NCT03681457 is a Phase 1 clinical trial of LJN452 in Non-alcoholic Fatty Liver Disease, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT03681457?

NCT03681457 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT03681457?

Interventions in NCT03681457: LJN452.

What condition does NCT03681457 study?

NCT03681457 studies Non-alcoholic Fatty Liver Disease.

Is NCT03681457 still recruiting?

NCT03681457 is currently completed. Last updated 14 December 2020.

Last reviewed 2020-12-14 · How we verify

NCT03681457

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects

Completed Phase 1 Last updated 14 December 2020

What this trial tests

Phase 1 trial testing LJN452 in Non-alcoholic Fatty Liver Disease in 42 participants. Completed in 25 September 2019.

Timeline

24 September 2018

Primary endpoint
25 September 2019

25 September 2019

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	24 September 2018
Primary completion	25 September 2019
Estimated completion	25 September 2019
Sites	3 locations across United States

Drugs / interventions tested

LJN452 — full drug profile →

Conditions studied

Non-alcoholic Fatty Liver Disease — all drugs for Non-alcoholic Fatty Liver Disease →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 70, any sex, with Non-alcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment. The results of this study will support treatment and dosing decisions for patients with varying degrees of hepatic impairment.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Current Therapeutical Approaches Targeting Lipid Metabolism in NAFLD.
Vitulo M, Gnodi E, Rosini G, Meneveri R, et al · · 2023 · cited 21× · PMID 37628929 · DOI 10.3390/ijms241612748
Linking Nonalcoholic Fatty Liver Disease and Brain Disease: Focusing on Bile Acid Signaling.
Ren ZL, Li CX, Ma CY, Chen D, et al · · 2022 · cited 18× · PMID 36361829 · DOI 10.3390/ijms232113045
Pathogenesis and Therapeutic Strategies Related to Non-Alcoholic Fatty Liver Disease.
Teng T, Qiu S, Zhao Y, Zhao S, et al · · 2022 · cited 18× · PMID 35887189 · DOI 10.3390/ijms23147841

Verify or expand the search:

Other trials of LJN452

Trials testing the same drug.

NCT02713243 — To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea. · Phase 2 · completed

Other recruiting trials for Non-alcoholic Fatty Liver Disease

Currently open trials in the same condition.

NCT07358546 — A Study of Efimosfermin Alfa in Adults With Hepatic Impairment · Phase 1 · recruiting
NCT07335198 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a · Phase 1 · recruiting
NCT07221188 — A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or · Phase 3 · recruiting
NCT07221227 — A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH · Phase 3 · recruiting
NCT07514377 — JiGenerations Health Cohort Study：Parental Exposure and Intergenerational Health in China · active not recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03681457 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 14 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03681457.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing