Clinical trial NCT06693843: 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
Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of GSBR-1290 in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity, Overweight, or Chronic Weight Management
Keywords: ACCESS, obesity, overweight, GSBR-1290, chronic weight management, obese, small molecule, GLP-1 receptor agonist, Structure Therapeutics
Lead sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-11-18
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percent change in body weight from Baseline to Week 36
timeFrame: Baseline and week 36
Secondary outcomes:
measure: Percentage of participants who achieve ≥5% reduction in body weight at Week 36
timeFrame: Baseline and week 36
measure: Percentage of participants who achieve ≥10% reduction in body weight at Week 36
timeFrame: Baseline and week 36
measure: Percentage of participants who achieve ≥15% reduction in body weight at Week 36
timeFrame: Baseline and week 36
measure: Change in body weight (absolute) from Baseline to Week 36
timeFrame: Baseline and week 36
measure: Change in waist circumference from Baseline to Week 36
timeFrame: Baseline and week 36
measure: Change in body mass index from Baseline to Week 36
timeFrame: Baseline and week 36
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: ACCESS Research Site
state: Arizona
city: Anaheim
country: United States
facility: ACCESS Research Site
state: California
city: Los Angeles
country: United States
facility: ACCESS Research Site
state: California
city: Montclair
country: United States
facility: ACCESS Research Site
state: California
city: Rancho Cucamonga
country: United States
facility: ACCESS Research Site
state: California
city: Sacramento
country: United States
facility: ACCESS Research Site
state: California
city: Spring Valley
country: United States
facility: ACCESS Research Site
state: California
city: Honolulu
country: United States
facility: ACCESS Research Site
state: Hawaii
city: Chicago
country: United States
facility: ACCESS Research Site
state: Illinois
city: Chicago
country: United States
facility: ACCESS Research Site
state: Illinois
city: Evanston
country: United States
facility: ACCESS Research Site
state: Illinois
city: Muncie
country: United States
facility: ACCESS Research Site
state: Indiana
city: Valparaiso
country: United States
facility: ACCESS Research Site
state: Indiana
city: West Des Moines
country: United States
facility: ACCESS Research Site
state: Iowa
city: Baton Rouge
country: United States
facility: ACCESS Research Site
state: Louisiana
city: Richfield
country: United States
facility: ACCESS Research Site
state: Minnesota
city: Hazelwood
country: United States
facility: ACCESS Research Site
state: Missouri
city: Saint Peters
country: United States
facility: ACCESS Research Site
state: Missouri
city: Springfield
country: United States
facility: ACCESS Research Site
state: Missouri
city: Albany
country: United States
facility: ACCESS Research Site
state: New York
city: Binghamton
country: United States
facility: ACCESS Research Site
state: New York
city: Brooklyn
country: United States
facility: ACCESS Research Site
state: New York
city: Rochester
country: United States
facility: ACCESS Research Site
state: New York
city: Wilmington
country: United States
facility: ACCESS Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: ACCESS Research Site
state: Ohio
city: Norman
country: United States
facility: ACCESS Research Site
state: Oklahoma
city: Medford
country: United States
facility: ACCESS Research Site
state: Oregon
city: Pittsburgh
country: United States
facility: ACCESS Research Site
state: Pennsylvania
city: Moncks Corner
country: United States
facility: ACCESS Research Site
state: South Carolina
city: Chattanooga
country: United States
facility: ACCESS Research Site
state: Tennessee
city: Austin
country: United States
facility: ACCESS Research Site
state: Texas
city: Austin
country: United States
facility: ACCESS Research Site
state: Texas
city: Dallas
country: United States
facility: ACCESS Research Site
state: Texas
city: Dallas
country: United States
facility: ACCESS Research Site
state: Texas
city: Mesquite
country: United States
facility: ACCESS Research Site
state: Texas
city: Shavano Park
country: United States
facility: ACCESS Research Site
state: Texas
city: West Jordan
country: United States
facility: ACCESS Research Site
state: Utah
city: Winchester
country: United States
facility: ACCESS Research Site
state: Virginia
city: Morgantown
country: United States
facility: ACCESS Research Site
state: West Virginia
Study officials:
References: