A Dose-Range Study of GSBR-1290 in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity (ACCESS II)

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

Status and phase: Active, not recruiting; Phase 2

Conditions: Overweight; Obesity; Chronic Weight Management

Treatments: Drug: GSBR-1290 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06703021

GSBR-1290-09

Details and patient eligibility

About

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.

Enrollment: 82 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
• Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
• Use of medications intended to promote weight loss, within 6 months prior to Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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82 participants in 4 patient groups

Sentinel

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

Drug: GSBR-1290 or Placebo

Cohort 1a

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

Drug: GSBR-1290 or Placebo

Cohort 1b

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

Drug: GSBR-1290 or Placebo

Cohort 1c

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

Drug: GSBR-1290 or Placebo