VK2809 A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF VK2809 ADMINISTERED FOR 52 WEEKS FOLLOWED BY A 4-WEEK OFF-DRUG PHASE IN SUBJECTS WITH BIOPSY PROVEN NON-ALCOHOLIC STEATOHEPATITIS WITH FIBROSIS - VOYAGE

开始日期2021-02-16

申办/合作机构

Viking Therapeutics, Inc.

NCT04173065

/ Completed临床2期

VK2809 A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 52 Weeks Followed by a 4-Week Off-Drug Phase in Subjects With Biopsy Proven Non-Alcoholic Steatohepatitis With Fibrosis

The study includes 52 weeks, double-blind treatment period. Clinic visits will occur at Randomization and every four weeks from Week 4 through Week 52 and through End of Study period. The study includes a post-dosing study visit that will occur 4 weeks after the last dose of study drug. This visit represents the End-of-Study Visit (Week 56 Visit). Three hundred thirty-seven subjects will be enrolled into five treatment arms and there will be an equal distribution of males and females in each treatment arm. Subjects will be stratified by gender, fibrosis stage, and diabetes status.

开始日期2019-11-15

申办/合作机构

Viking Therapeutics, Inc.

NCT02927184

/ Completed临床2期

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess The Efficacy, Safety, and Tolerability of VK2809 Administered for 12 Weeks Followed by a 4-Week Off-Drug Phase in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease

This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering LDL-C and liver fat content in patients with primary hypercholesterolemia and fatty liver disease. The primary efficacy endpoint is percent change from baseline LDL-C at the end of the treatment period (Week 12). Secondary endpoints include effects on liver fat content and other liver and lipid markers, as well as effects on safety and tolerability, and pharmacokinetic (PK) measurements.

开始日期2016-09-28

申办/合作机构

Viking Therapeutics, Inc.

100 项与 MB-07811 相关的临床结果

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100 项与 MB-07811 相关的转化医学

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100 项与 MB-07811 相关的专利（医药）

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项与 MB-07811 相关的文献（医药）

2025-02-01·Journal of Gastroenterology and Hepatology

Thyromimetics and MASLD: Unveiling the Novel Molecules Beyond Resmetirom

Review

作者: Ezhilarasan, Devaraj

ABSTRACTBackgroundResmetirom, the first FDA‐approved drug for nonalcoholic steatohepatitis (NASH) with fibrosis in obese patients, when combined with lifestyle modifications, improves NASH resolution and reduces fibrosis by at least one stage. Low thyroid hormone (T3) levels are linked to a higher risk of developing metabolic dysfunction‐associated steatotic liver disease (MASLD). Epidemiological studies have confirmed the positive correlation between hypothyroidism and MASLD. Unraveling the molecular mechanisms of T3 signaling pathways in MASLD will enhance the prospects of identifying effective and specific targets. Therefore, this review discusses the significant role of thyroid hormones in the homeostasis of fat metabolism and describes the possible molecular mechanisms of thyromimetics in the treatment of MASLD.MethodsA comprehensive search in PubMed and EMBASE was conducted using the keywords “thyromimetics and liver diseases,” “thyroid hormone and liver diseases,” “hypothyroidism and liver diseases,” “T3, T4 and liver disease,” and “resmetirom and liver disease.” Relevant papers published before October 2024 were included.ResultsT3 treatment enhances mitochondrial respiration, biogenesis, β‐oxidation, and mitophagy, reducing liver lipid accumulation. However, T3 treatment causes cardiotoxicity through thyroid hormone receptor (THR)α agonistic activity. To address this, molecules with high THRβ agonistic but lower THRα activity have been developed. Besides resmetirom, other THRβ agonists like TG68, CS27109, MB07811, and KB‐141 show promising results in experimental studies. These molecules upregulate THRβ target genes, activate genes for fatty acid β‐oxidation in mitochondria and fatty acid breakdown in peroxisomes, downregulate the genes involved in de novo lipogenesis, reduce inflammation by downregulating NF‐κB/JNK/STAT3 signaling pathways, and accelerate fibrosis resolution by downregulating the expressions of fibrosis marker genes in NASH liver tissue.ConclusionFuture clinical studies should thoroughly investigate THRβ agonists, including TG68, CS27109, MB07811, and KB‐141.

2024-12-01·Gastroenterology & hepatology

Results From the 52-Week Phase 2b VOYAGE Trial of VK2809 in Patients With Biopsy-Confirmed Non-Alcoholic Steatohepatitis and Fibrosis: A Randomized, Placebo-Controlled Trial.

Article

2024-05-14·ACS Omega

Molecular Dynamic Simulation To Reveal the Mechanism Underlying MGL-3196 Resistance to Thyroxine Receptor Beta

Article

作者: Lu, Yi ; Zhuang, Deyi ; Qian, Liling ; Chen, Chun

Thyroxine receptor beta (TRβ) is a ligand-dependent nuclear receptor that participates in regulating multiple biological processes, particularly playing an important role in lipid metabolism regulation. TRβ is currently a popular therapeutic target for nonalcoholic steatohepatitis (NASH), while no drugs have been approved to treat this disease. MGL-3196 (Resmetirom) is the first TRβ agonist that has succeeded in phase III clinical trials for the treatment of NASH; therefore, studying its molecular mechanism of action is of great significance. In this study, we employed molecular dynamic simulation to investigate the interaction mode between MGL-3196 and TRβ at the all-atom level. More importantly, by comparing the binding patterns of MGL-3196 in several prevalent TRβ mutants, it was identified that the mutations R243Q and H435R located, respectively, around and within the ligand-binding pocket of TRβ cause TRβ to be insensitive to MGL-3196. This indicates that patients with NASH carrying these two mutations may exhibit resistance to the medication of MGL-3196, thereby highlighting the potential impact of TRβ mutations on TRβ-targeted treatment of NASH and beyond.

183

项与 MB-07811 相关的新闻（医药）

2025-03-04

·PRNewswire

Viking Therapeutics to Participate at Upcoming Investor Conferences

SAN DIEGO, March 4, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that the company will participate at multiple upcoming investor conferences. Details of the company's participation are as follows: Leerink Partners Global Healthcare Conference 2025 Details: Viking management will participate in a fireside chat and in 1-on-1 meetings Conference Date: March 10-12, 2025 Fireside Chat Timing: 9:20 – 9:50 a.m. Eastern on Tuesday, March 11, 2025 Location: Miami, FL Jefferies Biotech on the Beach Summit Details: Viking management will participate in 1-on-1 meetings Conference Dates: March 11-12, 2025 Location: Miami, FL A live webcast of the Leerink presentation may be accessed via a link on the Viking Therapeutics website in the Investors & Media section under Webcasts. Additionally, a replay of the webcast will be available on the Viking website following the conference. About Viking Therapeutics, Inc. Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking's clinical programs include VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. Data from a Phase 1 and a Phase 2 trial evaluating VK2735 (dosed subcutaneously) for metabolic disorders demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. Concurrently, the company is evaluating an oral formulation of VK2735 in a Phase 1 trial. Viking is also developing VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders. The compound successfully achieved both the primary and secondary endpoints in a recently completed Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company's newest program is evaluating a series of internally developed dual amylin and calcitonin receptor agonists (or DACRAs) for the treatment of obesity and other metabolic disorders. In the rare disease space, Viking is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD). In a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD, VK0214 was shown to be safe and well-tolerated, while driving significant reductions in plasma levels of very long-chain fatty acids (VLCFAs) and other lipids, as compared to placebo. For more information about Viking Therapeutics, please visit . SOURCE Viking Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床结果临床2期

2025-02-25

·Endpoints

Lilly pays $10M upfront for Organovo’s FXR agonist program

Eli Lilly is buying Organovo’s farnesoid X receptor (FXR) agonist program, which includes a drug in Phase 2 development for ulcerative colitis and metabolic dysfunction-associated steatohepatitis (MASH), the biotech said Tuesday . The drugmaker will pay $9 million upfront plus $1 million in 15 months and up to $50 million in milestones, according to an SEC filing . Lilly is obtaining all worldwide rights to the program. Organovo’s share price $ONVO nearly tripled in early trading on Tuesday. The deal is remarkable because Intercept Pharmaceuticals’ attempts to pursue this mechanism in MASH ended in grave disappointment. The FDA rejected the company’s treatment, called Ocaliva, for the fatty liver disease — which used to be called NASH — in 2020 . A subsequent Phase 3 trial failed too . Since then, FXR agonism has been superseded as a MASH approach by other mechanisms like thyroid hormone receptor beta agonism (used by Madrigal’s approved Rezdiffra and Viking Therapeutics’ experimental VK2809, among others) and FGF21 agonism (used by assets which include Akero’s efruxifermin and 89bio’s pegozafermin). That said, it’s not clear that Lilly intends to pursue Organovo’s asset, called FXR314, in MASH. The only indication mentioned in Organovo’s statement is inflammatory bowel disease, and Lilly has not commented. However, Organovo has trialed the drug in the disorder. The company presented Phase 2 data in November that showed statistically significant reductions versus placebo in liver fat, a commonly used biomarker in early MASH trials. According to its website , it was actively seeking a partner for this indication.

临床2期临床3期临床结果临床失败

2025-02-06

·EndPoints

AstraZeneca cuts UK funding pledge; Viking says it has ‘enough’ API for trials

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. AstraZeneca said it is “very disappointed” in the UK government’s decision to cut its contribution to the pharma company’s site expansion in Speke, UK, CEO Pascal Soriot said during the company’s fourth-quarter earnings Thursday. “It was not possible for the government to justify it, which we don’t really understand. But you know, that’s business life,” he added. However, he also noted there’s no tension between AstraZeneca and the UK government. Nonetheless, the big pharma cut its investment pledge in the UK to £90 million from £150 million this week, after it also pulled out of its planned expansion for the Speke factory last month. Viking Therapeutics said it has “enough” supply of APIs for its two upcoming late-stage studies, CEO Brian Lian said during its Q4 earnings call Wednesday. Viking has a GLP-1/GIP agonist, dubbed VK2735, being investigated for weight loss, and a thyroid receptor β agonist, called VK2809, for NASH that are about to enter Phase 3 trials. As for its commercial-scale manufacturing needs, Lian said Viking is still working on a “set of agreements.” At the JP Morgan confab last month, the company said it was working “really hard” to secure a long-term manufacturing contract that includes fill-finish for VK2735 and other assets. Jabil has acquired CDMO Pharmaceutics International , the companies said Tuesday. This will add commercial production services for auto-injectors, pen injectors, inhalers and on-body pumps to Jabil’s offerings. CDMO Recipharm has implemented a new so-called modular filing line at its factory in Wasserburg, Germany, which can make a variety of products like syringes and vials, the company said Wednesday . Uniphar has launched three new factories to expand its global footprint, located in Raleigh, NC, Lelystad, Netherlands, and Dublin, Ireland, the company said Monday. Uniphar is a pharma consultant and medical device distributor. Three companies have joined forces to develop an RNA vaccine platform. Africa-based EVA Pharma, French company DNA Script and Belgium-headquartered Quantoom Biosciences signed a Memorandum of Understanding on the collaboration, according to a Wednesday release. Oman’s Ministry of Health signed purchase agreements with six Oman pharmaceutical manufacturers: Philex Pharmaceuticals, Menagene Pharmaceuticals, Opal Bio Pharma, Dhofar Pharma, Izz Pharma and Health Supplies Factory. The agreements will help local production of medicines in Oman.

疫苗并购

100 项与 MB-07811 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15137

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
纤维化	临床2期	墨西哥	Viking Therapeutics, Inc.	2019-11-15
纤维化	临床2期	美国	Viking Therapeutics, Inc.	2019-11-15
非酒精性脂肪性肝炎	临床2期	美国	Viking Therapeutics, Inc.	2019-11-15
非酒精性脂肪性肝炎	临床2期	法国	Viking Therapeutics, Inc.	2019-11-15
非酒精性脂肪性肝炎	临床2期	比利时	Viking Therapeutics, Inc.	2019-11-15
非酒精性脂肪性肝炎	临床2期	墨西哥	Viking Therapeutics, Inc.	2019-11-15
非酒精性脂肪性肝炎	临床2期	波多黎各	Viking Therapeutics, Inc.	2019-11-15
原发性高胆固醇血症	临床前	美国	Ligand Pharmaceuticals, Inc.	2009-04-01
代谢功能障碍相关的脂肪肝病	药物发现	美国	Viking Therapeutics, Inc.	2016-09-28
原发性高胆固醇血症	药物发现	美国	Ligand Pharmaceuticals, Inc.	2009-04-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04173065 (VOYAGE, PRNewswire) 人工标引	临床2期	非酒精性脂肪性肝炎	-	VK2809	(範觸襯餘獵願鏇鑰範遞) = 簾艱網淵簾糧壓餘選夢鏇鑰糧廠衊繭築衊選膚 (醖衊糧選構憲醖餘壓壓 ) 更多	积极	2024-11-19
				Placebo	(範觸襯餘獵願鏇鑰範遞) = 齋淵選鏇醖範顧顧鹹構鏇鑰糧廠衊繭築衊選膚 (醖衊糧選構憲醖餘壓壓 ) 更多
NCT04173065 (VOYAGE, PRNewswire) 人工标引	临床2期	非酒精性脂肪性肝炎	-	VK2809 (1 mg QD)	(夢窪願構淵衊壓網艱窪) = 夢齋選淵簾獵鏇艱醖窪憲簾膚壓鹹簾憲鹽積範 (網憲觸鑰選築獵壓範範 ) 更多	积极	2024-06-04
				VK2809 (2.5 mg QD)	(夢窪願構淵衊壓網艱窪) = 憲壓簾鬱積夢襯窪夢壓憲簾膚壓鹹簾憲鹽積範 (網憲觸鑰選築獵壓範範 ) 更多
EASL2020	临床2期	代谢功能障碍相关的脂肪肝病	-	VK2809 5 mg QD	範鑰觸構齋遞衊顧願構(築餘簾構願範範蓋鬱鑰) = VK2809 was well-tolerated in this study; no serious adverse events were reported in any cohort 鹹遞鹹憲餘壓遞餘膚選 (鑰獵餘淵鹹範製鬱顧鹽 )	积极	2020-08-27
				VK2809 10 mg QOD
EASL2019	临床2期	代谢功能障碍相关的脂肪肝病	-	VK2809 5 mg QD	蓋範鹽艱簾鬱獵遞鹽廠(鑰範鹽選醖構觸遞鏇簾) = 網蓋範鑰構網獵鏇餘膚鑰齋鑰鏇窪齋製網襯鏇 (憲簾鏇鬱繭醖齋壓簾網 ) 更多	-	2019-04-11
				VK2809 10 mg QOD	蓋範鹽艱簾鬱獵遞鹽廠(鑰範鹽選醖構觸遞鏇簾) = 築鏇鹹積製淵遞衊憲選鑰齋鑰鏇窪齋製網襯鏇 (憲簾鏇鬱繭醖齋壓簾網 ) 更多