Aleniglipron for Obesity

Not currently recruiting at 10 trial locations
MD
Overseen ByMedical Director
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called aleniglipron to assess its effects on body composition in individuals with obesity. Participants will take either aleniglipron or a placebo (a pill with no active drug) for 40 weeks. The goal is to determine if aleniglipron reduces body fat more effectively than the placebo. Suitable candidates for this trial are those with a BMI of 30 or higher, who have not experienced significant weight changes recently, and do not have diabetes. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that aleniglipron is likely to be safe for humans?

Research shows that aleniglipron is being tested as a treatment for obesity. Although detailed safety information for aleniglipron is not yet available, its progression to a Phase 2 trial indicates it has passed initial safety checks. Phase 2 trials primarily assess how well participants tolerate the treatment and identify potential side effects.

Similar studies with drugs like aleniglipron, known as GLP-1 receptor agonists, have shown that treatments are usually well-tolerated. However, some individuals might experience mild to moderate side effects, such as nausea or diarrhea, which are common with these medications. The ongoing research aims to gather more detailed information on aleniglipron's safety and effectiveness, with participants closely monitored throughout the study.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about aleniglipron for obesity because it represents a potential new approach in a field dominated by lifestyle changes, medications like orlistat, and GLP-1 receptor agonists such as semaglutide. Aleniglipron is unique because it may work by targeting different pathways in the body to help regulate weight, potentially offering an alternative mechanism of action compared to existing treatments. Additionally, its oral administration could provide a more convenient option for patients compared to injectable therapies, making it a promising candidate in the fight against obesity.

What evidence suggests that aleniglipron might be an effective treatment for obesity?

Research has shown that aleniglipron, a treatment under study for obesity, yields promising results. In an earlier study, 67% of participants taking aleniglipron lost at least 6% of their weight, and 33% lost at least 10% by week 12. In contrast, none of the participants taking a placebo achieved these weight loss goals. In this trial, participants will receive either aleniglipron or a placebo to further evaluate its effectiveness. Aleniglipron helps control appetite and weight. These early findings suggest it could be a strong option for those seeking assistance with weight management.12346

Are You a Good Fit for This Trial?

This trial is for individuals with obesity, including childhood obesity. Participants will be chosen to receive either the study drug aleniglipron or a placebo without knowing which one they're getting. The ratio of participants receiving aleniglipron to placebo is 5:1.

Inclusion Criteria

Screening HbA1c <6.5%
Signed informed consent
I am between 18 and 79 years old with a BMI of 30 or higher.

Exclusion Criteria

Have a body weight, height, and/or width that prohibits the ability to obtain accurate measurements according to the DXA study specific manual that allows hemi-scan
I have been diagnosed with diabetes.
I have lost or gained more than 5% of my body weight in the last 3 months.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple ascending QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 40 weeks

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aleniglipron
Trial Overview The study tests the effects of aleniglipron on body composition over a period of 40 weeks. It involves increasing doses every four weeks in a double-blind setup, meaning neither the researchers nor participants know who's receiving the actual drug or placebo.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Group II: Cohort 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Lead Sponsor

Trials
5
Recruited
530+

Citations

NCT06693843 | A Phase 2b, Dose-range Finding Study of ...Study Plan ; Percentage of participants who achieve ≥10% reduction in body weight at Week 36, Baseline and week 36 ; Percentage of participants who achieve ≥15% ...
Structure Therapeutics Reports Second Quarter 2025 ...Topline data from oral small molecule GLP-1 receptor agonist aleniglipron ACCESS and ACCESS II studies on track for year-end 2025 readouts.
Aleniglipron Phase 2 Body Composition Study... data for the primary outcome measure. Whether the clinical study ended ... obesity, overweight, GSBR-1290, aleniglipron, chronic weight management ...
Orforglipron, an Oral Small-Molecule GLP-1 Receptor ...In adults with obesity, 72-week treatment with orforglipron led to significantly greater reductions in body weight than placebo; the adverse- ...
Press ReleaseAt Week 12, 67% of GSBR-1290 treated participants achieved ≥6% weight loss and 33% achieved ≥ 10% weight loss, compared to 0% for placebo. A ...
99.1ACCESS II enrolled approximately 80 adults living with obesity, or overweight with at least one weight-related comorbidity, and is designed to ...
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