A Dose-Range Study of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity
Phase 2
Active, not recruiting
- Conditions
- ObesityOverweightChronic Weight Management
- Interventions
- Drug: aleniglipron or placebo
- Registration Number
- NCT06703021
- Lead Sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
- Brief Summary
Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (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 44-week period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 82
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sentinel aleniglipron or placebo Participants will receive aleniglipron or placebo administered orally. Cohort 1a aleniglipron or placebo Participants will receive aleniglipron or placebo administered orally. Cohort 1b aleniglipron or placebo Participants will receive aleniglipron or placebo administered orally. Cohort 1c aleniglipron or placebo Participants will receive aleniglipron or placebo administered orally.
- Primary Outcome Measures
Name Time Method Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) Baseline and week 44 Adverse events of special interest Baseline and week 44 Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters, including hematology, plasma chemistry, coagulation, and urinalysis Baseline and week 44 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 Baseline and week 44 Number of Participants With Clinically Significant Change From Baseline in Vital Signs, including systolic and diastolic Blood Pressure, Heart Rate, Respiratory Rate, and temperature Baseline and week 44
- Secondary Outcome Measures
Name Time Method Area Under the Plasma Concentration-time Curve From Time 0 to Tau (AUC0-tau) Baseline and week 44 Maximum Observed Plasma Concentration (Cmax) of aleniglipron Baseline and week 44 Trough Concentrations (Ctrough) of aleniglipron Baseline and week 44 Time of Maximum Observed Plasma Concentration (Tmax) of aleniglipron Baseline and week 44 Terminal Elimination Half-life (t1/2) for aleniglipron Baseline and week 44
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie GSBR-1290's efficacy in obesity-related comorbidities as studied in NCT06703021?
How does GSBR-1290 compare to GLP-1 receptor agonists in weight management for patients with metabolic syndrome?
Which biomarkers correlate with response to GSBR-1290 in Phase 2 trials for obesity with cardiovascular comorbidities?
What adverse event profiles are reported for GSBR-1290 versus placebo in Gasherbrum Bio's Phase 2 obesity study?
What combination therapies or competitor drugs show synergistic effects with GSBR-1290 in chronic weight management?
Trial Locations
- Locations (1)
ACCESS II Research Site
🇺🇸West Jordan, Utah, United States
ACCESS II Research Site🇺🇸West Jordan, Utah, United States