Clinical trialNCT02633956CompletedPhase 2Interventional

Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)

SponsorIntercept PharmaceuticalsEnrollment84Nonalcoholic Steatohepatitis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an open-label long-term safety extension (LTSE), will evaluate the effect of Obeticholic Acid, and the subsequent addition of statin therapy, on lipoprotein metabolism in subjects with nonalcoholic steatohepatitis (NASH) with fibrosis stage 1 to 4, but no evidence of hepatic decompensation.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

David Shapiro, MD
Intercept Pharmaceuticals
Study Director
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

22 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

St. Joseph'S Hospital and Medical Center
Phoenix, Arizona, United States
Scripps Clinic
La Jolla, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
Nature Coast Clinical Research
Inverness, Florida, United States
University of Miamai, Schiff Center for Liver Diseases
Miami, Florida, United States
South Florida Center of Gastroenterology
Wellington, Florida, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States
the Queen'S Medical Center - Liver Center
Honolulu, Hawaii, United States
Mercy Medical Center, Institute for Digestive Health & Liver Disease
Baltimore, Maryland, United States
Kansas City Research Institute
Kansas City, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Cumberland Research Associates, Llc
Fayetteville, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University Gastroenterology Liver Center
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Clinsearch
Chattanooga, Tennessee, United States
Texas Clinical Research Institute, Llc
Arlington, Texas, United States
Liver Associates of Texas, P.A.
Houston, Texas, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
Mcguire Dvamc
Richmond, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Atorvastatin →Obeticholic acid →Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 4 Dec 2015
Primary completion: 21 Mar 2017
Completion: 12 Mar 2018
Last update posted: 4 Jun 2018
Registered enrollment: 84
Registry id: NCT02633956

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.