GSBR-1290 for Obesity

Recruiting at 2 trial locations

Overseen By Clinical Operations Lead

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Gasherbrum Bio, Inc

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: 2

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new medication called GSBR-1290 in tablet and capsule forms on healthy overweight/obese individuals. It aims to see how the body processes the drug and compares the effectiveness of different forms.

Do I have to stop taking my current medications for the GSBR-1290 trial?

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.

Eligibility Criteria

This clinical trial is for healthy adult men and women who are overweight or obese, aged between 18 to 75 years old with a BMI of at least 27.0 kg/m^2. Participants must understand the study procedures and agree to follow them by signing an informed consent form.

Inclusion Criteria

I am between 18 and 75 years old.

Body mass index (BMI) greater than or equal to 27.0 kilogram per square meter (kg/m^2).

Provided evidence of a signed informed consent before any study-related activities are initiated and be willing to comply with all study procedures.

Exclusion Criteria

I have a significant health condition affecting my heart, lungs, liver, kidneys, blood, stomach, hormones, immune system, skin, or nerves.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive a single dose of GSBR-1290 oral capsule or tablet in a crossover design

2 weeks

2 visits (in-person)

Treatment Part 2

Participants receive GSBR-1290 or placebo tablets once daily for 12 weeks, with further randomization in the last 4 weeks

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GSBR-1290

Trial Overview The trial is testing GSBR-1290, a new medication in capsule/tablet form, against a placebo (a pill with no active drug) to assess its safety and how it's processed by the body when given repeatedly to healthy overweight/obese individuals.

Participant Groups

Group I: Part 2 (Cohort 3): GSBR-1290/Placebo Tablet and GSBR-1290/Placebo Capsule Experimental Treatment 2 Interventions

Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks. In the last 4 weeks, participants will be further randomized to GSBR-1290 capsules or tablets or matching-placebo at Week 9 to 10 followed by alternate (capsule or tablet) formulation of either GSBR-1290 or placebo at Week 11 to 12.

Group II: Part 2 (Cohort 2): GSBR-1290/Placebo Tablet Experimental Treatment 2 Interventions

Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks.

Group III: Part 2 (Cohort 1): GSBR-1290/Placebo Tablet Experimental Treatment 2 Interventions

Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks.

Group IV: Part 1(Sequence 2: Tablet to Capsule): GSBR-1290 Tablet/GSBR-1290 Capsule Experimental Treatment 1 Intervention

Participants will receive a single dose of GSBR-1290 oral tablet formulation on Day 1 in Treatment Period 1 followed by GSBR-1290 oral capsule formulation on Day 8 (Day 1 of Treatment Period 2).

Group V: Part 1 (Sequence 1: Capsule to Tablet): GSBR-1290 Capsule/GSBR-1290 Tablet Experimental Treatment 1 Intervention

Participants will receive a single dose of GSBR-1290 oral capsule formulation on Day 1 in Treatment Period 1 followed by GSBR-1290 oral tablet formulation on Day 8 (Day 1 of Treatment Period 2).

Who Is Running the Clinical Trial?

Gasherbrum Bio, Inc

Lead Sponsor

Trials

3

Recruited

230+

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

Lead Sponsor

Trials

5

Recruited

530+