Clinical trial NCT06703021: A Dose-Range Study of GSBR-1290 in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Efficacy of Increasing Optimal 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 (ACCESS II)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity
Overweight
Chronic Weight Management
Keywords: ACCESS II
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: 2024-11-25
Enrollment: 82
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: 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: 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

Primary outcomes:
measure: Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
timeFrame: Baseline and week 36
measure: Adverse events of special interest
timeFrame: Baseline and week 36
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters, including hematology, plasma chemistry, coagulation, and urinalysis
timeFrame: Baseline and week 36
measure: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to : heart rate and QRS duration
timeFrame: Baseline and week 36
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, including systolic and diastolic Blood Pressure, Heart Rate, Respiratory Rate, and temperature
timeFrame: Baseline and week 36
Secondary outcomes:
measure: Area Under the Plasma Concentration-time Curve From Time 0 to Tau (AUC0-tau)
timeFrame: Baseline and week 36
measure: Maximum Observed Plasma Concentration (Cmax) of GSBR-1290
timeFrame: Baseline and week 36
measure: Trough Concentrations (Ctrough) of GSBR-1290
timeFrame: Baseline and week 36
measure: Time of Maximum Observed Plasma Concentration (Tmax) of GSBR-1290
timeFrame: Baseline and week 36
measure: Terminal Elimination Half-life (t1/2) for GSBR-1290
timeFrame: Baseline and week 36
Other outcomes:
measure: Percent change in body weight
timeFrame: Baseline and week 36
measure: Change in body weight (absolute)
timeFrame: Baseline and week 36
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 waist circumference
timeFrame: Baseline and week 36
measure: Change in body mass index
timeFrame: Baseline and week 36
measure: Change in patient-reported outcomes (hunger and satiety questionnaire)
timeFrame: Baseline and week 36
measure: Change in HDL and LDL cholesterol
timeFrame: Baseline and week 36
Locations:
city: Glendale
country: United States
facility: ACCESS II Research Site
state: California
city: Montclair
country: United States
facility: ACESS II Research Site
state: California
city: Valparaiso
country: United States
facility: ACESS II Research Site
state: Indiana
city: West Des Moines
country: United States
facility: ACCESS II Research Site
state: Iowa
city: Medford
country: United States
facility: ACESS II Research Site
state: Oregon
city: East Greenwich
country: United States
facility: ACCESS II Research Site
state: Rhode Island
city: North Charleston
country: United States
facility: ACCESS II Research Site
state: South Carolina
city: Dallas
country: United States
facility: ACCESS II Research Site
state: Texas
city: San Antonio
country: United States
facility: ACCESS II Research Site
state: Texas
city: West Jordan
country: United States
facility: ACESS II Research Site
state: Utah
Study officials:
References: