The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg
Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg
Mean Relative Reduction From Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) After 24 Weeks
LFC was measured with liver images taken by MRI-PDFF and analyzed by BICR. Relative Reduction from Baseline to Week 24 = (Baseline - Week 24) / Baseline x 100%. Mean relative reduction from baseline in liver fat content is presented.
Time frame: Baseline and up to ~24 Weeks
Percentage of Participants Who Experienced an Adverse Event (AE)
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an adverse event is presented.
Time frame: Up to ~29 weeks
Percentage of Participants Who Discontinued Study Intervention Due to an AE
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to adverse event is presented.
Time frame: Up to ~24 weeks
Mean Absolute Reduction From Baseline in LFC Measured by MRI-PDFF (Evaluated by BICR) After 24 Weeks
LFC was measured by liver images taken by MRI-PDFF and analyzed by BICR. The absolute reduction from baseline to Week 24 = Baseline - Week 24. The mean absolute reduction from baseline in LFC after 24 weeks of treatment is presented.
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Catalina Research Institute, LLC ( Site 1939)
Montclair, California, United States
Sweet Hope Research Specialty, Inc ( Site 1902)
Hialeah, Florida, United States
Floridian Clinical Research, LLC ( Site 1950)
Miami Lakes, Florida, United States
Sensible Healthcare, LLC ( Site 1903)
Ocoee, Florida, United States
Lucas Research, Inc ( Site 1930)
Morehead City, North Carolina, United States
Texas Clinical Research Institute ( Site 1910)
Arlington, Texas, United States
Baylor College of Medicine-Advanced Liver Therapies ( Site 1960)
Houston, Texas, United States
American Research Corporation at Texas Liver Institute ( Site 1920)
San Antonio, Texas, United States
Clinical Trials of Texas, Inc. ( Site 1906)
San Antonio, Texas, United States
CIPREC-Laboratorio ( Site 0104)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
...and 59 more locations
Time frame: Baseline and up to ~24 Weeks
Mean Percent Change From Baseline in Body Weight After 24 Weeks
Body weight in kilograms was measured using a standardized, digital scale. The mean percent change from baseline in body weight after 24 weeks is presented.
Time frame: Baseline and up to ~24 weeks
Mean Percent Change From Baseline in Total Cholesterol After 24 Weeks
Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in total cholesterol. The mean percent change in total cholesterol is presented.
Time frame: Baseline and up to ~24 weeks
Mean Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) After 24 Weeks
Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in non-HDL-C. The mean percent change in non-HDL-C is presented.
Time frame: Baseline and up to ~24 weeks
Mean Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks
Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in HDL-C. Mean percent change in HDL-C is presented.
Time frame: Baseline and up to ~24 weeks
Mean Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 Weeks
Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in LDL-C. The mean percent change in LDL-C is presented.
Time frame: Baseline and up to ~24 weeks
Mean Percent Change From Baseline in Triglycerides (TG) After 24 Weeks
Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in triglycerides. The mean percent change in triglycerides is presented.
Time frame: Baseline and up to ~24 weeks
Mean Percent Change From Baseline in Apolipoprotein B (apoB) After 24 Weeks
Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in apoB. The mean percent change in apoB is presented.
Time frame: Baseline and up to ~24 weeks