GSBR-1290 for Obesity

(ACCESS Trial)

Recruiting at 37 trial locations

Overseen By Medical Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Disqualifiers: Diabetes, Weight change, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses of GSBR-1290 in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to GSBR-1290 or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of GSBR-1290 or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment.

Will I have to stop taking my current medications?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

The research on combination therapies for obesity suggests that drugs affecting hormones like GLP-1, which are involved in digestion and appetite, have shown promise in treating obesity. This indicates that GSBR-1290, if it works similarly, might also be effective. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults with obesity (BMI ≥30) or overweight (BMI ≥27) who also have a weight-related health issue. They must not weigh less than 80 kg, have had certain obesity surgeries, diabetes, or significant weight changes recently.

Inclusion Criteria

Signed informed consent

My BMI is 30 or higher, or it's above 27 with a condition related to obesity.

Exclusion Criteria

I have had or am planning to have weight loss surgery, not including liposuction or tummy tucks done over a year ago.

I have been diagnosed with diabetes.

I have lost or gained more than 5% of my body weight in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple-ascending, QD doses of GSBR-1290 or placebo in titration steps of 4 weeks duration for a total of 36 weeks

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GSBR-1290

Trial Overview The study tests the effectiveness and safety of GSBR-1290 compared to a placebo in treating obesity. Participants will receive either the drug or placebo over 36 weeks with doses increasing every four weeks.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 1 Intervention

Participants will receive GSBR-1290 or Placebo administered orally.

Group II: Cohort 2 Experimental Treatment 1 Intervention

Participants will receive GSBR-1290 or Placebo administered orally.

Group III: Cohort 1 Experimental Treatment 1 Intervention

Participants will receive GSBR-1290 or Placebo administered orally.

Who Is Running the Clinical Trial?

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Lead Sponsor

Trials

5

Recruited

530+

Published Research Related to This Trial

In a study of 9,985 patients who underwent Roux-en-Y gastric bypass (RYGB) surgery in Denmark, 3.3% experienced surgical complications within 30 days, and 23.9% had complications during a median follow-up of 4.2 years, indicating a significant risk of long-term issues post-surgery.

After RYGB, the rate of hospital admissions for patients increased significantly compared to a matched general population, with a rate ratio of 3.38, highlighting the need for careful monitoring and management of potential complications such as anemia and self-harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Acute Hospital Admissions Before and After Roux-en-Y Gastric Bypass Surgery: A Population-based Cohort Study. Gribsholt, SB., Svensson, E., Richelsen, B., et al.[2019]

Combination therapies for obesity treatment, such as pramlintide with phentermine and GLP-1 with glucagon, show promising efficacy beyond traditional diet and lifestyle changes.

Recent trials indicate that combining intragastric balloon treatments with GLP-1 analogs like liraglutide may enhance weight loss outcomes, suggesting a potential new direction for obesity management in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination Therapies for Obesity. Camilleri, M., Acosta, A.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health outcomes of gastric bypass patients compared to nonsurgical, nonintervened severely obese. Adams, TD., Pendleton, RC., Strong, MB., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical observation on acupuncture combined with diet control for treatment of simple obesity]. Chen, ZX.[2009]

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%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Rate of Acute Hospital Admissions Before and After Roux-en-Y Gastric Bypass Surgery: A Population-based Cohort Study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Combination Therapies for Obesity. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Health outcomes of gastric bypass patients compared to nonsurgical, nonintervened severely obese. [2021]

4. China pubmed.ncbi.nlm.nih.gov

[Clinical observation on acupuncture combined with diet control for treatment of simple obesity]. [2009]

5. Spain pubmed.ncbi.nlm.nih.gov

[Effect of gastric bypass on the cardiovascular risk and quality of life in morbid obese patients]. [2014]