2-Week Study In People With Nonalcoholic Fatty Liver Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/28/2019 |
| Start Date: | June 21, 2018 |
| End Date: | April 11, 2019 |
| Contact: | Pfizer CT.gov Call Center |
| Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
| Phone: | 1-800-718-1021 |
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
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.
placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging
procedures will be performed.
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
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