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2-Week Study In People With Nonalcoholic Fatty Liver Disease

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Non-alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis

Treatments

Drug: Placebo
Drug: PF-06865571

Study type

Interventional

Funder types

Industry

Identifiers

NCT03513588
C2541005

Details and patient eligibility

About

2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging procedures will be performed.

Enrollment

48 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • controlled attenuation parameter greater than or equal to 260 dB/m via FibroScan
  • liver fat greater than or equal to 6% via MRI

Exclusion criteria

  • Chronic liver disease
  • Type 2 diabetes requiring drug treatment
  • Unable to undergo MRI
  • History of heart attack or stroke

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
PF-06865571 100 mg
Experimental group
Treatment:
Drug: PF-06865571
Drug: PF-06865571
PF-06865571 600 mg
Experimental group
Treatment:
Drug: PF-06865571
Drug: PF-06865571

Trial documents
2

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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