This study will evaluate the effect of efinopegdutide administration once every 2 weeks (Q2W) versus once weekly (Q1W) on mean relative reduction from baseline in liver fat content (LFC) after 28 weeks, as well as the safety and tolerability of the different regimens of efinopegdutide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
SC injections in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg in all arms and 15 mg in the Efinopegdutide Q2W 15 mg arm
The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0
Chandler, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0224)
Peoria, Arizona, United States
Arizona Liver Health ( Site 0211)
Tucson, Arizona, United States
Del Sol Research Management, LLC ( Site 0209)
Tucson, Arizona, United States
Om Research LLC ( Site 0207)
Camarillo, California, United States
Mean Relative Reduction From Baseline in Liver Fat Content at Week 28
Liver fat content (LFC) was measured with liver images taken by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) and analyzed by blinded independent central review (BICR). Relative Reduction from Baseline to Week 28 = (Baseline - Week 28) / Baseline x 100%. Least Squares (LS) Mean relative reduction from baseline in LFC is presented.
Time frame: Baseline and Week 28
Percentage of Participants Who Experienced an Adverse Event (AE)
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who experienced an AE is presented.
Time frame: Up to Week 32
Percentage of Participants Who Discontinued Study Intervention Due to an AE
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who discontinued study intervention due to an AE is presented.
Time frame: Up to Week 28
Mean Percent Change From Baseline in Body Weight at Week 28
Body weight in kilograms was measured using a standardized, digital scale. Mean percent change in body weight from Baseline to Week 28 = (Week 28 - Baseline) / Baseline x 100%. The LS mean percent change from baseline in body weight at 28 weeks is presented.
Time frame: Baseline and Week 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Gastroenterology and Liver Institute ( Site 0263)
Escondido, California, United States
Velocity Clinical Research, Gardena ( Site 0235)
Gardena, California, United States
Velocity Clinical Research, Huntington Park ( Site 0210)
Huntington Park, California, United States
California Liver Research Institute ( Site 0216)
Pasadena, California, United States
Acclaim Clinical Research ( Site 0241)
San Diego, California, United States
...and 29 more locations