Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

Summary

This is a Phase 2 multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety and efficacy of TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH), a type of fatty liver disease. Subjects will be randomly assigned to 1 of 2 treatment groups (TVB-2640 at one of three doses or placebo). Following randomization, subjects will begin the 12-week treatment period and will receive once daily TVB-2640 or placebo.

Timeline

Start

2019-03-22

Primary completion

2021-10-02

Completion

2021-10-02

Outcome

Mixed primary results

paper The primary end points of this study were safety and relative change in liver fat after treatment. PMID 34310978 ↗

paper TVB-2640 reduced liver fat by 9.6% in the 25-mg cohort (n = 30; least squares mean: -15.5%; 95% confidence interval, -31.3 to -0.23; P = .053) PMID 34310978 ↗

paper and 28.1% in the 50-mg cohort (n = 28; least squares mean: -28.0%; 95% confidence interval, -44.5 to -11.6; P = .001). PMID 34310978 ↗

Publications

• Loomba R, Mohseni R, Lucas KJ, Gutierrez JA, Perry RG, Trotter JF, Rahimi RS, Harrison SA, Ajmera V, Wayne JD, O'Farrell M, McCulloch W, Grimmer K, Rinella M, Wai-Sun Wong V, Ratziu V, Gores GJ, Neuschwander-Tetri BA, Kemble G. TVB-2640 (FASN Inhibitor) for the Treatment of Nonalcoholic Steatohepatitis: FASCINATE-1, a Randomized, Placebo-Controlled Phase 2a Trial. Gastroenterology. 2021 Nov;161(5):1475-1486. doi: 10.1053/j.gastro.2021.07.025. Epub 2021 Jul 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Denifanstat	Small molecule	25 mg	Oral
Subject	Denifanstat	Small molecule	50 mg	Oral
Subject	Denifanstat	Small molecule	75 mg	Oral

Indications