NCT03513588

2-Week Study In People With Nonalcoholic Fatty Liver Disease

A PHASE 1B, RANDOMIZED, DOUBLE-BLIND (SPONSOR-OPEN), PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACODYNAMICS AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF- 06865571 FOR 2 WEEKS IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-alcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Placebo	tablet, 0 mg, 14 days, every 12 hours
DRUG	PF-06865571	tablet, 50 mg, 14 days, every 12 hours
DRUG	PF-06865571	tablet, 300 mg, 14 days, every 12 hours

Timeline

• Start date: 2018-06-21
• Primary completion: 2019-03-08
• Completion: 2019-04-04
• First posted: 2018-05-01
• Last updated: 2020-03-13
• Results posted: 2020-03-13

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study