GSBR-1290

Active not recruitingPhase 2

Aleniglipron Phase 2 in Type 2 Diabetes Mellitus

A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety and Tolerability of Aleniglipron in Adult Participants With Type 2 Diabetes Mellitus Living With Obesity or Overweight

Lead sponsor

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Asset

Aleniglipron / GSBR-1290

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c 6.5-10%

Primary endpoints

•Serious AEs (any)•Assessment of vital signs (Systolic BP, change, Diastolic BP, change, Heart rate, change)•Assessment of laboratory measures

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 IDNCT07400588

Org study IDGSBR-1290-17

Timeline

Milestones

Study start2025-12-01actual

Study first posted2026-02-10actual

Last update posted2026-04-27actual

Primary completion2026-09estimated (month precision)

Study completion2026-09estimated (month precision)

Assets

Investigational agents

Aleniglipron / GSBR-1290

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age79 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Signed Informed Consent

•A diagnosis of T2DM of ≥6 months,

•Hemoglobin A1c (HbA1c) ≥6.5% to ≤10% at Screening

•Have a BMI ≥27.0 kg/m2

Exclusion criteria

•Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. All participants must have a photo fundoscopy, optical coherence tomography, or slit lamp assessment prior to randomization and within the last 12 months to confirm the absence or stable status of diabetic retinopathy and/or macular edema.

•Present or planned use of any drug that could interfere with glucose levels

•Self-reported change in body weight >5 kg (11 pounds) within 3 months before screening

•Have prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to Screening)

•Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to Screening, including, but not limited to, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal endoluminal liner

Endpoints (12)

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.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

Glycemic / diabetes

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Absolute change in body weight from Baseline

Time frame:Baseline to week 31

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent change in body weight from Baseline

Time frame:Baseline to week 31

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in HbA1c from Baseline

Time frame:Baseline to week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose from Baseline

Time frame:Baseline to week 31

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

Incidence, severity and relationship of AEs/SAEs

Time frame:Baseline to week 31

Serious AEs (any)

descriptive

Primary/protocol endpoint

Assessment of vital signs

Time frame:Baseline to week 31

change from baseline, event

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Primary/protocol endpoint

Assessment of laboratory measures

Time frame:Baseline to week 31

threshold achievement, event

Primary/protocol endpoint

Assessment of Electrocardiograms (ECG)

Time frame:Baseline to week 31

threshold achievement, event

Secondary/protocol endpoint

PK parameters including but not limited to AUC

Time frame:Baseline to week 30

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PK parameters including but not limited to Cmax

Time frame:Baseline to week 30

Cmax

concentration, descriptive

Secondary/protocol endpoint

PK parameters including but not limited to Tmax

Time frame:Baseline to week 30

Tmax

descriptive

Secondary/protocol endpoint

PK parameters including but not limited to Ctrough

Time frame:Baseline to week 30

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.