Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
3,600
Drug: aleniglipron administered orally Drug
Drug: placebo administered orally
ACCOMPLISH-1 Research Site
Birmingham, Alabama, United States
NOT_YET_RECRUITINGACCOMPLISH-1 Research Site
Birmingham, Alabama, United States
NOT_YET_RECRUITINGACCOMPLISH-1 Research Site
Phoenix, Arizona, United States
NOT_YET_RECRUITINGACCOMPLISH-1 Research Site
Sun City West, Arizona, United States
NOT_YET_RECRUITINGPercent change in body weight from Baseline
Time frame: Baseline and Week 76
Change in body weight (absolute) from Baseline
Time frame: Baseline and week 76
Percentage of participants who achieve ≥5% reduction in body weight
Time frame: Baseline and week 76
Percentage of participants who achieve ≥10% reduction in body weight
Time frame: Baseline and week 76
Percentage of participants who achieve ≥15% reduction in body weight
Time frame: Baseline and week 76
Percentage of participants who achieve ≥20% reduction in body weight
Time frame: Baseline and week 76
Change in waist circumference from Baseline
Time frame: Baseline and week 76
Change in resting systolic blood pressure from Baseline
Time frame: Baseline and week 76
Percent change in fasting triglycerides and non-HDL cholesterol from Baseline
Time frame: Baseline and week 76
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version physical function from Baseline
Time frame: Baseline and week 76
Change in HbA1c from Baseline
Time frame: Baseline and week 76
Change in body mass index from Baseline
Time frame: Baseline and week 76
Percent change in fasting total cholesterol from Baseline
Time frame: Baseline and week 76
Change in fasting glucose from Baseline
Time frame: Baseline and week 76
Change in resting diastolic blood pressure from Baseline
Time frame: Baseline and week 76
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ACCOMPLISH-1 Research Site
Tucson, Arizona, United States
NOT_YET_RECRUITINGACCOMPLISH-1 Research Site
Escondido, California, United States
NOT_YET_RECRUITINGACCOMPLISH-1 Research Site
Gardena, California, United States
NOT_YET_RECRUITINGACCOMPLISH-1 Research Site
La Jolla, California, United States
NOT_YET_RECRUITINGACCOMPLISH-1 Research Site
Modesto, California, United States
NOT_YET_RECRUITINGACCOMPLISH-1 Research Site
Rolling Hills Estates, California, United States
NOT_YET_RECRUITING...and 61 more locations