Phase 2 N=164 Randomized Double-blind Basic Science

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

Non-alcoholic Steatohepatitis

Bottom Line

View on ClinicalTrials.gov: NCT03969719 ↗

Enrolled (actual)

164

Serious AEs

0.6%

Results posted

May 2022

Primary outcome: Primary: Percent Change From Baseline in Whole Liver Fat at Week 16 — -3.21; -16.12; -4.36 Percent change — p=0.0696

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Drug); PF-06835919 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Whole Liver Fat at Week 16	-3.21; -16.12; -4.36	0.0696
PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16	-0.14; -0.24; -0.32	0.6336
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	22; 25; 18; 2; 4; 1	—
SECONDARY Number of Participants With Hypoglycemia TEAEs	1; 1; 0; 0; 0; 0	—
SECONDARY Cumulative Number of Participants With Clinical Laboratory Abnormalities	52; 52; 51	—
SECONDARY Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria	1; 0; 0; 3; 3; 2	—
SECONDARY Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria	0; 1; 0; 0; 0; 1	—
SECONDARY Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over 16 Weeks	40.26; 19.11; 17.50; 50.64; 38.46; -18.25	—
SECONDARY Change From Baseline in Fasting Insulin Over 16 Weeks	1.79; 2.94; 1.53; 2.22; 1.65; -2.47	—
SECONDARY Change From Baseline in Fasting Glucose Over 16 Weeks	7.27; 0.88; -6.35; 5.42; -7.41; -4.47	—
SECONDARY Change From Baseline in Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Over 16 Weeks	1.09; 2.17; 0.36; 1.28; 0.02; -1.04	—
SECONDARY Percent Change From Baseline in Alanine Aminotransferase (ALT) Over 16 Weeks	2.4; -8.8; -6.0; 2.3; -4.1; -5.4	—
SECONDARY Change From Baseline in HbA1c at All Timepoints Other Than Week 16	-0.14; -0.11; -0.07; -0.09; -0.17; -0.21	—

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.

Eligibility Criteria

Inclusion Criteria

Males, or females of nonchildbearing potential
18 to 70 years of age
Type 2 Diabetes Mellitus
Liver fat >/=8% by MRI-PDFF
On stable dose of metformin monotherapy for at least 2 months (at a dose of at least 500 mg daily)

Exclusion Criteria

History of other liver disease
Unable to have an MRI performed
Significant weight loss in the previous month and/or participant in current weight loss program
History of diabetic complications with end-organ damage

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03969719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.