GSBR-1290 for Obesity

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Gasherbrum Bio, Inc

No Placebo Group

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.

Research Team

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.

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Exclusion Criteria

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

Treatment Details

Interventions

GSBR-1290 (Other)

Trial OverviewThe 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

5Treatment groups

Experimental Treatment

Group I: Part 2 (Cohort 3): GSBR-1290/Placebo Tablet and GSBR-1290/Placebo CapsuleExperimental Treatment2 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 TabletExperimental Treatment2 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 TabletExperimental Treatment2 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 CapsuleExperimental Treatment1 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 TabletExperimental Treatment1 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).