Obesity, Overweight, or Chronic Weight Management
Conditions
Keywords
obesity, overweight, GSBR-1290, aleniglipron, chronic weight management, obese, small molecule, GLP-1 receptor agonist, body composition, Structure Therapeutics
Brief summary
This is a randomized, double-blind, placebo-controlled study evaluating the effects of aleniglipron on body composition in participants living with obesity. Participants will be randomized to aleniglipron or placebo in a ratio of 5:1. Participants will receive multiple ascending QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 40 weeks of treatment.
Interventions
Drug: aleniglipron administered orally 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 * Participants age ≥18 years and \<80 years, with BMI ≥30 kg/m2 * Screening HbA1c \<6.5 %
Exclusion criteria
* Previous documented diagnosis of diabetes mellitus * Self-reported change in body weight \>5% within 3 months before Screening * Have a body weight, height, and/or width that prohibits the ability to obtain accurate measurements according to the DXA study specific manual that allows hemi-scan * Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \>1 year prior to screening) * Have obesity induced by other endocrine disorders (such as Cushing's syndrome, Prader-Willi syndrome, or melanocortin 4 receptor deficiency)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in total body fat mass by DXA | Baseline and week 44 |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in visceral adipose tissue [VAT] by DXA | Baseline and week 44 |
| Percent change in lean body mass by DXA | Baseline and week 44 |
| Percent change in body weight by DXA | Baseline and week 44 |
| Percent change in waist circumference | Baseline and week 44 |
Countries
United States
Outcome results
None listed