Aleniglipron for Diabetes and 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 determine its effectiveness for people with type 2 diabetes who are overweight or obese. Researchers aim to assess the long-term safety and efficacy of aleniglipron. Participants will receive either aleniglipron or a placebo (a harmless pill with no active ingredient) for about 76 weeks, assigned randomly. The trial seeks individuals diagnosed with type 2 diabetes and a BMI of 27 or higher. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Do I have to stop taking 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 has shown that aleniglipron is generally safe, based on data from over 625 participants in various studies. Notably, no cases of liver damage linked to the drug were reported. Approximately 10.4% of participants discontinued the treatment due to side effects, indicating that most people tolerated aleniglipron well. These findings suggest the treatment is generally safe and well-tolerated, with side effects similar to other drugs in its group, known as GLP-1 receptor agonists.12345
Why do researchers think this study treatment might be promising?
Aleniglipron is unique because it targets both diabetes and obesity with a fresh approach. Unlike most diabetes treatments that focus on insulin regulation or glucose absorption, aleniglipron may work through a new mechanism that directly impacts metabolic processes linked to both conditions. This could mean better overall management of blood sugar levels and weight, potentially simplifying treatment for patients dealing with both issues simultaneously. Researchers are excited because this dual-action approach might offer a more comprehensive solution than the current standard therapies, like metformin or GLP-1 receptor agonists, which typically address one condition primarily.
What evidence suggests that aleniglipron might be an effective treatment for diabetes and obesity?
Research has shown that aleniglipron yields promising results for people with type 2 diabetes and obesity. In earlier studies, participants lost a significant amount of weight. For example, one study found an average weight loss of 16.3% (about 39 pounds), which exceeded the weight loss of those who took a placebo. Other studies reported weight loss between 11.3% and 14.7%. This treatment helps control blood sugar and reduce appetite, leading to weight loss. These findings highlight its potential as an effective treatment for managing weight in people with diabetes and obesity. Participants in this trial will receive aleniglipron or a placebo to further evaluate its effectiveness.12367
Are You a Good Fit for This Trial?
This trial is for adults who are overweight or have obesity (BMI of 27 or higher) and have type 2 diabetes with moderately high blood sugar. People can't join if their weight changed a lot recently, they had severe low blood sugar episodes, eye treatments for diabetes, other types of diabetes, or past/planned weight loss surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either aleniglipron or placebo for chronic weight management
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 aleniglipron versus a placebo in adults with overweight/obesity and type 2 diabetes. Participants are randomly assigned to either the drug or placebo group without knowing which one they're getting. Treatment lasts about 76 weeks.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
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
Oral small molecule GLP-1 receptor agonist aleniglipron in ...
−12.4% body weight loss by 72 weeks ・ clinically meaningful reductions in the three aleniglipron arms, ranging from −28.8% to −46.4%, compared ...
2.
ir.structuretx.com
ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-phase-2/Press Release
aleniglipron achieved clinically meaningful and statistically significant placebo-adjusted mean weight loss of 16.3% (39 lbs; p<0.0001) at the ...
NCT07400588 | Aleniglipron Phase 2 in Type 2 Diabetes ...
Aleniglipron Phase 2 in Type 2 Diabetes Mellitus … endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and ...
4.
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 ...
aleniglipron demonstrated a substantial and statistically significant placebo-adjusted mean weight reduction of 16.3% (39 lbs; P<0.001) at 180 ...
5.
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 ...
Aleniglipron Phase 2 in Type 2 Diabetes Mellitus
The purpose of this study is to assess the safety and tolerability of aleniglipron at doses up to 240 mg once daily (QD) in participants ...
NCT07654361 | Efficacy and Safety of Aleniglipron in ...
study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo,
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