This study will test olatorepatide (study drug) to determine how safe and effective this drug is and how easily your body can accept this drug without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity. The study will test how safe and effective the study drug works compared to placebo in people who are overweight or obese but do not have diabetes. The study is looking at: * What side effects the study drug might cause * How much the study drug is in the blood at different times * How well the study drug works * If the body makes antibodies to the study drug as this may cause the study drug to not work as well
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Administered per the protocol
Administered per the protocol
Diablo Clinical Research - Flourish Research
Walnut Creek, California, United States
RECRUITINGClinical Site Partners, LLC DBA Flourish Research
Winter Park, Florida, United States
RECRUITINGFlourish Research - San Antonio Medical Trials
San Antonio, Texas, United States
RECRUITINGOccurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 30 weeks
Severity of TEAEs
Time frame: Up to approximately 30 weeks
Maximum plasma Concentration (Cmax)
Time frame: At week 15 and week 24
Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h)
Time frame: At week 15 and week 24
Percent change in body weight
Time frame: From baseline to week 25
Change in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP)
Time frame: From baseline to weeks 7, 15 and 24
Change in in-clinic SBP
Time frame: From baseline to weeks 7, 15 and 24
Lowest concentration in a dosing interval (Ctrough)
Time frame: Up to approximately 30 weeks
Time to Cmax (Tmax)
Time frame: Up to approximately 30 weeks
Apparent Volume of distribution (Vd/F)
Time frame: Up to approximately 30 weeks
Apparent clearance (CL/F)
Time frame: Up to approximately 30 weeks
Apparent terminal half-life (t½)
Time frame: Up to approximately 30 weeks
Olatorepatide concentrations
Time frame: Up to approximately 30 weeks
Occurrence of Anti-Drug Antibody (ADA) to olatorepatide
Time frame: Up to approximately 30 weeks
Magnitude of ADA to olatorepatide
Time frame: Up to approximately 30 weeks
Corrected QT interval using the Fridericia formula (QTcF)
Time frame: Pre-dose to up to 48 hours post-dose
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