82 Participants Needed

GSBR-1290 for Obesity

(ACCESS II Trial)

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

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use medications intended to promote weight loss within 6 months before the trial.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use medications intended to promote weight loss within 6 months before joining the study.

What data supports the effectiveness of the treatment GSBR-1290 for obesity?

The research highlights that losing even 5% of body weight can have significant health benefits, and new medications for obesity treatment have been gaining interest. Although the studies focus on surgical methods like gastric bypass, they emphasize the importance of effective obesity treatments, suggesting that new therapies like GSBR-1290 could be promising.12345

What is the purpose of this trial?

Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various GSBR-1290 dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 36-week period.

Eligibility Criteria

This trial is for individuals who are living with obesity or overweight and have at least one weight-related health issue. Participants will also be following a diet and exercise plan during the study.

Inclusion Criteria

My BMI is 30 or higher, or it's 27 or higher with at least one obesity-related health issue.
Signed informed consent

Exclusion Criteria

I have been diagnosed with diabetes.
I have lost or gained more than 5% of my body weight in the last 3 months.
I have had or plan to have weight loss surgery, not including liposuction or tummy tuck over a year ago.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive various GSBR-1290 dose regimens or placebo, in addition to diet and exercise

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • GSBR-1290
Trial Overview The study is testing different doses of a drug called GSBR-1290 compared to a placebo, alongside diet and exercise, over 36 weeks to see its safety, how it's processed by the body, and its effectiveness in managing weight.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: SentinelExperimental Treatment1 Intervention
Participants will receive GSBR-1290 or Placebo administered orally.
Group II: Cohort 1cExperimental Treatment1 Intervention
Participants will receive GSBR-1290 or Placebo administered orally.
Group III: Cohort 1bExperimental Treatment1 Intervention
Participants will receive GSBR-1290 or Placebo administered orally.
Group IV: Cohort 1aExperimental Treatment1 Intervention
Participants will receive GSBR-1290 or 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

Trials
5
Recruited
530+

Findings from Research

In a study of 1,156 severely obese individuals, those who underwent Roux-en-Y gastric bypass surgery experienced significant improvements in BMI, blood pressure, lipids, and diabetes-related variables compared to those who did not have surgery.
The gastric bypass group also showed much higher rates of resolution for obesity-related conditions like diabetes, dyslipidemia, and hypertension, indicating that the surgery is highly effective for both weight loss and improving overall health outcomes after 2 years.
Health outcomes of gastric bypass patients compared to nonsurgical, nonintervened severely obese.Adams, TD., Pendleton, RC., Strong, MB., et al.[2021]
Gastric bypass surgery led to a significant reduction in body mass index (BMI) from 51.12 to 29.94 kg/m², resulting in a 72.85% loss of excess weight among 162 morbidly obese patients over a 2-year follow-up period.
The surgery also effectively resolved major comorbidities: hypertension in 71.93%, dyslipidemia in 91.38%, and type 2 diabetes in 82.93%, while significantly lowering cardiovascular risk from 25.91% to 4.32%.
[Effect of gastric bypass on the cardiovascular risk and quality of life in morbid obese patients].Mateo Gavira, I., Vílchez López, FJ., Cayón Blanco, M., et al.[2014]
In a study of 334 participants with simple obesity, those receiving acupuncture combined with diet control (observation group) showed a total effective rate of 91.8%, significantly higher than the 75.7% and 73.1% in the other control groups.
The acupuncture and diet control approach not only resulted in better weight loss outcomes but also had a lower rate of weight regain after one year compared to diet control alone, indicating its potential as a more sustainable treatment for obesity.
[Clinical observation on acupuncture combined with diet control for treatment of simple obesity].Chen, ZX.[2009]

References

Health outcomes of gastric bypass patients compared to nonsurgical, nonintervened severely obese. [2021]
[Effect of gastric bypass on the cardiovascular risk and quality of life in morbid obese patients]. [2014]
[Clinical observation on acupuncture combined with diet control for treatment of simple obesity]. [2009]
Obesity consults--comprehensive obesity management in 2013: understanding the shifting paradigm. [2018]
Rate of Acute Hospital Admissions Before and After Roux-en-Y Gastric Bypass Surgery: A Population-based Cohort Study. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security