GSBR-1290 for Obesity

(ACCESS Trial)

Not currently recruiting at 38 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called aleniglipron (also known as GSBR-1290) to evaluate its effectiveness for people with obesity. Researchers aim to determine the treatment's safety and tolerability, as well as its effects on the body, by comparing it to a placebo (a non-active substance). Participants will receive varying doses over time to identify the most effective one. This trial suits individuals with a BMI of 30 or higher, or a BMI of 27 or higher with a weight-related health issue like high blood pressure. As a Phase 2 trial, the 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 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.

Is there any evidence suggesting that GSBR-1290 is likely to be safe for humans?

Research has shown that GSBR-1290 has promising safety results from past studies. In one study, participants reported no liver problems, and no one stopped treatment due to side effects. Another study found that GSBR-1290 was well-tolerated by people with type 2 diabetes and healthy volunteers. These findings suggest that the treatment is generally safe, making it a potentially good option for those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about GSBR-1290 for obesity because it represents a novel approach to weight management. Unlike traditional treatments that primarily focus on appetite suppression or fat absorption, GSBR-1290 uses a unique mechanism targeting specific metabolic pathways to promote weight loss. This could potentially lead to more effective and sustainable results. Additionally, GSBR-1290 is administered orally, offering a convenient alternative to injectable treatments. This innovative approach has the potential to address obesity more effectively by tackling root causes rather than just symptoms.

What evidence suggests that GSBR-1290 might be an effective treatment for obesity?

Research has shown that GSBR-1290, also known as aleniglipron, may aid in weight loss. In a previous study, 67% of participants taking GSBR-1290 lost at least 6% of their body weight, and 33% lost at least 10%. In contrast, no participants in the placebo group achieved similar weight loss. Additionally, GSBR-1290 has been shown to lower body weight, blood sugar levels, and HbA1c, a measure of average blood sugar over time. This trial will evaluate the effectiveness of GSBR-1290, with participants receiving either aleniglipron or a placebo. This evidence suggests that GSBR-1290 could be effective for individuals struggling with overweight or obesity. ^{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 Aleniglipron or Placebo administered orally.

Group II: Cohort 2 Experimental Treatment 1 Intervention

Participants will receive Aleniglipron or Placebo administered orally.

Group III: Cohort 1 Experimental Treatment 1 Intervention

Participants will receive Aleniglipron or Placebo administered orally.

Group IV: Cohort 1 OLE Active Control 1 Intervention

Participants will receive Aleniglipron administered orally

Group V: Cohort 2 OLE Active Control 1 Intervention

Participants will receive Aleniglipron administered orally

Group VI: Cohort 3 OLE Active Control 1 Intervention

Participants will receive Aleniglipron administered orally

Group VII: Cohort 4 OLE Active Control 1 Intervention

Participants will receive Aleniglipron 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 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]

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]

Citations

1. ir.structuretx.com ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-its-phase

Press 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-2b

Press Release - Structure Therapeutics ACCESS is a randomized, double-blind, placebo-controlled, Phase 2b dose-range finding study of GSBR-1290 in approximately 220 adult participants ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06703021

A Dose-Range Study of Aleniglipron (GSBR-1290) in ... Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (GSBR-1290) dose regimens compared ...

4. ir.structuretx.com ir.structuretx.com/static-files/775ca535-9bd3-455e-a41a-44dea273c90d

GSBR-1290 Obesity Topline Data Presentation D. Chief Executive Officer. GSBR-1290 Obesity Topline Data. • Efficacy Summary. • Safety and Tolerability Summary. • Pharmacokinetic ( ...

5. diabetesjournals.org diabetesjournals.org/diabetes/article/73/Supplement_1/767-P/156359/767-P-A-Phase-1b-2a-Study-of-the-Safety-and

A Phase 1b/2a Study of the Safety and Tolerability of GSBR ... GSBR-1290 demonstrated clinical benefits in lowering BW, blood glucose, and HbA1c. These data provide clinical proof-of-concept of GSBR-1290 ...