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Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)
Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
3600
Start Date
2026-07
Completion Date
2029-04
Last Updated
2026-06-17
Healthy Volunteers
No
Interventions
Aleniglipron
Drug: aleniglipron administered orally Drug
Placebo
Drug: placebo administered orally
Locations (71)
ACCOMPLISH-1 Research Site
Birmingham, Alabama, United States
ACCOMPLISH-1 Research Site
Birmingham, Alabama, United States
ACCOMPLISH-1 Research Site
Phoenix, Arizona, United States
ACCOMPLISH-1 Research Site
Sun City West, Arizona, United States
ACCOMPLISH-1 Research Site
Tucson, Arizona, United States
ACCOMPLISH-1 Research Site
Escondido, California, United States
ACCOMPLISH-1 Research Site
Gardena, California, United States
ACCOMPLISH-1 Research Site
La Jolla, California, United States
ACCOMPLISH-1 Research Site
Modesto, California, United States
ACCOMPLISH-1 Research Site
Rolling Hills Estates, California, United States
ACCOMPLISH-1 Research Site
San Diego, California, United States
ACCOMPLISH-1 Research Site
Clearwater, Florida, United States
ACCOMPLISH-1 Research Site
Leesburg, Florida, United States
ACCOMPLISH-1 Research Site
Miami, Florida, United States
ACCOMPLISH-1 Research Site
Ocala, Florida, United States
ACCOMPLISH-1 Research Site
Ocoee, Florida, United States
ACCOMPLISH-1 Research Site
Pembroke, Florida, United States
ACCOMPLISH-1 Research Site
Tampa, Florida, United States
ACCOMPLISH-1 Research Site
Buford, Georgia, United States
ACCOMPLISH-1 Research Site
Columbus, Georgia, United States
ACCOMPLISH-1 Research Site
Lawrenceville, Georgia, United States
ACCOMPLISH-1 Research Site
Union City, Georgia, United States
ACCOMPLISH-1 Research Site
Woodstock, Georgia, United States
ACCOMPLISH-1 Research Site
Honolulu, Hawaii, United States
ACCOMPLISH-1 Research Site
Meridian, Idaho, United States
ACCOMPLISH-1 Research Site
Rexburg, Idaho, United States
ACCOMPLISH-1 Research Site
Chicago, Illinois, United States
ACCOMPLISH-1 Research Site
Iowa City, Iowa, United States
ACCOMPLISH-1 Research Site
Wichita, Kansas, United States
ACCOMPLISH-1 Research Site
Louisville, Kentucky, United States
ACCOMPLISH-1 Research Site
Baton Rouge, Louisiana, United States
ACCOMPLISH-1 Research Site
Silver Spring, Maryland, United States
ACCOMPLISH-1 Research Site
Methuen, Massachusetts, United States
ACCOMPLISH-1 Research Site
Needham, Massachusetts, United States
ACCOMPLISH-1 Research Site
Ann Arbor, Michigan, United States
ACCOMPLISH-1 Research Site
Mankato, Minnesota, United States
ACCOMPLISH-1 Research Site
Richfield, Minnesota, United States
ACCOMPLISH-1 Research Site
Gulfport, Mississippi, United States
ACCOMPLISH-1 Research Site
Ridgeland, Mississippi, United States
ACCOMPLISH-1 Research Site
Chesterfield, Missouri, United States
ACCOMPLISH-1 Research Site
Hazelwood, Missouri, United States
ACCOMPLISH-1 Research Site
St Louis, Missouri, United States
ACCOMPLISH-1 Research Site
Butte, Montana, United States
ACCOMPLISH-1 Research Site
Missoula, Montana, United States
ACCOMPLISH-1 Research Site
Omaha, Nebraska, United States
ACCOMPLISH-1 Research Site
Las Vegas, Nevada, United States
ACCOMPLISH-1 Research Site
Albany, New York, United States
ACCOMPLISH-1 Research Site
Brooklyn, New York, United States
ACCOMPLISH-1 Research Site
Charlotte, North Carolina, United States
ACCOMPLISH-1 Research Site
Durham, North Carolina, United States
ACCOMPLISH-1 Research Site
Fayetteville, North Carolina, United States
ACCOMPLISH-1 Research Site
New Bern, North Carolina, United States
ACCOMPLISH-1 Research Site
Wilmington, North Carolina, United States
ACCOMPLISH-1 Research Site
Winston-Salem, North Carolina, United States
ACCOMPLISH-1 Research Site
Columbus, Ohio, United States
ACCOMPLISH-1 Research Site
Columbus, Ohio, United States
ACCOMPLISH-1 Research Site
Moore, Oklahoma, United States
ACCOMPLISH-1 Research Site
Portland, Oregon, United States
ACCOMPLISH-1 Research Site
Philadelphia, Pennsylvania, United States
ACCOMPLISH-1 Research Site
Greer, South Carolina, United States
ACCOMPLISH-1 Research Site
Knoxville, Tennessee, United States
ACCOMPLISH-1 Research Site
Austin, Texas, United States
ACCOMPLISH-1 Research Site
Austin, Texas, United States
ACCOMPLISH-1 Research Site
Denison, Texas, United States
ACCOMPLISH-1 Research Site
Houston, Texas, United States
ACCOMPLISH-1 Research Site
Houston, Texas, United States
ACCOMPLISH-1 Research Site
San Antonio, Texas, United States
ACCOMPLISH-1 Research Site
Wylie, Texas, United States
ACCOMPLISH-1 Research Site
Sandy City, Utah, United States
ACCOMPLISH-1 Research Site
St. George, Utah, United States
ACCOMPLISH-1 Research Site
Renton, Washington, United States