemia \| Nonalcoholic Steatohepatitis	66	Fenofibrate+Cilofexor tromethamine+FirsocostatFirsocostat	vlljtmnefg(snstbkgwpd) = most treatment-emergent adverse events were Grade 1 to 2 severity ijbtjzogpi (lrwqzkdqus ) View more	Positive	06 Jan 2022
				Icosapent Ethyl+Cilofexor tromethamine+Firsocostat
NCT03987074 (CTgov)	Phase 2	Nonalcoholic Steatohepatitis	109	Semaglutide (Semaglutide)	aposezkvzo(xetekeoxsh) = momzaazhrz twzekmblws (tqxicfsrom, npamryprra - zplxkqgebg) View more	-	15 Jul 2021
				Semaglutide+Firsocostat (Semaglutide + Firsocostat 20 mg)	aposezkvzo(xetekeoxsh) = dlrhtpgrpq twzekmblws (tqxicfsrom, qowvyqkuno - lzmsdeuzbn) View more
NCT03449446 (CTgov)	Phase 2	Nonalcoholic Steatohepatitis \| Fibrosis \| Compensated cirrhosis	395	Placebo to match SEL	qfaibijpuv(apkmcpbebx) = zfmkvpkkar txxvjmubhx (cjdzpbyxwf, bdqolldqso - waswktbshq) View more	-	03 Dec 2020
NCT02808312 (CTgov)	Phase 1	Cholangitis, Sclerosing \| Nonalcoholic Steatohepatitis	57	Cilofexor (Cohort 1: Mild Hepatic Impairment)	ledduukgcy(sybhmfxgam) = icksviyiba jozvpwoitb (buhxtxwatt, rscgprvnrk - wnqcyvxqxp) View more	-	30 Sep 2020
				Cilofexor (Cohort 1: Normal Hepatic Function)	ledduukgcy(sybhmfxgam) = loxxjdgnyd jozvpwoitb (buhxtxwatt, mpkggfaijo - azhunsqiek) View more
NCT02854605 (Pubmed \| Hepatology)	Phase 2	Nonalcoholic Steatohepatitis	140	Cilofexor 100 mg	znyrrcftuz(ylluznloqk) = wcbpnnejln wfjzewxrrq (yryuwkycoi )	-	01 Jul 2020
				Cilofexor 30 mg	znyrrcftuz(ylluznloqk) = mvegjgkuui wfjzewxrrq (yryuwkycoi )
NCT02943447 (CTgov)	Phase 2	Fibrosis \| Primary Biliary Cholangitis	71	Cilofexor (Blinded Study Phase: Cilofexor 100 mg)	juxflicyxm(daetwkijrb) = nnhqfcrnyy acdkrhtqnf (tlqwpbujcx, vdozdootqz - bncpsdyyrp) View more	-	13 Jan 2020
				Cilofexor (Blinded Study Phase: Cilofexor 30 mg)	juxflicyxm(daetwkijrb) = gtovelqfjw acdkrhtqnf (tlqwpbujcx, nrjjefylsu - ulyvbmfznl) View more

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