Obesity, Overweight, or Chronic Weight Management
Conditions
Keywords
ACCESS, obesity, overweight, GSBR-1290, aleniglipron, chronic weight management, obese, small molecule, GLP-1 receptor agonist, Structure Therapeutics
Brief summary
This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses of aleniglipron in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to aleniglipron or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment. At the end of the study (after completing 36 weeks of treatment), participants will be offered to continue with an open-label extension (OLE) where they will receive aleniglipron for an additional 36 weeks.
Interventions
Drug: Aleniglipron Administered orally Drug: Placebo Administered orally
DRUGAleniglipron
Drug: Aleniglipron 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 or BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesity related comorbidity
Exclusion criteria
* Previous documented diagnosis of diabetes mellitus. * Self-reported change in body weight \>5% within 3 months before Screening * Body weight ≤80 kg at Screening * Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \>1 year prior to screening)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in body weight from Baseline to Week 36 | Baseline and week 36 | Double Blind Period |
| TEAEs and SAEs | Baseline and week 72 | Open -Label Extension |
| AESI | Baseline and week 72 | Open -Label Extension |
| Evaluate the safety and tolerability of participants with abnormal laboratory values, including hematology, serum chemistry, and coagulation | Baseline and week 72 | Open -Label Extension |
| Evaluate long-term safety and tolerability of aleniglipron as measured through electrocardiograms (including, but not limited to, the measurements of ventricular HR, PR interval, QRS duration, QT interval, and QTcF) | Baseline and week 72 | Open -Label Extension |
| Evaluate the safety and tolerability of participants with abnormal vital signs, including blood pressure, heart rate, and temperature | Baseline and week 72 | Open -Label Extension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who achieve ≥5% reduction in body weight at Week 36 | Baseline and week 36 | Double Blind Period |
| Percentage of participants who achieve ≥10% reduction in body weight at Week 36 | Baseline and week 36 | Double Blind Period |
| Percentage of participants who achieve ≥15% reduction in body weight at Week 36 | Baseline and week 36 | Double Blind Period |
| Change in body weight (absolute) from Baseline to Week 36 | Baseline and week 36 | Double Blind Period |
| Change in waist circumference from Baseline to Week 36 | Baseline and week 36 | Double Blind Period |
| Change in body mass index from Baseline to Week 36 | Baseline and week 36 | Double Blind Period |
| Percent change in body weight | Baseline to week 72 & Week 36-72 | Open -Label Extension |
| Percentage of participants who achieve ≥5% reduction in body weight | Baseline to week 72 & Week 36-72 | Open -Label Extension |
| Percentage of participants who achieve ≥10% reduction in body weight | Baseline to week 72 & Week 36-72 | Open -Label Extension |
| Percentage of participants who achieve ≥15% reduction in body weight | Baseline to week 72 & Week 36-72 | Open -Label Extension |
| Change in body weight | Baseline to week 72 & Week 36-72 | Open -Label Extension |
| Change in body mass | Baseline to week 72 & Week 36-72 | Open -Label Extension |
| Change in waist circumference | Baseline to week 72 & Week 36-72 | Open -Label Extension |
Countries
United States
Outcome results
None listed