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CompletedPhase 1

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

NCT IDNCT05893043
Org study IDGSBR-1290-03

Timeline

Milestones

Study start2023-04-24actual
Study first posted2023-06-07actual
Primary completion2023-06-28actual
Study completion2023-06-28actual
Last update posted2023-07-14actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

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 endpoints
Primary/protocol endpoint

Number 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)

Primary/protocol endpoint

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

Primary/protocol endpoint

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Time frame:Baseline up to EOS (Day 42)

threshold achievement, event

Primary/protocol endpoint

Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters

Time frame:Baseline up to EOS (Day 42)

descriptive, event

Primary/protocol endpoint

Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters

Time frame:Baseline up to EOS (Day 42)

descriptive, event

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.