GSBR-1290 for Obesity and Type 2 Diabetes

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

142 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, GSBR-1290, in overweight/obese people and those with Type 2 Diabetes on Metformin. It aims to see if the drug is safe and how it affects the body, including its impact on blood sugar and weight.

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.

What data supports the effectiveness of the drug GSBR-1290 for obesity and type 2 diabetes?

The research on orlistat, a drug used for obesity and type 2 diabetes, shows that it can lead to modest weight loss and improve blood sugar control in patients with type 2 diabetes. This suggests that similar drugs, like GSBR-1290, might also be effective in managing these conditions. ^{1 2 3 4 5}

How is the drug GSBR-1290 different from other drugs for obesity and type 2 diabetes?

The drug GSBR-1290 is unique because it is being specifically investigated for its effects on both obesity and type 2 diabetes, whereas existing drugs like orlistat and sibutramine have been primarily used for weight loss with secondary benefits for diabetes. This trial may offer new insights into a treatment that directly targets both conditions simultaneously. ^{1 2 4 5 6}

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Drug treatment of obesity and type 2 diabetes]. [2006]

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

Orlistat in the treatment of obesity. [2019]

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

Combination Therapies for Obesity. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Effects of 1-year orlistat treatment compared to placebo on insulin resistance parameters in patients with type 2 diabetes. [2018]

5. France pubmed.ncbi.nlm.nih.gov

New antiobesity agents in type 2 diabetes: overview of clinical trials with sibutramine and orlistat. [2018]

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

Drug treatment of the overweight patient. [2018]