Chronic Weight Management, Obesity, Overweight
Conditions
Keywords
Obesity, Overweight, GSBR-1290, Aleniglipron, Chronic weight management, Obese, Small molecule, GLP-1, Structure Therapeutics
Brief summary
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.
Interventions
DRUGAleniglipron
Drug: aleniglipron administered orally Drug
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 * BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.
Exclusion criteria
* Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes. * Self-reported change in body weight \>5 kg within 3 months before Screening. * Have prior or planned surgical or non-surgical treatment for obesity. * Have or plan to have endoscopic and/or device-based therapy for obesity. * Have obesity induced by other endocrine disorders. * Impaired renal function at Screening * Chronic malabsorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in body weight from Baseline | Baseline and Week 76 |
Secondary
| Measure | Time frame |
|---|---|
| Change in body weight (absolute) from Baseline | Baseline and week 76 |
| Percentage of participants who achieve ≥5% reduction in body weight | Baseline and week 76 |
| Percentage of participants who achieve ≥10% reduction in body weight | Baseline and week 76 |
| Percentage of participants who achieve ≥15% reduction in body weight | Baseline and week 76 |
| Percentage of participants who achieve ≥20% reduction in body weight | Baseline and week 76 |
| Change in waist circumference from Baseline | Baseline and week 76 |
| Change in resting systolic blood pressure from Baseline | Baseline and week 76 |
| Percent change in fasting triglycerides and non-HDL cholesterol from Baseline | Baseline and week 76 |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version physical function from Baseline | Baseline and week 76 |
| Change in HbA1c from Baseline | Baseline and week 76 |
| Change in body mass index from Baseline | Baseline and week 76 |
| Percent change in fasting total cholesterol from Baseline | Baseline and week 76 |
| Change in fasting glucose from Baseline | Baseline and week 76 |
| Change in resting diastolic blood pressure from Baseline | Baseline and week 76 |
Countries
United States
Contacts
CONTACTMedical Director
Outcome results
None listed