Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)
Recruiting · NCT07654361 · Interventional (participants receive a specific treatment) · Lead sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
AleniglipronPlacebo
What this trial is about
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.
Who can take part
Age range
18 Years to 79 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Signed informed consent
- BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.
Exclusion criteria
- Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes.
- Self-reported change in body weight \>5 kg within 3 months before Screening.
- Have prior or planned surgical or non-surgical treatment for obesity.
- Have or plan to have endoscopic and/or device-based therapy for obesity.
- Have obesity induced by other endocrine disorders.
- Impaired renal function at Screening
- Chronic malabsorption
Where it is running
60 locations listed across 32 US states.
- 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
Showing 60 of 71 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →