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ClinicalTrials.gov record
Recruiting Phase 3 Interventional

Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)

ClinicalTrials.gov ID: NCT07654361

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.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 6:22 PM EDT

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

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.

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