Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (GSBR-1290) dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 44-week period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
82
Drug: aleniglipron administered orally; Drug: placebo administered orally
Drug: aleniglipron administered orally; Drug: placebo administered orally
Drug: aleniglipron administered orally; Drug: placebo administered orally
Drug: aleniglipron administered orally; Drug: placebo administered orally
ACCESS II Research Site
Glendale, California, United States
ACCESS II Research Site
Montclair, California, United States
ACCESS II Research Site
Valparaiso, Indiana, United States
ACCESS II Research Site
West Des Moines, Iowa, United States
ACCESS II Research Site
Medford, Oregon, United States
ACCESS II Research Site
East Greenwich, Rhode Island, United States
ACCESS II Research Site
North Charleston, South Carolina, United States
ACCESS II Research Site
Dallas, Texas, United States
ACCESS II Research Site
San Antonio, Texas, United States
ACCESS II Research Site
West Jordan, Utah, United States
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Baseline and week 44
Adverse events of special interest
Time frame: Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters, including hematology, plasma chemistry, coagulation, and urinalysis
Time frame: Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to : heart rate and QRS duration
Time frame: Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, including systolic and diastolic Blood Pressure, Heart Rate, Respiratory Rate, and temperature
Time frame: Baseline and week 44
Area Under the Plasma Concentration-time Curve From Time 0 to Tau (AUC0-tau)
Time frame: Baseline and week 44
Maximum Observed Plasma Concentration (Cmax) of aleniglipron
Time frame: Baseline and week 44
Trough Concentrations (Ctrough) of aleniglipron
Time frame: Baseline and week 44
Time of Maximum Observed Plasma Concentration (Tmax) of aleniglipron
Time frame: Baseline and week 44
Terminal Elimination Half-life (t1/2) for aleniglipron
Time frame: Baseline and week 44
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