Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)
Public ClinicalTrials.gov record NCT07654361. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Pivotal Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of Multiple Maintenance Doses of Once Daily Oral Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and a Weight-Related Comorbidity
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.
Study identification
- NCT ID
- NCT07654361
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,600 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 79 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 12, 2026
- Primary completion
- Aug 31, 2028
- Completion
- Oct 31, 2028
- Last update posted
- Aug 9, 2026
2026 – 2028
United States locations
- U.S. sites
- 71
- U.S. states
- 32
- U.S. cities
- 67
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ACCOMPLISH-1 Research Site | Birmingham | Alabama | 35242 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Birmingham | Alabama | 35294-3360 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Phoenix | Arizona | 85225 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Sun City West | Arizona | 85375 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Tucson | Arizona | 85741 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Escondido | California | 92025 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Gardena | California | 92708 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | La Jolla | California | 92108 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Modesto | California | 95355 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Rolling Hills Estates | California | 90274 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | San Diego | California | 92123 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Clearwater | Florida | 33756 | Recruiting |
| ACCOMPLISH-1 Research Site | Leesburg | Florida | 34748 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Miami | Florida | 33136 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Ocala | Florida | 34470 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Ocoee | Florida | 34761 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Pembroke | Florida | 33027 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Tampa | Florida | 33617 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Buford | Georgia | 30046 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Columbus | Georgia | 31904 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Lawrenceville | Georgia | 30046 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Union City | Georgia | 30291 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Woodstock | Georgia | 30189 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Honolulu | Hawaii | 96814-4526 | Recruiting |
| ACCOMPLISH-1 Research Site | Meridian | Idaho | 83646 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Rexburg | Idaho | 83440 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Chicago | Illinois | 60637 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Iowa City | Iowa | 52242 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Wichita | Kansas | 67218 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Louisville | Kentucky | 40213 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Baton Rouge | Louisiana | 70808 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Silver Spring | Maryland | 20901-4402 | Recruiting |
| ACCOMPLISH-1 Research Site | Methuen | Massachusetts | 01844 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Needham | Massachusetts | 02492 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Ann Arbor | Michigan | 48105-1912 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Mankato | Minnesota | 56001 | Recruiting |
| ACCOMPLISH-1 Research Site | Richfield | Minnesota | 55423 | Recruiting |
| ACCOMPLISH-1 Research Site | Gulfport | Mississippi | 39503 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Ridgeland | Mississippi | 39157 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Chesterfield | Missouri | 63005 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Hazelwood | Missouri | 63042 | Recruiting |
| ACCOMPLISH-1 Research Site | St Louis | Missouri | 63303-3041 | Recruiting |
| ACCOMPLISH-1 Research Site | Butte | Montana | 59701 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Missoula | Montana | 59804 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Omaha | Nebraska | 68198-7400 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Las Vegas | Nevada | 89128 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Albany | New York | 12208-3473 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Brooklyn | New York | 11220 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Charlotte | North Carolina | 28210 | Recruiting |
| ACCOMPLISH-1 Research Site | Durham | North Carolina | 27710-3000 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Fayetteville | North Carolina | 28304 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | New Bern | North Carolina | 28562 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Wilmington | North Carolina | 28401 | Recruiting |
| ACCOMPLISH-1 Research Site | Winston-Salem | North Carolina | 27104 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Columbus | Ohio | 43213 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Columbus | Ohio | 43215 | Recruiting |
| ACCOMPLISH-1 Research Site | Moore | Oklahoma | 73160 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Portland | Oregon | 97202 | Recruiting |
| ACCOMPLISH-1 Research Site | Philadelphia | Pennsylvania | 19152 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Greer | South Carolina | 29651 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Knoxville | Tennessee | 37920 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Austin | Texas | 78704 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Austin | Texas | 78731 | Recruiting |
| ACCOMPLISH-1 Research Site | Denison | Texas | 75020-4582 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Houston | Texas | 77040 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Houston | Texas | 77054 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | San Antonio | Texas | 78231 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Wylie | Texas | 75098 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Sandy City | Utah | 84094 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | St. George | Utah | 84790 | Not yet recruiting |
| ACCOMPLISH-1 Research Site | Renton | Washington | 98057 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07654361, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07654361 live on ClinicalTrials.gov.