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
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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 endpointsPK parameters including but not limited to AUC0-t
Time frame:Baseline to Day 5 (Part 1)
descriptive
PK parameters including but not limited to AUC0-inf
Time frame:Baseline to Day 5 (Part 1)
descriptive
PK parameters including but not limited to Cmax
Time frame:Baseline to Day 5 (Part 1)
concentration, descriptive
PK parameters including but not limited to AUC0-t
Time frame:Baseline to Day 5 (Part 2)
descriptive
PK parameters including but not limited to AUC0-inf
Time frame:Baseline to Day 5 (Part 2)
descriptive
PK parameters including but not limited to Cmax
Time frame:Baseline to Day 5 (Part 2)
concentration, descriptive
Provenance
Sources
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.