This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses of aleniglipron in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to aleniglipron or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment. At the end of the study (after completing 36 weeks of treatment), participants will be offered to continue with an open-label extension (OLE) where they will receive aleniglipron for an additional 36 weeks.
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Percent change in body weight from Baseline to Week 36
Timeframe: Baseline and week 36
TEAEs and SAEs
Timeframe: Baseline and week 72
AESI
Timeframe: Baseline and week 72
Evaluate the safety and tolerability of participants with abnormal laboratory values, including hematology, serum chemistry, and coagulation
Timeframe: Baseline and week 72
Evaluate long-term safety and tolerability of aleniglipron as measured through electrocardiograms (including, but not limited to, the measurements of ventricular HR, PR interval, QRS duration, QT interval, and QTcF)
Timeframe: Baseline and week 72
Evaluate the safety and tolerability of participants with abnormal vital signs, including blood pressure, heart rate, and temperature
Timeframe: Baseline and week 72