Obese, Obesity, Obesity Type 2 Diabetes Mellitus, Weight Loss
Conditions
Keywords
Obese, obesity, Obesity Type 2 Diabetes, Weight Loss
Brief summary
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).
Interventions
DRUGAleniglipron
Drug aleniglipron administered orally
DRUGPlacebo
Drug placebo administered orally
Sponsors
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence, severity and relationship of AEs/SAEs | Baseline to week 31 | — |
| Assessment of vital signs | Baseline to week 31 | Number of Participants with Clinically Significant Change from Baseline in Vital Signs: including Systolic and Diastolic Blood Pressure, Heart Rate, and temperature. |
| Assessment of laboratory measures | Baseline to week 31 | Number of Participants with Clinically Significant Change from Baseline in Laboratory Parameters: including hematology, serum chemistry, coagulation |
| Assessment of Electrocardiograms (ECG) | Baseline to week 31 | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change in body weight from Baseline | Baseline to week 31 |
| Percent change in body weight from Baseline | Baseline to week 31 |
| Change in HbA1c from Baseline | Baseline to week 30 |
| Change in fasting plasma glucose from Baseline | Baseline to week 31 |
| PK parameters including but not limited to AUC | Baseline to week 30 |
| PK parameters including but not limited to Cmax | Baseline to week 30 |
| PK parameters including but not limited to Tmax | Baseline to week 30 |
| PK parameters including but not limited to Ctrough | Baseline to week 30 |
Countries
United States
Outcome results
None listed