Who is sponsoring NCT03517540?

NCT03517540 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT03517540?

Interventions in NCT03517540: Tropifexor (LJN452), Cenicriviroc (CVC).

What condition does NCT03517540 study?

NCT03517540 studies Non-alcoholic Steatohepatitis (NASH).

Is NCT03517540 still recruiting?

NCT03517540 is currently completed. Last updated 29 April 2022.

Are results published for NCT03517540?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-04-29 · How we verify

NCT03517540: TANDEM

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

Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis

Completed Phase 2 Results posted Last updated 29 April 2022

What this trial tests

Phase 2 trial testing Tropifexor (LJN452) in Non-alcoholic Steatohepatitis (NASH) in 193 participants. Completed in 15 October 2020.

Timeline

11 September 2018

Primary endpoint
15 September 2020

15 October 2020

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	193
Start date	11 September 2018
Primary completion	15 September 2020
Estimated completion	15 October 2020
Sites	65 locations across France, Italy, Russia, Turkey (Türkiye), India, Belgium, United Kingdom, Germany

Drugs / interventions tested

Tropifexor (LJN452) — full drug profile →
Cenicriviroc (CVC) — full drug profile →

Conditions studied

Non-alcoholic Steatohepatitis (NASH) — all drugs for Non-alcoholic Steatohepatitis (NASH) →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Non-alcoholic Steatohepatitis (NASH). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events Primary · AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks

Occurrence of adverse events and serious adverse events Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and then up to 66 weeks

Number of participants with at least one Adverse Event (AE)

Group	Value	95% CI
Arm A: Tropifexor (LJN452) - Dose 1	42
Arm B: Cenicriviroc (CVC)	41
Arm C: Tropifexor (LJN452) Dose 1 + CVC	40
Arm D: Tropifexor Dose 2 + CVC	42

Number of participants with at least one Serious Adverse Events (SAEs)

Group	Value	95% CI
Arm A: Tropifexor (LJN452) - Dose 1	5
Arm B: Cenicriviroc (CVC)	3
Arm C: Tropifexor (LJN452) Dose 1 + CVC	4
Arm D: Tropifexor Dose 2 + CVC	10

Deaths

Group	Value	95% CI
Arm A: Tropifexor (LJN452) - Dose 1	0
Arm B: Cenicriviroc (CVC)	0
Arm C: Tropifexor (LJN452) Dose 1 + CVC	0
Arm D: Tropifexor Dose 2 + CVC	0

Proportion of Participants Who Have at Least a One Point Improvement in Fibrosis Secondary · baseline to 48 Weeks

Efficacy of tropifexor + CVC in patients with Nonalcoholic steatohepatitis (NASH) with fibrosis stage F2/F3 as assessed by histological improvement after 48 weeks of treatment compared to monotherapies (tropifexor and CVC) compared to baseline biopsy

Group	Value	95% CI
Arm A: Tropifexor (LJN452) - Dose 1	10
Arm B: Cenicriviroc (CVC)	12
Arm C: Tropifexor (LJN452) Dose 1 + CVC	11
Arm D: Tropifexor Dose 2 + CVC	13

Proportion of Participants With Resolution of Steatohepatitis Secondary · baseline to 48 weeks

Group	Value	95% CI
Arm A: Tropifexor (LJN452) - Dose 1	8
Arm B: Cenicriviroc (CVC)	8
Arm C: Tropifexor (LJN452) Dose 1 + CVC	5
Arm D: Tropifexor Dose 2 + CVC	9

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tropifexor 140mg

Serious: 5/50 (10%)

Deaths: 0/50

CVC 150mg

Serious: 3/48 (6%)

Deaths: 0/48

Tropifexor 140mcg + CVC 150mg

Serious: 4/47 (9%)

Deaths: 0/47

Tropifexor 90 mg + CVC 150 mg

Serious: 10/48 (21%)

Deaths: 0/48

Serious adverse events (27 terms)

Reaction	System	Tropifexor 140mg	CVC 150mg	Tropifexor 140mcg + CVC 15…	Tropifexor 90 mg + CVC 150…
COVID-19	Infections and infestations	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—
Duodenal ulcer	Gastrointestinal disorders	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—
Oesophageal ulcer	Gastrointestinal disorders	—	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—
Biliary dyskinesia	Hepatobiliary disorders	—	—	—	—
Gallbladder polyp	Hepatobiliary disorders	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—
COVID-19 pneumonia	Infections and infestations	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—
Anaesthetic complication	Injury, poisoning and procedural complications	—	—	—	—
Cervical vertebral fracture	Injury, poisoning and procedural complications	—	—	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—	—	—
Spinal compression fracture	Injury, poisoning and procedural complications	—	—	—	—
Euglycaemic diabetic ketoacidosis	Metabolism and nutrition disorders	—	—	—	—
Spondylitis	Musculoskeletal and connective tissue disorders	—	—	—	—
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—
Depression suicidal	Psychiatric disorders	—	—	—	—
Benign prostatic hyperplasia	Reproductive system and breast disorders	—	—	—	—

Other adverse events (29 terms — click to expand)

Reaction	System	Tropifexor 140mg	CVC 150mg	Tropifexor 140mcg + CVC 15…	Tropifexor 90 mg + CVC 150…
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Asthenia	General disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—
Cataract	Eye disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Ear infection	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—

Most-reported serious reactions: COVID-19, Coronary artery disease, Myocardial infarction, Duodenal ulcer, Gastritis, Oesophageal ulcer, Pancreatitis acute, Non-cardiac chest pain.

Data from ClinicalTrials.gov NCT03517540 adverse events section.

Sponsor's own description

The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.

Publications & conference data

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

CCL5/CCR5 axis in human diseases and related treatments.
Zeng Z, Lan T, Wei Y, Wei X. · · 2022 · cited 254× · PMID 34514075 · DOI 10.1016/j.gendis.2021.08.004
Targeted therapeutics and novel signaling pathways in non-alcohol-associated fatty liver/steatohepatitis (NAFL/NASH).
Xu X, Poulsen KL, Wu L, Liu S, et al · · 2022 · cited 235× · PMID 35963848 · DOI 10.1038/s41392-022-01119-3
Macrophages in obesity and non-alcoholic fatty liver disease: Crosstalk with metabolism.
Lefere S, Tacke F. · · 2019 · cited 209× · PMID 32149275 · DOI 10.1016/j.jhepr.2019.02.004
Farnesoid X receptor (FXR): Structures and ligands.
Jiang L, Zhang H, Xiao D, Wei H, et al · · 2021 · cited 173× · PMID 33995909 · DOI 10.1016/j.csbj.2021.04.029
Targeting the CCL2/CCR2 Axis in Cancer Immunotherapy: One Stone, Three Birds?
Fei L, Ren X, Yu H, Zhan Y. · · 2021 · cited 172× · PMID 34804061 · DOI 10.3389/fimmu.2021.771210
Treatments for NAFLD: State of Art.
Mantovani A, Dalbeni A. · · 2021 · cited 147× · PMID 33652942 · DOI 10.3390/ijms22052350
Combination therapy for non-alcoholic steatohepatitis: rationale, opportunities and challenges.
Dufour JF, Caussy C, Loomba R. · · 2020 · cited 145× · PMID 32381514 · DOI 10.1136/gutjnl-2019-319104
Novel therapeutic targets for cholestatic and fatty liver disease.
Trauner M, Fuchs CD. · · 2022 · cited 141× · PMID 34615727 · DOI 10.1136/gutjnl-2021-324305

Verify or expand the search:

Other trials of Tropifexor (LJN452)

Trials testing the same drug.

NCT02855164 — Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH) · Phase 2 · terminated

Other recruiting trials for Non-alcoholic Steatohepatitis (NASH)

Currently open trials in the same condition.

NCT05384652 — Simultaneous Quantification of Liver Fat Content, Fatty Acid Composition, and Fibrosis Using Spin-lock MRI for Steatohep · active not recruiting
NCT04820036 — A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG) · NA · active not recruiting
NCT02754037 — Non-alcoholic Fatty Liver Disease Parametric PET (FLiPP) Study · 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 NCT03517540 (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: 29 April 2022

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/NCT03517540.

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