GSBR-1290 for Obesity (ACCESS II Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various GSBR-1290 dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 36-week period.

Eligibility Criteria

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

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 haven't taken weight loss drugs in the last 6 months.

Treatment Details

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.

4Treatment groups

Experimental Treatment

Group I: SentinelExperimental Treatment1 Intervention

Participants will receive GSBR-1290 or Placebo administered orally.

Group II: Cohort 1cExperimental Treatment1 Intervention

Participants will receive GSBR-1290 or Placebo administered orally.

Group III: Cohort 1bExperimental Treatment1 Intervention

Participants will receive GSBR-1290 or Placebo administered orally.

Group IV: Cohort 1aExperimental Treatment1 Intervention

Participants will receive GSBR-1290 or Placebo administered orally.