If you have type 2 diabetes, you may also have Non-Alcoholic Fatty Liver Disease (NAFLD). NAFLD is a condition in which fat builds up in your liver, even if you drink little or no alcohol. NAFLD can often develop without any symptoms, so people may not be aware they have fatty liver.
A new clinical research study is assessing a study drug for people with type 2 diabetes and NAFLD.
This clinical research study may be an option for men or women, unable to bear children, who:
- Are aged between 18 and 70 years old.
- Are being treated for type 2 diabetes with at least 500mg metformin daily.
- Have a waist measurement of at least 40 in/102 cm (men) or 35 in/89 cm (women)
Facts: Obesity and physical inactivity are risk factors for the development of T2DM and NAFLD3
Study Drug
- PF-06835919 has the potential to reduce liver fat and biomarkers of inflammation.
- In a Phase 2 study (C1061003), PF-06835919 300 mg resulted in reductions in liver fat over a 6-week period.
- In three completed clinical studies, PF-06835919 was well tolerated, with an acceptable safety profile.
- 150 mg and 300 mg of PF-06835919 will be compared with placebo in a 1:1:1 ratio in this clinical research study.
Study Objectives
2 QD dose levels of PF-06835919 vs. placebo
Primary objective:
- Effect on whole liver fat (measured by MRI-PDFF)
- Effect on HbA1c
Secondary objectives:
- Safety and tolerability
- Effect on hs-CRP
- Effect on glycemic metabolism
- Effect on ALT
Study Design
What is expected of study participants?
Study participants must:
- Attend at least 12* study site visits during the screening, treatment and follow-up periods.
- Take the study drug or placebo tablets every morning for 16 weeks.
- Follow dietary and lifestyle restrictions, e.g: fasting prior to site visits and scans, no physically strenous exercise for 48 hours prior to a visit.
What are the benefits for study participants?
- There may be no direct benefit to a study participant.
- They will receive care from a study doctor with experience in looking after patients with T2DM and NAFLD.
- Their T2DM and NAFLD will be regularly monitored throughout the study.