GSBR-1290 for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment, GSBR-1290, to assess its safety and tolerability in individuals who are overweight or obese. Researchers compare different forms of this treatment, such as capsules and tablets, to determine how the body absorbs them. Participants will receive either the treatment or a placebo (a pill with no active ingredient) over 12 weeks. The trial seeks individuals who are overweight or obese, with a Body Mass Index (BMI) of 27 or higher, and who do not have major health issues like heart or liver disease. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Do I have to stop taking my current medications for the GSBR-1290 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 this trial's treatments are likely to be safe?
Research has shown that GSBR-1290 was safe in earlier studies. One study reported no cases of liver damage or long-term increases in liver enzyme levels, indicating that the treatment does not cause liver issues, a positive sign for safety. Additionally, no participants withdrew due to side effects, suggesting the treatment was well-tolerated. Another study involving individuals with type 2 diabetes and healthy overweight volunteers also found GSBR-1290 to be safe and well-tolerated. These results suggest that GSBR-1290 is likely safe for participants in the trial.12345
Why do researchers think this study treatment might be promising for obesity?
Most treatments for obesity, like lifestyle changes, medications such as orlistat, and bariatric surgery, aim to reduce calorie intake or alter digestion. But GSBR-1290 is different because it offers a novel approach with its oral tablet and capsule formulations. Researchers are excited about GSBR-1290 as it could provide an alternative that is easier to adhere to, with potentially fewer side effects and a more convenient daily dosing regimen. Additionally, the possibility of switching between tablets and capsules offers flexibility that might better suit individual patient preferences and needs.
What evidence suggests that this trial's treatments could be effective for obesity?
Research has shown that GSBR-1290 might help people who are overweight or obese lose weight. One study found that 67% of participants taking GSBR-1290 lost at least 6% of their body weight after 12 weeks, and 33% lost 10% or more. None of the participants taking a placebo lost this much weight. GSBR-1290 helps control appetite and weight, suggesting it could be a strong option for managing weight. Participants in this trial will receive either GSBR-1290 or a placebo to further evaluate its effectiveness.13467
Are You a Good Fit for This Trial?
This clinical trial is for healthy adult men and women who are overweight or obese, aged between 18 to 75 years old with a BMI of at least 27.0 kg/m^2. Participants must understand the study procedures and agree to follow them by signing an informed consent form.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive a single dose of GSBR-1290 oral capsule or tablet in a crossover design
Treatment Part 2
Participants receive GSBR-1290 or placebo tablets once daily for 12 weeks, with further randomization in the last 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GSBR-1290
Trial Overview
The trial is testing GSBR-1290, a new medication in capsule/tablet form, against a placebo (a pill with no active drug) to assess its safety and how it's processed by the body when given repeatedly to healthy overweight/obese individuals.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks. In the last 4 weeks, participants will be further randomized to GSBR-1290 capsules or tablets or matching-placebo at Week 9 to 10 followed by alternate (capsule or tablet) formulation of either GSBR-1290 or placebo at Week 11 to 12.
Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks.
Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks.
Participants will receive a single dose of GSBR-1290 oral tablet formulation on Day 1 in Treatment Period 1 followed by GSBR-1290 oral capsule formulation on Day 8 (Day 1 of Treatment Period 2).
Participants will receive a single dose of GSBR-1290 oral capsule formulation on Day 1 in Treatment Period 1 followed by GSBR-1290 oral tablet formulation on Day 8 (Day 1 of Treatment Period 2).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gasherbrum Bio, Inc
Lead Sponsor
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-its-phasePress Release
At Week 12, 67% of GSBR-1290 treated participants achieved ≥6% weight loss and 33% achieved ≥ 10% weight loss, compared to 0% for placebo. A ...
2.
structuretx.gcs-web.com
structuretx.gcs-web.com/news-releases/news-release-details/structure-therapeutics-announces-first-patients-dosed-phase-2bPress Release - Structure Therapeutics
GSBR-1290 is an orally-available, nonpeptide small molecule glucagon-like-peptide-1 receptor (GLP-1R) agonist that has demonstrated competitive weight loss and ...
GSBR-1290 Obesity Topline Data Presentation
GSBR-1290 Obesity Topline Results. Efficacy Summary. Page 7. 7. GSBR-1290 Phase 2a Study Design in Overweight or Obese Participants. 5 mg. 15 mg 30 mg 60 mg. 90 ...
A Study of Multiple-ascending Doses of GSBR-1290 in ...
The purpose of this study is to compare the safety, tolerability, pharmacokinetic (PK), and comparative bioavailability of repeated administration of GSBR-1290 ...
5.
biopharmadive.com
biopharmadive.com/news/structure-obesity-pill-drug-trial-results-weight-loss/717768/Structure pill leads to competitive weight loss in obesity study
One-third of those on the drug, dubbed GSBR-1290, lost 10% or more of their body weight, compared to zero of those given placebo.
6.
diabetesjournals.org
diabetesjournals.org/diabetes/article/73/Supplement_1/767-P/156359/767-P-A-Phase-1b-2a-Study-of-the-Safety-andA Phase 1b/2a Study of the Safety and Tolerability of GSBR ...
Conclusions: GSBR-1290 demonstrated favorable safety and tolerability in this Phase 1b/2a study in participants with T2DM and in HOV. GSBR-1290 ...
NCT06693843 | A Phase 2b, Dose-range Finding Study of ...
This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses ...
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