Aleniglipron for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called aleniglipron to help people lose weight and maintain weight loss. Participants will take either aleniglipron or a placebo while following a diet and exercise plan for about 76 weeks. The trial aims to evaluate the effectiveness and safety of aleniglipron for long-term weight loss and its effects on blood pressure and cholesterol. Individuals who are obese or overweight with obesity-related health issues may be suitable for this study. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants an opportunity to contribute to the development of a promising new treatment.
Is there any evidence suggesting that aleniglipron is likely to be safe for humans?
Research has shown that aleniglipron was tested in earlier studies with promising safety results. In these studies, the treatment significantly reduced body weight without major safety concerns. Specifically, participants taking a 240 mg dose lost up to 15.3% more weight than those on a placebo, with no serious safety issues reported.
Further research has examined its effects on blood pressure and cholesterol levels, which ongoing studies will continue to monitor. The current trial is in a late stage, indicating that earlier phases have generally demonstrated the treatment's safety. While this study will provide more detailed safety information, past findings suggest aleniglipron is safe for humans.12345Why do researchers think this study treatment might be promising?
Aleniglipron is unique because it targets obesity through a novel mechanism of action. Unlike most current treatments, which primarily focus on appetite suppression or calorie absorption reduction, aleniglipron works by modulating the body's metabolic processes, potentially leading to more effective and sustainable weight loss. Researchers are excited about aleniglipron because it offers a new approach that could complement or enhance existing therapies, providing patients with additional options for managing obesity.
What evidence suggests that aleniglipron might be an effective treatment for obesity?
Research has shown that aleniglipron, an oral medication, offers promising results for weight loss. In one study, 86% of participants taking 120 mg of aleniglipron lost at least 5% of their body weight. Another study found participants lost up to 14.7% of their weight, comparable to results with injections. A study with a higher dose demonstrated up to 15.3% weight loss compared to a placebo. These findings suggest that aleniglipron could effectively aid weight loss in individuals with obesity. Participants in this trial will receive varying dosages of aleniglipron or a placebo to further assess its effectiveness.12346
Are You a Good Fit for This Trial?
This trial is for adults who are obese (BMI of 30 or higher) or overweight (BMI of 27 or higher) with at least one weight-related health issue. People with recent major weight changes, diabetes, kidney problems, certain surgeries for obesity, or other specific medical conditions cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive aleniglipron or placebo once daily for at least 76 weeks, combined with a reduced-calorie diet and increased physical activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aleniglipron
Trial Overview
The study tests three different daily doses of a new drug called aleniglipron versus a placebo. All participants also follow a reduced-calorie diet and exercise plan. The goal is to see how well the drug helps with long-term weight loss and its effects on blood pressure and cholesterol over about 1.5 years.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive aleniglipron administered orally.
Participants will receive aleniglipron administered orally.
Participants will receive aleniglipron administered orally.
Participants will receive placebo administered orally.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Lead Sponsor
Citations
NCT07654361 | Efficacy and Safety of Aleniglipron in ...
the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.
2.
clinicaltrialvanguard.com
clinicaltrialvanguard.com/article/intel-brief/alenigliprons-phase-2b-data-redraws-the-oral-glp-1-efficacy-map-and-raises-hard-questions-for-phase-3-design/Aleniglipron's Phase 2b Data Redraws the Oral GLP-1 ...
Structure Therapeutics' aleniglipron hit 14.7% weight loss in Phase 2b, matching injectable benchmarks. Here's what the trial design signals ...
3.
ir.structuretx.com
ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-phase-2/Press Release
Additionally, at a 2.5 mg start and after a median follow up of 20 weeks (~ 30 mg titration step) aleniglipron showed a 6.8% weight loss. ACCESS ...
Oral small molecule GLP-1 receptor agonist aleniglipron in ...
Of note, 86% of participants randomized to the 120-mg aleniglipron arm had a body-weight reduction of at least 5%, the recommended cut-off in ...
5.
docwirenews.com
docwirenews.com/post/aleniglipron-shows-positive-phase-2-access-ii-results-in-once%E2%80%91daily-oral-glp%E2%80%911-trialAleniglipron Shows Positive Phase 2 ACCESS II Results in ...
In the ACCESS OLE study, aleniglipron continued to facilitate weight reduction from 36 weeks onward, attaining up to 16.2% (40.5 lbs) with the ...
Untitled
In the exploratory ACCESS II study, aleniglipron achieved a placebo-adjusted mean weight loss up to 15.3% (35.5 lbs, p<0.0001) with 240 mg dose ...
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