GSBR-1290 for Obesity and Type 2 Diabetes

No longer recruiting at 3 trial locations

Overseen By Clinical Operations Lead

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

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

Must be taking: Metformin

Disqualifiers: Cardiovascular, Pulmonary, Hepatic, Renal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment, GSBR-1290, for individuals who are overweight or obese and those with Type 2 Diabetes (T2DM) taking Metformin. The study will evaluate the safety and tolerability of the treatment, as well as how the body processes and reacts to it. Participants will be divided into groups to receive either GSBR-1290 or a placebo over several weeks. Ideal candidates are adults with a BMI between 27 and 40 who either have T2DM and are already on Metformin or are healthy but overweight or obese. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you have Type 2 Diabetes and are on metformin, you must continue taking it at stable doses.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that GSBR-1290 is generally safe for people with obesity and Type 2 Diabetes. An earlier study found GSBR-1290 to be well-tolerated, with most participants experiencing no issues. The treatment did not cause any serious side effects. Only a small number of participants (2.8%) left the study early, and this was unrelated to the treatment. Additionally, there were no harmful effects on the liver, such as lasting increases in liver enzymes.

Overall, these findings suggest that GSBR-1290 is safe and well-tolerated in humans, making it a promising option for further research in treating obesity and Type 2 Diabetes. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

GSBR-1290 is unique because it offers a fresh approach to treating obesity and type 2 diabetes. Unlike current treatments that primarily focus on controlling symptoms or insulin levels, GSBR-1290 may work through a new mechanism targeting the underlying pathways of these conditions, potentially improving metabolic health more effectively. Researchers are excited because this could mean better management of weight and blood sugar levels, offering hope for patients who haven't found success with existing medications. Plus, with its potential for faster results, GSBR-1290 might provide noticeable benefits in just weeks, a promising prospect for those in need of more immediate relief.

What evidence suggests that this trial's treatments could be effective for obesity and Type 2 diabetes?

Previous studies have shown that GSBR-1290 helps with weight loss and blood sugar management. About 67% of participants taking GSBR-1290 lost at least 6% of their body weight after 12 weeks, while around 33% lost 10% or more. In contrast, those given a placebo (a fake treatment) did not experience these results. The treatment also lowered blood sugar and HbA1c levels, which are important for managing diabetes. These findings suggest that GSBR-1290 could be effective for people with obesity and type 2 diabetes. Participants in this trial will be randomized to receive either GSBR-1290 or a placebo to further evaluate these effects. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who are overweight or obese with a BMI of 27-40 kg/m2, and those with Type 2 Diabetes Mellitus on stable metformin treatment. Participants should not use nicotine, have good venous access for blood sampling, and no significant health issues like heart or kidney disease.

Inclusion Criteria

Your body mass index (BMI) is between 27 and 40.

You cannot use any nicotine products if you are in Cohorts 1-4.

I have had type 2 diabetes for at least 6 months.

Exclusion Criteria

I have a history of heart rhythm problems or abnormal ECG results.

My blood pressure is high or my heart rate is too low or too high after resting.

My liver tests are more than twice the normal limit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple-ascending doses of GSBR-1290 or Placebo

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GSBR-1290
• Placebo

Trial Overview The study tests GSBR-1290's safety and effects compared to a placebo in overweight/obese individuals and those with Type 2 Diabetes over three months. It will look at how the body processes the drug (PK) and its impact on the body (PD).

How Is the Trial Designed?

Group I: Cohort 5 Experimental Treatment 2 Interventions

Participants with T2DM(Cohort 5) will be randomized to placebo, low-dose, or high-dose arms. Participants in the low-dose, high-dose or placebo arms will receive multiple-ascending doses for 12 weeks

Group II: Cohort 4 Experimental Treatment 2 Interventions

HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks

Group III: Cohort 3 Experimental Treatment 2 Interventions

Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks

Group IV: Cohort 2 Experimental Treatment 2 Interventions

Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks

Group V: Cohort 1 Experimental Treatment 2 Interventions

Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

5

Recruited

530+

Gasherbrum Bio, Inc

Lead Sponsor

Trials

3

Recruited

230+

Published Research Related to This Trial

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]

Three FDA-approved medications for long-term obesity treatment—sibutramine, orlistat, and rimonabant—have shown significant weight loss benefits in large clinical trials lasting 2 to 4 years, with average weight loss of 8%-10% compared to 4%-6% for placebo.

While all medications have side effects, sibutramine can increase blood pressure and heart rate, orlistat can cause gastrointestinal issues like steatorrhea, and rimonabant generally has a favorable safety profile with mild, self-limited nausea and gastrointestinal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug treatment of the overweight patient. Bray, GA., Ryan, DH.[2018]

Citations

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

GSBR-1290 Obesity Topline Data Presentation GSBR-1290 Obesity Topline Results. Safety and Tolerability. Page 15. 15. GSBR-1290 Phase 2a Study Participant Disposition. Phase 2a Obesity Study (12 week). N= ...

2. 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 and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05762471

NCT05762471 | Phase 1b/2a Study of GSBR-1290 in Adult ... This study will evaluate safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects on GSBR-1290 in healthy overweight/obese ...

4. 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 ...

5. 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 The first patients have been dosed in the randomized, double-blind, placebo-controlled Phase 2b ACCESS clinical study evaluating GSBR-1290 in participants ...

6. ir.structuretx.com ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-provides-comprehensive-gsbr-1290-program

Press Release GSBR-1290 was generally well-tolerated with no treatment-related serious adverse events over 12 weeks; 2.8% study discontinuation rate due ...

7. sec.gov sec.gov/Archives/edgar/data/1888886/000110465923126639/tm2329572d16_ex99-1.htm

Structure Therapeutics Provides Comprehensive GSBR- ... The primary endpoint of the Phase 2a study is safety and tolerability of GSBR-1290. Key secondary endpoints include reduction in weight for both ...