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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
164
Percent Change From Baseline in Whole Liver Fat at Week 16
Whole liver fat was measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF).
Time frame: Baseline, Week 16.
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16
A sufficient amount of blood was collected for the analysis of plasma HbA1c.
Time frame: Baseline, Week 16.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or that was considered to be an important medical event. An AE was considered TEAE if the event occurred during the on-treatment period. The causality of AEs were assessed by the investigator using clinical judgement. A severe AE was an event that prevents normal everyday activities.
Time frame: Up to 21 weeks.
Number of Participants With Hypoglycemia TEAEs
Hypoglycemic AEs were routinely monitored during participation in the study. Hypoglycemic AE was defined as 1 of the following: 1. Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemic AE but a plasma glucose value of \<70 milligram per deciliter (mg/dL) using glucometer; 2. Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemic AEs were accompanied with a glucose value of \<70 mg/dL using glucometer and the clinical picture included prompt resolution with food intake, subcutaneous glucagon or intravenous (IV) glucose; 3. Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemic AEs were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose concentration of \<70 mg/dL, and the clinical picture included prompt resolution with food intake, subcutaneous glucagon, or IV glucose.
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Horizon Clinical Research Associates, PLLC
Gilbert, Arizona, United States
Clinical Research Consortium an AMR company
Tempe, Arizona, United States
Anaheim Clinical Trials LLC-Clinical Research
Anaheim, California, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Hope Clinical Research
Canoga Park, California, United States
San Diego Imaging SDI
Chula Vista, California, United States
Sharp Coronado Hospital
Coronado, California, United States
Southern California Research Center
Coronado, California, United States
Holy Trinity Medical Clinic
Harbor City, California, United States
Innovative Clinical Research, Inc.
Harbor City, California, United States
...and 96 more locations
Time frame: Up to 21 weeks.
Cumulative Number of Participants With Clinical Laboratory Abnormalities
Clinical laboratory tests included hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean cell hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein); urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy). The abnormality criteria were standard sponsor reporting criteria.
Time frame: Up to 21 weeks.
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria
Vital signs data meeting the following criteria were reported: sitting diastolic blood pressure (DBP) \<50 mmHg or \>= 20 mmHg increase or \>= 20 mmHg decrease, sitting systolic blood pressure (SBP) blood pressure \<90 mmHg or \>=30 mmHg increase or \>=30 mmHg decrease.
Time frame: Up to 21 weeks.
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria
ECG data meeting the following criteria were reported: PR interval value \>=300 msec, QRS interval percent change \>= 50%, QTcF interval value \>450 msec and \<=480 msec, or change \>30 msec and \<=60 msec, or change \>60 msec.
Time frame: Up to 21 weeks.
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over 16 Weeks
Blood samples were collected to ensure sufficient serum for the analysis of hs-CRP.
Time frame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Change From Baseline in Fasting Insulin Over 16 Weeks
A sufficient amount of blood was collected for the analysis of plasma insulin. The unit of insulin is milli-international units per liter (mIU/L).
Time frame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Change From Baseline in Fasting Glucose Over 16 Weeks
A sufficient amount of blood was collected for the analysis of plasma glucose.
Time frame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Change From Baseline in Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Over 16 Weeks
HOMA-IR values were derived from fasting plasma insulin and glucose values. Greater reduction from baseline in HOMA-IR scale values shows greater effects on glycemic metabolism.
Time frame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Percent Change From Baseline in Alanine Aminotransferase (ALT) Over 16 Weeks
ALT was assessed as one of the clinical laboratory chemistry tests.
Time frame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Change From Baseline in HbA1c at All Timepoints Other Than Week 16
A sufficient amount of blood was collected for the analysis of plasma HbA1c.
Time frame: From Baseline to Week 2, Week, 4, Week 8, and Week 12.