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Clinical trialNCT00501592CompletedPhase 2Interventional

Study of INT-747 in Patients With Diabetes and Presumed NAFLD

SponsorIntercept PharmaceuticalsEnrollment64Diabetes Mellitus, Type IIFatty Liver
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following: * The safety and tolerability of multiple doses of INT 747; * The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and glucose homeostasis; * Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function and inflammation, and; * Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic acid (6-EDCA) and tauro 6-ECDCA.

Investigators

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

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

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

United States
  • Profil Institute for Clinical Research, Inc.

    Chula Vista, California, United States

  • Uc San Diego Vamc

    San Diego, California, United States

  • Diabetes & Glandular Disease Research Associates, Inc.

    San Antonio, Texas, United States

  • Virginia Commonwelath University

    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.

INT-747Placebo
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
31 Jul 2007
Primary completion
28 Feb 2009
Completion
30 Apr 2009
Last update posted
20 Apr 2012
Registered enrollment
64
Registry id
NCT00501592

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.