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Completed Phase 2 Interventional Results available

A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients

ClinicalTrials.gov ID: NCT02516605

Public ClinicalTrials.gov record NCT02516605. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 24, 2026, 9:32 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multi-part, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Primary Biliary Cholangitis

Study identification

NCT ID
NCT02516605
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
61 participants

Conditions and interventions

Interventions

  • Part 1: LJN452 Drug
  • Part 1: Placebo Drug
  • Part 2: LJN452 Dose level 1 Drug
  • Part 2: Placebo Drug
  • Part 2: LJN452 Dose level 2 Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 8, 2015
Primary completion
Aug 1, 2018
Completion
Aug 1, 2018
Last update posted
Jan 4, 2021

2015 – 2018

United States locations

U.S. sites
9
U.S. states
7
U.S. cities
9
Facility City State ZIP Site status
Novartis Investigative Site Rialto California 92377
Novartis Investigative Site Miami Florida 33136
Novartis Investigative Site Atlanta Georgia 30308
Novartis Investigative Site Marietta Georgia 30060
Novartis Investigative Site Chicago Illinois 60612
Novartis Investigative Site Manhasset New York 11030
Novartis Investigative Site Dallas Texas 75390
Novartis Investigative Site San Antonio Texas 78215
Novartis Investigative Site Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02516605, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 4, 2021 · Synced Jul 24, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02516605 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →