← Trials/Trial dossier/NCT05893043
A Study of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Participants
A Phase 1, Randomized, Double-blind, Placebo-controlled Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Volunteers
Asset
Aleniglipron / GSBR-1290
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
18
actual
Study population
Healthy volunteers
Key I/E criterion
—
Primary endpoints
•Serious AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))•Treatment-emergent AEs (any)•Vital Signs
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
For Cohort 1 only:
1. Japanese participants must have both parents and 4 grandparents of Japanese origin
For Cohort 2 only:
2. Non-Japanese participants must not have parents and grandparents of Japanese origin. Non-Japanese participants will be limited to Caucasians of European and Latin American descent or African Americans
For Cohorts 1 and 2:
3. Must have given written informed consent before any study-related activities are carried out
4. Adult males and females, age 18 to 55 years of age (inclusive) at screening
5. Body Mass Index (BMI) greater than or equal to (>=) 18.5 and less than or equal to (<=) 24.9 kilogram per square meter (kg/m^2), with a body weight (to 1 decimal place) >= 45.0 kg at screening
6. No nicotine use
7. Sitting blood pressure after resting for 5 minutes between 90 to 140 millimeter of mercury (mm Hg) systolic and 50 to 90 mm Hg diastolic and a heart rate between 40 to 100 beats per minute
8. Have suitable venous access for blood sampling
Exclusion criteria
1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or major surgery within the past 3 months
2. Liver function test results elevated > 2.0-fold the upper limit of normal (ULN) for gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), aspartate transaminase (AST) or alanine transaminase (ALT). Bilirubin above ULN
3. Estimated glomerular filtration rate (eGFR) < 60 milliliter per minute (mL/min)/1.73m^2 body surface area
4. Known hypersensitivity to any of the study drug ingredients
5. Any other condition or prior therapy that would make the participant unsuitable for this study
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
9 endpointsNumber of Participants With Adverse Events (AEs) and Serious AEs
Time frame:From start of study drug up to End of study (EOS) (up to Day 42)
Serious AEs (any)
event count, event
componentsTreatment-emergent AEs (any), Serious AEs (any)
Number of Participants Based on Severity of AEs
Time frame:From start of study drug up to EOS (up to Day 42)
Treatment-emergent AEs (any)
event count, event
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame:Baseline up to EOS (Day 42)
threshold achievement, event
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame:Baseline up to EOS (Day 42)
descriptive, event
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
Time frame:Baseline up to EOS (Day 42)
descriptive, event
Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters
Time frame:31 days
Cmax
concentration, descriptive
Analysis of Time to Maximum Observed Plasma Concentration (Tmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters
Time frame:31 days
Tmax
descriptive
Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters
Time frame:31 days
Plasma concentration (steady state)
concentration, descriptive
Analysis of Area Under the Plasma Concentration-time Curve (AUC) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters
Time frame:31 days
AUC₀–∞
concentration, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.