Active, not recruitingPhase 2Interventional
What this study is about
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).
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 79 Years
SexAll
Healthy volunteersNot accepted
ConditionObese, Obesity, Obesity Type 2 Diabetes Mellitus, Weight Loss
Full registry criteria
Inclusion Criteria: * Signed Informed Consent * A diagnosis of T2DM of ≥6 months, * Hemoglobin A1c (HbA1c) ≥6.5% to ≤10% at Screening * Have a BMI ≥27.0 kg/m2 Exclusion Criteria: * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. All participants must have a photo fundoscopy, optical coherence tomography, or slit lamp assessment prior to randomization and within the last 12 months to confirm the absence or stable status of diabetic retinopathy and/or macular edema. * Present or planned use of any drug that could interfere with glucose levels * Self-reported change in body weight \>5 kg (11 pounds) within 3 months before screening * Have prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \>1 year prior to Screening) * Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to Screening, including, but not limited to, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal endoluminal liner
Primary outcomes
Incidence, severity and relationship of AEs/SAEsBaseline to week 31
Assessment of vital signsBaseline to week 31Number of Participants with Clinically Significant Change from Baseline in Vital Signs: including Systolic and Diastolic Blood Pressure, Heart Rate, and temperature.
Assessment of laboratory measuresBaseline to week 31Number of Participants with Clinically Significant Change from Baseline in Laboratory Parameters: including hematology, serum chemistry, coagulation
Assessment of Electrocardiograms (ECG)Baseline to week 31Number 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
