The purpose of this study is to assess the safety and tolerability of aleniglipron at doses up to 240 mg once daily (QD) in participants with T2DM who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
58
Drug aleniglipron administered orally
Drug placebo administered orally
Research Site
Anniston, Alabama, United States
Research Site
Lake Forest, California, United States
Research Site
Lomita, California, United States
Incidence, severity and relationship of AEs/SAEs
Time frame: Baseline to week 31
Assessment of vital signs
Number of Participants with Clinically Significant Change from Baseline in Vital Signs: including Systolic and Diastolic Blood Pressure, Heart Rate, and temperature.
Time frame: Baseline to week 31
Assessment of laboratory measures
Number of Participants with Clinically Significant Change from Baseline in Laboratory Parameters: including hematology, serum chemistry, coagulation
Time frame: Baseline to week 31
Assessment of Electrocardiograms (ECG)
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: ventricular heart rate, PR interval, QRS duration, QT interval, and QTcF
Time frame: Baseline to week 31
Absolute change in body weight from Baseline
Time frame: Baseline to week 31
Percent change in body weight from Baseline
Time frame: Baseline to week 31
Change in HbA1c from Baseline
Time frame: Baseline to week 30
Change in fasting plasma glucose from Baseline
Time frame: Baseline to week 31
PK parameters including but not limited to AUC
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Research Site
Hazelwood, Missouri, United States
Research Site
Columbus, Ohio, United States
Research Site
Moncks Corner, South Carolina, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
DeSoto, Texas, United States
...and 6 more locations
Time frame: Baseline to week 30
PK parameters including but not limited to Cmax
Time frame: Baseline to week 30
PK parameters including but not limited to Tmax
Time frame: Baseline to week 30
PK parameters including but not limited to Ctrough
Time frame: Baseline to week 30