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Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (GSBR-1290) dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 44-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel | Experimental | Participants will receive aleniglipron or placebo administered orally. |
|
| Cohort 1a | Experimental | Participants will receive aleniglipron or placebo administered orally. |
|
| Cohort 1b | Experimental | Participants will receive aleniglipron or placebo administered orally. |
|
| Cohort 1c | Experimental | Participants will receive aleniglipron or placebo administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aleniglipron or placebo | Drug | Drug: aleniglipron administered orally; Drug: placebo administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | Baseline and week 44 | |
| Adverse events of special interest | Baseline and week 44 | |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters, including hematology, plasma chemistry, coagulation, and urinalysis | Baseline and week 44 | |
| 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 : heart rate and QRS duration | Baseline and week 44 | |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs, including systolic and diastolic Blood Pressure, Heart Rate, Respiratory Rate, and temperature | Baseline and week 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From Time 0 to Tau (AUC0-tau) | Baseline and week 44 | |
| Maximum Observed Plasma Concentration (Cmax) of aleniglipron | Baseline and week 44 | |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in body weight | Baseline and week 44 | |
| Change in body weight (absolute) | Baseline and week 44 | |
| Percentage of participants who achieve ≥5% reduction in body weight at Week 44 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACCESS II Research Site | Glendale | California | 91206 | United States | ||
| ACCESS II Research Site |
De-identified individual patient data for variables necessary to address a specific research question in an approved data sharing request
Data sharing requests will be considered beginning 36 months after the study publication (manuscript accepted for publication) and either 1) the product has been granted marketing authorization in at least two regulatory jurisdictions, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Researchers will submit a request containing the research objectives, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Structure Therapeutics does not grant external requests for individual de-identified patient data for the following purposes:
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| aleniglipron or placebo | Drug | Drug: aleniglipron administered orally; Drug: placebo administered orally |
|
| aleniglipron or placebo | Drug | Drug: aleniglipron administered orally; Drug: placebo administered orally |
|
| aleniglipron or placebo | Drug | Drug: aleniglipron administered orally; Drug: placebo administered orally |
|
| Trough Concentrations (Ctrough) of aleniglipron |
| Baseline and week 44 |
| Time of Maximum Observed Plasma Concentration (Tmax) of aleniglipron | Baseline and week 44 |
| Terminal Elimination Half-life (t1/2) for aleniglipron | Baseline and week 44 |
| Baseline and week 44 |
| Percentage of participants who achieve ≥10% reduction in body weight at Week 44 | Baseline and week 44 |
| Percentage of participants who achieve ≥15% reduction in body weight at Week 44 | Baseline and week 44 |
| Change in waist circumference | Baseline and week 44 |
| Change in body mass index | Baseline and week 44 |
| Change in patient-reported outcomes (hunger and satiety questionnaire) | Baseline and week 44 |
| Change in HDL and LDL cholesterol | Baseline and week 44 |
| Montclair |
| California |
| 91763 |
| United States |
| ACCESS II Research Site | Valparaiso | Indiana | 46383 | United States |
| ACCESS II Research Site | West Des Moines | Iowa | 50265 | United States |
| ACCESS II Research Site | Medford | Oregon | 97504 | United States |
| ACCESS II Research Site | East Greenwich | Rhode Island | 02818 | United States |
| ACCESS II Research Site | North Charleston | South Carolina | 29405 | United States |
| ACCESS II Research Site | Dallas | Texas | 75042 | United States |
| ACCESS II Research Site | San Antonio | Texas | 78240 | United States |
| ACCESS II Research Site | West Jordan | Utah | 84088 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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