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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aleniglipron Arm 1 | Experimental | Participants will receive aleniglipron administered orally. |
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| aleniglipron Arm 2 | Experimental | Participants will receive aleniglipron administered orally. |
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| aleniglipron Arm 3 | Experimental | Participants will receive aleniglipron administered orally. |
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| Placebo Arm 4 | Placebo Comparator | Participants will receive placebo administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aleniglipron | Drug | Drug: aleniglipron administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent change in body weight from Baseline | Baseline and week 76 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Contact | 1-650-457-1959 | GSBRClinicalTrials@structuretx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACCOMPLISH-2 Research Site | Birmingham | Alabama | 35242 | United States |
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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| aleniglipron |
| Drug |
Drug: aleniglipron administered orally |
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| aleniglipron | Drug | Drug: aleniglipron administered orally |
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| Placebo | Drug | Drug: placebo administered orally |
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| 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 |
| ACCOMPLISH-2 Research Site | Chandler | Arizona | 85225 | United States |
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| ACCOMPLISH-2 Research Site | Phoenix | Arizona | 85028 | United States |
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| ACCOMPLISH-2 Research Site | Sun City West | Arizona | 85375 | United States |
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| ACCOMPLISH-2 Research Site | Tucson | Arizona | 85741 | United States |
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| ACCOMPLISH-2 Research Site | Little Rock | Arkansas | 72211 | United States |
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| ACCOMPLISH-2 Research Site | Escondido | California | 92025 | United States |
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| ACCOMPLISH-2 Research Site | Fountain Valley | California | 92708 | United States |
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| ACCOMPLISH-2 Research Site | Lake Forest | California | 92630 | United States |
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| ACCOMPLISH-2 Research Site | Rolling Hills Estates | California | 90274 | United States |
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| ACCOMPLISH-2 Research Site | San Diego | California | 92108 | United States |
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| ACCOMPLISH-2 Research Site | San Diego | California | 92123 | United States |
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| ACCOMPLISH-2 Research Site | Tustin | California | 92780 | United States |
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| ACCOMPLISH-2 Research Site | Waterbury | Connecticut | 06708 | United States |
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| ACCOMPLISH-2 Research Site | Clearwater | Florida | 33756 | United States |
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| ACCOMPLISH-2 Research Site | Fort Myers | Florida | 33912 | United States |
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| ACCOMPLISH-2 Research Site | Jacksonville | Florida | 32216 | United States |
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| ACCOMPLISH-2 Research Site | Leesburg | Florida | 34748 | United States |
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| ACCOMPLISH-2 Research Site | Miami | Florida | 33136 | United States |
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| ACCOMPLISH-2 Research Site | Ocala | Florida | 34470 | United States |
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| ACCOMPLISH-2 Research Site | Ocoee | Florida | 34761 | United States |
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| ACCOMPLISH-2 Research Site | Pembroke Pines | Florida | 33027 | United States |
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| ACCOMPLISH-2 Research Site | Atlanta | Georgia | 30329 | United States |
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| ACCOMPLISH-2 Research Site | Columbus | Georgia | 31904 | United States |
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| ACCOMPLISH-2 Research Site | Lawrenceville | Georgia | 30046 | United States |
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| ACCOMPLISH-2 Research Site | Union City | Georgia | 30291 | United States |
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| ACCOMPLISH-2 Research Site | Woodstock | Georgia | 30189 | United States |
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| ACCOMPLISH-2 Research Site | Meridian | Idaho | 83646 | United States |
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| ACCOMPLISH-2 Research Site | Des Moines | Iowa | 50314 | United States |
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| ACCOMPLISH-2 Research Site | Iowa City | Iowa | 52242 | United States |
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| ACCOMPLISH-2 Research Site | Wichita | Kansas | 67218 | United States |
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| ACCOMPLISH-2 Research Site | Silver Spring | Maryland | 20901 | United States |
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| ACCOMPLISH-2 Research Site | Methuen | Massachusetts | 01844 | United States |
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| ACCOMPLISH-2 Research Site | Mankato | Minnesota | 56001 | United States |
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| ACCOMPLISH-2 Research Site | Minneapolis | Minnesota | 55423 | United States |
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| ACCOMPLISH-2 Research Site | Gulfport | Mississippi | 39503 | United States |
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| ACCOMPLISH-2 Research Site | Ridgeland | Mississippi | 39157 | United States |
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| ACCOMPLISH-2 Research Site | Chesterfield | Missouri | 63005 | United States |
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| ACCOMPLISH-2 Research Site | City of Saint Peters | Missouri | 63303 | United States |
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| ACCOMPLISH-2 Research Site | Hazelwood | Missouri | 63042 | United States |
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| ACCOMPLISH-2 Research Site | Springfield | Missouri | 65807 | United States |
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| ACCOMPLISH-2 Research Site | St Louis | Missouri | 63141 | United States |
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| ACCOMPLISH-2 Research Site | Missoula | Montana | 59804 | United States |
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| ACCOMPLISH-2 Research Site | Omaha | Nebraska | 68105 | United States |
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| ACCOMPLISH-2 Research Site | Las Vegas | Nevada | 89128 | United States |
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| ACCOMPLISH-2 Research Site | Albany | New York | 12206 | United States |
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| ACCOMPLISH-2 Research Site | Albany | New York | 12208 | United States |
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| ACCOMPLISH-2 Research Site | Brooklyn | New York | 11220 | United States |
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| ACCOMPLISH-2 Research Site | The Bronx | New York | 10455 | United States |
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| ACCOMPLISH-2 Research Site | Charlotte | North Carolina | 28210 | United States |
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| ACCOMPLISH-2 Research Site | Durham | North Carolina | 27710 | United States |
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| ACCOMPLISH-2 Research Site | Fayetteville | North Carolina | 28304 | United States |
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| ACCOMPLISH-2 Research Site | Morehead City | North Carolina | 23730 | United States |
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| ACCOMPLISH-2 Research Site | Winston-Salem | North Carolina | 27104 | United States |
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| ACCOMPLISH-2 Research Site | Columbus | Ohio | 43213 | United States |
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| ACCOMPLISH-2 Research Site | Moore | Oklahoma | 73160 | United States |
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| ACCOMPLISH-2 Research Site | Tulsa | Oklahoma | 74133 | United States |
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| ACCOMPLISH-2 Research Site | Yukon | Oklahoma | 73099 | United States |
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| ACCOMPLISH-2 Research Site | Portland | Oregon | 97202 | United States |
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| ACCOMPLISH-2 Research Site | Philadelphia | Pennsylvania | 19152 | United States |
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| ACCOMPLISH-2 Research Site | Greer | South Carolina | 29651 | United States |
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| ACCOMPLISH-2 Research Site | Nashville | Tennessee | 37203 | United States |
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| ACCOMPLISH-2 Research Site | Austin | Texas | 78704 | United States |
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| ACCOMPLISH-2 Research Site | Farmers Branch | Texas | 75234 | United States |
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| ACCOMPLISH-2 Research Site | Houston | Texas | 77040 | United States |
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| ACCOMPLISH-2 Research Site | Houston | Texas | 77054 | United States |
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| ACCOMPLISH-2 Research Site | San Antonio | Texas | 78229 | United States |
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| ACCOMPLISH-2 Research Site | San Antonio | Texas | 78230 | United States |
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| ACCOMPLISH-2 Research Site | Wylie | Texas | 75098 | United States |
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| ACCOMPLISH-2 Research Site | Salt Lake City | Utah | 84107 | United States |
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| ACCOMPLISH-2 Research Site | Burke | Virginia | 22015 | United States |
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| ACCOMPLISH-2 Research Site | Manassas | Virginia | 20110 | United States |
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| ACCOMPLISH-2 Research Site | Suffolk | Virginia | 23435 | United States |
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| ACCOMPLISH-2 Research Site | Renton | Washington | 98057 | United States |
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| 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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