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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive aleniglipron or placebo administered orally. |
|
| Cohort 2 | 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 |
|---|---|---|
| Percent change in total body fat mass by DXA | Baseline and week 44 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient-reported outcome SF-36 acute version | Baseline and week 44 | |
| Change in patient-reported outcome IWQOL-Lite CT | Baseline and week 44 | |
| Change in patient-reported outcome hunger/satiety evaluation checklist |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85020 | United States | ||
| 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). Gasherbrum Bio, Inc. does not grant external requests for individual de-identified patient data for the following purposes:
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| Baseline and week 44 |
| Percent change in waist circumference | Baseline and week 44 |
| Baseline and week 44 |
| Change in high-density lipoprotein and low-density lipoprotein cholesterol | Baseline and week 44 |
| Chicago |
| Illinois |
| 60602 |
| United States |
| Research Site | Richfield | Minnesota | 55423 | United States |
| Research Site | City of Saint Peters | Missouri | 63303 | United States |
| Research Site | Rochester | New York | 14609 | United States |
| Research Site | Wilmington | North Carolina | 28401 | United States |
| Research Site | Norman | Oklahoma | 73069 | United States |
| Research Site | Moncks Corner | South Carolina | 29461 | United States |
| Research Site | North Charleston | South Carolina | 29405 | United States |
| Research Site | Austin | Texas | 78704 | United States |
| Research Site | San Antonio | Texas | 78240 | 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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