DelfaGLP-1 Atlas

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UnknownPhase 1

A Study of Multiple-ascending Doses of GSBR-1290 in Healthy Overweight/Obese Participants

A 2-part, Phase 1, Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Comparative Bioavailability of Multiple-ascending Doses of GSBR-1290 in Healthy Overweight/Obese Participants

Asset

Aleniglipron / GSBR-1290

Oral · GLP-1 agonist

Listed sites

3

Recruiting sites

—

Enrollment

70

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI ≥27•Healthy volunteers

Primary endpoints

•Part 1•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))•Treatment-emergent AEs (any)

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 IDNCT06139055
Org study IDGSBR-1290-05

Timeline

Milestones

Study start2023-10-02actual
Study first posted2023-11-18actual
Last update posted2024-02-15actual
Primary completion2024-03estimated (month precision)
Study completion2024-03estimated (month precision)

Assets

Investigational agents

Aleniglipron / GSBR-1290

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Provided evidence of a signed informed consent before any study-related activities are initiated and be willing to comply with all study procedures.

2. Healthy overweight or obese adult men and women.

3. Age greater then or equal to (>=)18 and less than or equal to (<=) 75 years.

4. Body mass index (BMI) >=27.0 kilogram per square meter (kg/m^2).

Exclusion criteria

1. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease.

Endpoints (22)

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

22 endpoints
Primary/protocol endpoint

Part 1: 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:From start of study drug up to Day 10

Cmax

concentration, descriptive

Primary/protocol endpoint

Part 1: 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:From start of study drug up to Day 10

Tmax

descriptive

Primary/protocol endpoint/low confidence

Part 1: Analysis of Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters

Time frame:From start of study drug up to Day 10

concentration, descriptive

Primary/protocol endpoint

Part 1: Analysis of Area Under the Plasma Concentration-time Curve From 0 to infinity (AUC0-inf) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters

Time frame:From start of study drug up to Day 10

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Part 1: Analysis of Apparent Terminal Elimination Half-life (t1/2) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters

Time frame:From start of study drug up to Day 10

Half-life

descriptive

Primary/protocol endpoint

Part 1: Analysis of Total Apparent Body Clearance (CL/F) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters

Time frame:From start of study drug up to Day 10

descriptive

Primary/protocol endpoint

Part 1: Analysis of Apparent Volume of Distribution (Vz/F) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters

Time frame:From start of study drug up to Day 10

descriptive

Primary/protocol endpoint

Part 2: Number of Participants With Adverse Events (AEs) and Serious AEs

Time frame:From start of study drug up to End of study (EOS) in Part 2 (up to Day 98)

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Primary/protocol endpoint

Part 2: Number of Participants With Severity of AEs

Time frame:From start of study drug up to EOS in Part 2 (up to Day 98)

Treatment-emergent AEs (any)

descriptive

Primary/protocol endpoint

Part 2: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Time frame:From start of study drug up to EOS in Part 2 (up to Day 98)

descriptive

Primary/protocol endpoint

Part 2: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters

Time frame:From start of study drug up to EOS in Part 2 (up to Day 98)

change from baseline, event

Primary/protocol endpoint

Part 2: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters

Time frame:From start of study drug up to EOS in Part 2 (up to Day 98)

descriptive, event

Secondary/protocol endpoint

Part 1: Number of Participants With Adverse Events (AEs) and Serious AEs

Time frame:From start of study drug up to EOS in Part 1 (Day 17)

Serious AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Part 1: Number of Participants Based on Severity of AEs

Time frame:From start of study drug up to EOS in Part 1 (Day 17)

Treatment-emergent AEs (any)

descriptive

Secondary/protocol endpoint

Part 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Time frame:Baseline up to EOS in Part 1 (Day 17)

descriptive

Secondary/protocol endpoint

Part 1: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters

Time frame:Baseline up to EOS in Part 1 (Day 17)

change from baseline, event

Secondary/protocol endpoint

Part 1: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters

Time frame:Baseline up to EOS in Part 1 (Day 17)

descriptive

Secondary/protocol endpoint

Part 2: 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:From start of study drug up to Day 84

Cmax

concentration, descriptive

Secondary/protocol endpoint

Part 2: 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:From start of study drug up to Day 84

Tmax

descriptive

Secondary/protocol endpoint

Part 2: Analysis of Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (24 hours) at Steady State (AUC0-tau) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters

Time frame:From start of study drug up to Day 84

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Part 2: Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters

Time frame:From start of study drug up to Day 84

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Part 2: Analysis of Apparent Terminal Elimination Half-life (t1/2) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters

Time frame:From start of study drug up to Day 84

Half-life

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.