Hepatic ImpairmentPhase 1NCT07872033
Aleniglipron Hepatic Impairment Study
A Phase 1 study testing Aleniglipron in people with Hepatic Impairment, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the PK of aleniglipron in participants with Hepatic Impairment to establish scientifically guided dosing recommendations in these special patient populations. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Aleniglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is an adult, male or female, ≥ 18 to 85 years of age (inclusive), at screening.
- Female and male participants must follow protocol-specified contraception guidance as described in Section 5.4.2.1 and Section 5.4.2.2.
- 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.
- BMI ≥ 17.0 and ≤ 40.0 kg/m2 and weight of at least 40.0 kg at screening.
- Understands the study procedures in the ICF and be willing and able to comply with the protocol and communicate effectively with study personnel.
Who cannot join
- Is mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the conduct of the study.
- History or presence of alcohol or drug abuse (including participants with symptoms of cannabis disorder) within the past 6 months prior to the dosing.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- Female participant with a positive serum pregnancy test at screening or at check-in or who is lactating or breastfeeding.
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Research Site
Orlando, Florida, 32809
Medical Director, 650-457-1959, GSBRClinicalTrials@Structuretx.com
Research Site
San Antonio, Texas, 78215
Medical Director, 650-457-1959, GSBRClinicalTrials@Structuretx.com
About this study
Official title: A Phase 1, Single-Dose, Open-Label Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on Aleniglipron Pharmacokinetics
The purpose of this study is to evaluate the PK of aleniglipron in participants with Hepatic Impairment to establish scientifically guided dosing recommendations in these special patient populations.
- Conditions
- Hepatic Impairment
- Being tested
- Aleniglipron
- Keywords
- Hepatic Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AleniglipronDrug
administered orally
| Study group | Role | What they receive |
|---|---|---|
| Participants will receive aleniglipron administered orally Part 1 | Experimental | Aleniglipron administered orally. Receives: Drug: Aleniglipron |
| Participants will receive aleniglipron administered orally Part 2 | Experimental | Aleniglipron administered orally. Receives: Drug: Aleniglipron |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters including but not limited to AUC0-t
Measured: Baseline to Day 5 (Part 1)
PK parameters including but not limited to AUC0-inf
Measured: Baseline to Day 5 (Part 1)
PK parameters including but not limited to Cmax
Measured: Baseline to Day 5 (Part 1)
PK parameters including but not limited to AUC0-t
Measured: Baseline to Day 5 (Part 2)
PK parameters including but not limited to AUC0-inf
Measured: Baseline to Day 5 (Part 2)
PK parameters including but not limited to Cmax
Measured: Baseline to Day 5 (Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872033
- Sponsor's protocol ID
- GSBR-1290-20
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose, Open-Label Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on Aleniglipron Pharmacokinetics
- ClinicalTrials.gov ID
- NCT07872033
- Acronym / sponsor ID
- GSBR-1290-20
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the PK of aleniglipron in participants with Hepatic Impairment to establish scientifically guided dosing recommendations in these special patient populations.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants will receive aleniglipron administered orally Part 1 | Experimental | Drug: AleniglipronAleniglipron administered orally. |
| Participants will receive aleniglipron administered orally Part 2 | Experimental | Drug: AleniglipronAleniglipron administered orally. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is an adult, male or female, ≥ 18 to 85 years of age (inclusive), at screening.
- Female and male participants must follow protocol-specified contraception guidance as described in Section 5.4.2.1 and Section 5.4.2.2.
- 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.
- BMI ≥ 17.0 and ≤ 40.0 kg/m2 and weight of at least 40.0 kg at screening.
- Understands the study procedures in the ICF and be willing and able to comply with the protocol and communicate effectively with study personnel.
Key exclusion criteria (6 listed)
- Is mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the conduct of the study.
- History or presence of alcohol or drug abuse (including participants with symptoms of cannabis disorder) within the past 6 months prior to the dosing.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- Female participant with a positive serum pregnancy test at screening or at check-in or who is lactating or breastfeeding.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aleniglipronadministered orally | Drug | Participants will receive aleniglipron administered orally Part 1, Participants will receive aleniglipron administered orally Part 2 |
Primary outcome
PK parameters including but not limited to AUC0-t
Time frame: Baseline to Day 5 (Part 1)
PK parameters including but not limited to AUC0-inf
Time frame: Baseline to Day 5 (Part 1)
PK parameters including but not limited to Cmax
Time frame: Baseline to Day 5 (Part 1)
PK parameters including but not limited to AUC0-t
Time frame: Baseline to Day 5 (Part 2)
PK parameters including but not limited to AUC0-inf
Time frame: Baseline to Day 5 (Part 2)
PK parameters including but not limited to Cmax
Time frame: Baseline to Day 5 (Part 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aleniglipron in people with Hepatic Impairment, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director (650-457-1959, GSBRClinicalTrials@Structuretx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK parameters including but not limited to AUC0-t (time frame: Baseline to Day 5 (Part 1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.