GSBR-1290 for Obesity

(ACCESS II Trial)

Not currently recruiting at 14 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

Must not be taking: Weight loss medications

Disqualifiers: Diabetes, Recent weight change, 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 evaluates the safety and effectiveness of a new treatment, GSBR-1290, for individuals with obesity. The research examines various doses of GSBR-1290 to assess its efficacy alongside diet and exercise over 44 weeks. Participants will receive either the treatment or a placebo (a harmless pill resembling the treatment) to compare results. Ideal participants have a BMI of 30 or higher, or a BMI of 27 or higher with a weight-related health issue. As a Phase 2 trial, this research focuses on measuring 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 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.

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

Research has shown that GSBR-1290 is generally safe and well-tolerated. In one study, over 200 people took GSBR-1290 for up to 12 weeks, and the safety results matched earlier findings, indicating a wide safety margin. Another study involving individuals with Type 2 diabetes also found that GSBR-1290 was well-tolerated. These results suggest that GSBR-1290 is generally well-tolerated in humans. However, as this is an ongoing Phase 2 study, additional data will help confirm its safety. ^{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 offers a fresh approach compared to traditional treatments. Most current obesity medications work by suppressing appetite or altering fat absorption, but GSBR-1290 operates differently, potentially targeting metabolic pathways that regulate energy balance. This distinct mechanism might lead to more effective weight management with fewer side effects. Additionally, GSBR-1290 is administered orally, which could make it more convenient and appealing for patients compared to other treatment forms.

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

Research has shown that GSBR-1290 is a promising weight loss treatment. In a recent study, 67% of participants taking GSBR-1290 lost at least 6% of their body weight, and 33% lost 10% or more. In contrast, none of the participants taking a placebo achieved these results. GSBR-1290 mimics a natural hormone in the body that reduces hunger and increases feelings of fullness. This promising evidence suggests that GSBR-1290 could effectively aid weight loss in people with obesity. Participants in this trial will receive either GSBR-1290 or a placebo to further evaluate its effectiveness. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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

Signed informed consent

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Sentinel Experimental Treatment 1 Intervention

Participants will receive aleniglipron or placebo administered orally.

Group II: Cohort 1c Experimental Treatment 1 Intervention

Participants will receive aleniglipron or placebo administered orally.

Group III: Cohort 1b Experimental Treatment 1 Intervention

Participants will receive aleniglipron or placebo administered orally.

Group IV: Cohort 1a Experimental Treatment 1 Intervention

Participants will receive aleniglipron 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 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]

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]

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]

Losing just 5% of body weight can lead to significant health improvements, but many individuals struggle to maintain weight loss through diet and exercise alone, highlighting the need for additional treatment options.

As of 2012, two new medications, lorcaserin and phentermine/topiramate, have been approved for long-term obesity treatment, and bariatric surgery is recommended for patients with severe obesity (BMI ≥40 or ≥35 with comorbidities) as a more intensive intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity consults--comprehensive obesity management in 2013: understanding the shifting paradigm. Kushner, RF., Apovian, CM., Fujioka, K.[2018]

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]

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 GSBR-1290 is an orally-available, nonpeptide small molecule glucagon-like-peptide-1 receptor (GLP-1R) agonist that has demonstrated competitive weight loss and ...

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

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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06139055

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-and

767-P: Phase 1b/2a Study of GSBR-1290 GLP-1RA Safety Conclusions: GSBR-1290 demonstrated favorable safety and tolerability in this Phase 1b/2a study in participants with T2DM and in HOV. GSBR-1290 ...