A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus
Summary
This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy. Participants will be treated for 16 weeks with placebo or 1 of 2 doses of investigational product to determine the effect on liver fat, HbA1c, safety, tolerability and pharmacodynamics.
Timeline
- Start
- 2019-07-18
- Primary completion
- 2021-03-02
- Completion
- 2021-03-30
Outcome
Mixed primary results
registry analysis (equivalence test); Placebo vs PF-06835919 300 mg; p = 0.0288; Mean Difference (Final Values) -14.64 (90% CI -24.18 to -3.89); ANCOVA NCT03969719 ↗
registry analysis (equivalence test); Placebo vs PF-06835919 150 mg; p = 0.0696; Mean Difference (Final Values) -12.44 (90% CI -22.37 to -1.25); ANCOVA NCT03969719 ↗
registry analysis (equivalence test); Placebo vs PF-06835919 150 mg; p = 0.6336; Mean Difference (Final Values) -0.08 (90% CI -0.36 to 0.20); Mixed Models Analysis NCT03969719 ↗
registry analysis (equivalence test); Placebo vs PF-06835919 300 mg; p = 0.1266; Mean Difference (Final Values) -0.25 (90% CI -0.52 to 0.02); Mixed Models Analysis NCT03969719 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PF-06835919 | Small molecule | 150 mg | — |
| Subject | PF-06835919 | Small molecule | 300 mg | — |