Chronic Weight Management, Obesity, Overweight, Type2 Diabetes Mellitus
Conditions
Keywords
obesity, overweight, GSBR-1290, aleniglipron, chronic weight management, obese, type 2diabetes mellitus, small molecule, GLP-1, Structure Therapeutics
Brief summary
This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76 weeks of treatment.
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
Yes
Inclusion criteria
* Signed Informed Consent * Have a BMI ≥27.0 kg/m2 at Screening * Have a diagnosis of T2DM according to the WHO classification or other locally applicable standards, with HbA1c ≥6.5% (≥53 mmol/mol) to ≤10% (86 mmol/mol) at Screening
Exclusion criteria
* Have type 1 diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM. * Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 180 days prior to Screening. * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * Self-reported change in body weight \>5 kg (11 pounds) within 3 months before Screening. * Have prior or planned surgical or non-surgical treatment for obesity.
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 |
| Change in waist circumference from Baseline | Baseline and week 76 |
| Change in HbA1c 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 |
| Percentage of participants achieving HbA1c target value of ≤6.5% | Baseline and week 76 |
Countries
United States
Contacts
CONTACTMedical Director
Outcome results
None listed