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CompletedPhase 1, PHASE2

Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus

A Phase 1b/2a, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus on Metformin

Asset

Aleniglipron / GSBR-1290

Oral · GLP-1 agonist

Listed sites

4

Recruiting sites

Enrollment

142

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI 27-40HbA1c 7-10.5%

Primary endpoint

Serious AEs (any) (Treatment-emergent AEs (any), Serious 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 IDNCT05762471
Org study IDGSBR-1290-02

Timeline

Milestones

Study start2023-01-09actual
Study first posted2023-03-09actual
Primary completion2024-04-11actual
Study completion2024-04-11actual
Last update posted2024-04-25actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

cohorts 1-4:

1. Provided evidence of a signed consent

2. Age ≥ 18 and ≤ 75 years

3. Healthy overweight/obese adult men and women with body mass index ≥ 27 and ≤ 40 kg/m2

4. No nicotine use

5. Have a suitable venous access for blood sampling

Inclusion Criteria cohort 5:

1. Men and women with T2DM of ≥6 months duration

2. Age ≥ 18 and ≤ 75 years

3. BMI ≥ 27 and ≤ 40 kg/m2

4. Treated with stable doses of ≥500 mg of metformin with a duration ≥6 months and at stable doses for ≥2 months with a screening HbA1c ≥7.0% and ≤10.5%.

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 major 3 months

2. A sitting BP after resting for 5 minutes > 160mm Hg systolic or > 100 mm Hg diastolic or an apical pulse rate <50 or >100 beats per minute.

3. Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval

4. Liver function test results elevated > 2.0-fold above the ULN for gamma glutamyl transferase, alkaline phosphatase, aspartate aminotransferase or alanine aminotransferase. Bilirubin above the ULN

5. Estimated glomerular filtration rate < 60mL/min/1.73 m2 body surface area

6. Known hypersensitivity to any of the study drug ingredients

7. Any other condition or prior therapy that would make the participant unsuitable for this study

Endpoints (5)

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

5 endpoints
Primary/protocol endpoint

Incidence, severity and relationship of AE/SAE, vital signs, laboratory measures and ECG to assess safety and tolerability of multiple oral doses of GSBR-1290 in HOV and T2DM

Time frame:42 days

Serious AEs (any)

descriptive

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

Secondary/protocol endpoint

Analysis of Cmax at specified timepoints predose and postdose to calculate PK parameters

Time frame:31 days

Cmax

concentration, descriptive

Secondary/protocol endpoint

Analysis of Tmax at specified timepoints predose and postdose to calculate PK parameters

Time frame:31 days

Tmax

descriptive

Secondary/protocol endpoint

Analysis of AUC at specified timepoints predose and postdose to calculate PK parameters

Time frame:31 days

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Identification of GSBR-1290 metabolites following oral administration of multiple doses in plasma

Time frame:31 days

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.