Aleniglipron for Diabetes
(GSBR-1290 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, aleniglipron, to evaluate its safety and effectiveness for individuals with type 2 diabetes who are also overweight or obese. Participants will take either aleniglipron or a placebo pill (a pill resembling the medicine but without active ingredients) to compare effects. The study seeks individuals who have had type 2 diabetes for at least six months, have a BMI over 27, and do not plan to receive certain treatments that could affect their diabetes or weight. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but you cannot take any drugs that could interfere with glucose levels.
Is there any evidence suggesting that aleniglipron is likely to be safe for humans?
Research shows that aleniglipron is likely safe. Studies found no cases of liver damage caused by the drug, which is reassuring since liver health often concerns new treatments. Aleniglipron has been tested in doses up to 240 mg daily, and most participants did not experience serious side effects, indicating it was well-tolerated.
Additionally, other studies examined aleniglipron's effects on blood sugar levels and weight loss in people with type 2 diabetes. While these studies focused on the drug's efficacy, they also provided more information about its safety. Overall, the evidence suggests that aleniglipron is generally safe for use at the tested doses.12345Why do researchers think this study treatment might be promising?
Unlike the standard diabetes treatments, which often include medications like metformin, sulfonylureas, or insulin, aleniglipron is unique because it is a new oral drug that may offer a different mechanism of action. While most diabetes treatments work by increasing insulin sensitivity or stimulating insulin release, aleniglipron targets different pathways to potentially improve blood sugar control. Researchers are excited about aleniglipron because it could provide an alternative option for patients who do not respond well to existing therapies, and it might have a favorable side effect profile compared to current medications.
What evidence suggests that aleniglipron might be an effective treatment for diabetes?
Research has shown that aleniglipron, which participants in this trial may receive, can help people with type 2 diabetes lose weight. One study found that people taking a 240 mg dose lost up to 15.3% of their body weight compared to those taking a placebo, which contains no active medicine. Another study showed that after 36 weeks, 86% of people taking a 120 mg dose lost at least 5% of their body weight, and 70% lost 10% or more. These findings suggest that aleniglipron could be a promising option for weight management in people with type 2 diabetes who are also overweight or have obesity.12345
Are You a Good Fit for This Trial?
This trial is for adults with Type 2 Diabetes Mellitus (T2DM) who are overweight or obese, with a BMI of at least 27 kg/m2. They must have been diagnosed with T2DM for over six months and have an HbA1c level between 6.5% to ≤10%. Participants should not have had significant weight changes recently, no obesity surgery except certain procedures over a year ago, and stable diabetic eye conditions.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 orally once daily
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 the safety and tolerability of aleniglipron up to doses of 240 mg daily in people with T2DM who are also overweight or obese. It compares the effects of aleniglipron against a placebo to see how well it works.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Drug placebo administered orally
Drug aleniglipron 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
1.
ir.structuretx.com
ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-accessPress Release
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 ...
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 with T2DM who are ...
Structure Therapeutics announces positive results from ...
After 36 weeks, 86% of those receiving the 120mg dose achieved a minimum of 5% weight loss while 70% reported weight loss of at least 10%. In ...
4.
velocityclinical.com
velocityclinical.com/positive-topline-results-announced-for-access-studies-for-aleniglipron-oral-glp-1-ra/Positive Topline Results Announced for ACCESS Studies ...
Phase 2b ACCESS study: 120 mg dose → 11.3% mean weight loss (~27 lbs) at 36 weeks · Exploratory ACCESS II study: 240 mg dose → up to 15.3% mean ...
Small-Molecule GLP-1 Receptor Agonists - PMC - NIH
Peak pharmacodynamic effects occurred at relatively low plasma concentrations: 24 ± 8 nmol/L (0.1 mg/kg), 205 ± 18 nmol/L (1 mg/kg), and 1257 ± ...
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