NCT07654361 · Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)
What this study is about
Study GSBR-1290-12 is a Phase 3 pivotal, conducted at multiple hospitals, global, randomly assigned, compared against an inactive treatment, where neither patients nor doctors know which treatment is given study to investigate the long-term effectiveness, 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 randomly assigned 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.
View original scientific description
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.
Interventions
DRUG
Aleniglipron
Drug: aleniglipron administered orally Drug
DRUG
Placebo
Drug: placebo administered orally
Primary outcome measures
Percent change in body weight from Baseline
Time frame: Baseline and Week 76
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
- Phoenix, Arizona
- Sun City West, Arizona
- Tucson, Arizona
- Escondido, California
- Gardena, California
- La Jolla, California
- Modesto, California
- Rolling Hills Estates, California
- San Diego, California
- Clearwater, Florida
- Leesburg, Florida
And 55 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 10, 2026 · Source of record for eligibility and locations