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Effects of ACC Inhibitor on Lipid and Lipoprotein Metabolism

NCT04395950 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-08-25

No results posted yet for this study

Summary

The purpose of this study is to assess the effects of an investigational drug, PF-05221304 (PF'1304) on the way the liver handles fat. The planned study will identify why the fat in the blood increases at the same time this drug reduces fat in the liver. The study will have two treatment periods of 6 weeks each, separated by a 3 week rest period with no treatment. The subjects will receive the active drug in one of the 6 week treatment periods and a placebo in the other 6 week period. The investigators will know when the subjects are receiving active treatment or placebo, but the subject will not know.

Conditions

  • NASH (Nonalcoholic Steatohepatitis)
  • NAFLD (Nonalcoholic Fatty Liver Disease)

Interventions

DRUG

PF-05221304

PF-05221304 10 mg daily (two 5mg tablets daily in the morning for 6 weeks)

DRUG

Placebo

Placebo two tablets daily in the morning for 6 weeks

Sponsors & Collaborators

Principal Investigators

  • Henry Ginsberg, MD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2021-08-19
Completion
2021-08-19
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04395950 on ClinicalTrials.gov