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Not yet recruitingPhase 1

Aleniglipron Hepatic Impairment Study

A Phase 1, Single-Dose, Open-Label Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on Aleniglipron Pharmacokinetics

Asset

Aleniglipron / GSBR-1290

Oral · GLP-1 agonist

Listed sites

2

Recruiting sites

-

Estimated enrollment

36

Study population

Hepatic impairment

Eligibility highlights

•BMI 17-40

Primary endpoint

•PK parameters

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07872033
Org study IDGSBR-1290-20

Timeline

Milestones

Study first posted2026-10-13actual
Last update posted2026-10-21actual
Study start2026-10estimated (month precision)
Primary completion2027-08estimated (month precision)
Study completion2027-12estimated (month precision)

Assets

Investigational agents

Who this study enrolls

Hepatic impairment

Who can enroll

Minimum age18 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Is an adult, male or female, ≥ 18 to 85 years of age (inclusive), at screening.

2. Female and male participants must follow protocol-specified contraception guidance as described in Section 5.4.2.1 and Section 5.4.2.2.

3. Is a continuous non-smoker or smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing. Participants must agree to maintain the same smoking status (i.e., smoker or non-smoker) from screening and until after the last PK sample collection.

4. BMI ≥ 17.0 and ≤ 40.0 kg/m2 and weight of at least 40.0 kg at screening.

5. Understands the study procedures in the ICF and be willing and able to comply with the protocol and communicate effectively with study personnel.

Exclusion criteria

1. Is mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the conduct of the study.

2. History or presence of alcohol or drug abuse (including participants with symptoms of cannabis disorder) within the past 6 months prior to the dosing.

3. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.

4. Female participant with a positive serum pregnancy test at screening or at check-in or who is lactating or breastfeeding.

5. Has positive drug results at screening or at check-in, unless the positive drug screen is due to prescription drug use that is approved by the PI or designee. Participants with a positive result for cannabinoids may be enrolled at the discretion of the PI or designee and the Sponsor.

6. Has taken medications intended to promote weight loss within 3 months or 5 half-lives, whichever is longer, prior to screening, including, but not limited to GLP-1 RAs.

Endpoints (6)

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

6 endpoints
Primary/protocol endpoint

PK parameters including but not limited to AUC0-t

Time frame:Baseline to Day 5 (Part 1)

descriptive

Primary/protocol endpoint

PK parameters including but not limited to AUC0-inf

Time frame:Baseline to Day 5 (Part 1)

descriptive

Primary/protocol endpoint

PK parameters including but not limited to Cmax

Time frame:Baseline to Day 5 (Part 1)

concentration, descriptive

Primary/protocol endpoint

PK parameters including but not limited to AUC0-t

Time frame:Baseline to Day 5 (Part 2)

descriptive

Primary/protocol endpoint

PK parameters including but not limited to AUC0-inf

Time frame:Baseline to Day 5 (Part 2)

descriptive

Primary/protocol endpoint

PK parameters including but not limited to Cmax

Time frame:Baseline to Day 5 (Part 2)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 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 November 5, 2026 snapshot.