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A Phase 2b, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of GSBR-1290 in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity (ACCESS)

G

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

Status and phase

Active, not recruiting
Phase 2

Conditions

Obesity, Overweight, or Chronic Weight Management

Treatments

Drug: GSBR-1290 or Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06693843
GSBR-1290-06

Details and patient eligibility

About

This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses of GSBR-1290 in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to GSBR-1290 or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of GSBR-1290 or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment.

Enrollment

220 estimated patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signed informed consent
  • BMI ≥30 kg/m2 or BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesity related comorbidity

Exclusion criteria

  • Previous documented diagnosis of diabetes mellitus.
  • Self-reported change in body weight >5% within 3 months before Screening
  • Body weight ≤80 kg at Screening
  • Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

220 participants in 3 patient groups

Cohort 1
Experimental group
Description:
Participants will receive GSBR-1290 or Placebo administered orally.
Treatment:
Drug: GSBR-1290 or Placebo
Drug: GSBR-1290 or Placebo
Drug: GSBR-1290 or Placebo
Cohort 2
Experimental group
Description:
Participants will receive GSBR-1290 or Placebo administered orally.
Treatment:
Drug: GSBR-1290 or Placebo
Drug: GSBR-1290 or Placebo
Drug: GSBR-1290 or Placebo
Cohort 3
Experimental group
Description:
Participants will receive GSBR-1290 or Placebo administered orally.
Treatment:
Drug: GSBR-1290 or Placebo
Drug: GSBR-1290 or Placebo
Drug: GSBR-1290 or Placebo

Trial contacts and locations

39

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Central trial contact

Medical Director

Data sourced from clinicaltrials.gov

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