Aleniglipron for Liver Disease

Not yet recruiting at 1 trial location
MD
Overseen ByMedical Director
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the drug aleniglipron works in people with liver problems. Researchers seek to determine the best dose for these patients by studying how the body processes the drug. Participants will take aleniglipron orally, and the trial will consist of two parts testing this method. It suits adults with liver issues who understand the trial process and can follow instructions. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that aleniglipron is likely to be safe for humans?

Research has shown that aleniglipron is generally safe, based on data from over 625 people in various studies. Notably, no reports have indicated liver damage caused by the drug, which is crucial since the current trial focuses on liver disease. Although some participants stopped taking the treatment due to side effects, this accounted for only about 10.4% of participants. Overall, aleniglipron is usually well-tolerated and as safe as similar treatments.12345

Why do researchers think this study treatment might be promising?

Unlike the usual treatments for liver disease, which often focus on managing symptoms or slowing disease progression, Aleniglipron brings something new to the table. Researchers are excited about Aleniglipron because it is designed to be administered orally, which could improve patient convenience and adherence compared to more invasive treatments like injections. The drug works through a novel mechanism that directly targets pathways in the liver, potentially offering more effective and direct treatment of the disease itself. This innovative approach could provide significant advantages over current options, making it an exciting development in the field.

What evidence suggests that aleniglipron might be an effective treatment for liver disease?

Research has shown that aleniglipron, a pill that activates certain receptors in the body, yields promising results for weight loss. Participants lost up to 16.3% of their weight compared to those taking a placebo. On average, individuals lost between 13.6% and 15.3% of their weight over 44 weeks. Importantly, studies reported no serious liver problems, suggesting it is likely safe for the liver. While aleniglipron is primarily known for aiding weight loss, it might also improve liver health by reducing fat and inflammation. Participants in this trial will receive aleniglipron orally to evaluate its effects on liver disease.678910

Are You a Good Fit for This Trial?

This trial is for adults who have liver disease with varying levels of liver function. Participants should not have other serious health conditions that could interfere with the study, and must meet specific medical requirements set by the researchers.

Inclusion Criteria

Is a continuous non-smoker or smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing and agrees to maintain the same smoking status from screening until after the last PK sample collection
I am following the required birth control guidelines for this study.
I am between 18 and 85 years old.
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Exclusion Criteria

I am pregnant or currently breastfeeding.
History or presence of alcohol or drug abuse (including symptoms of cannabis disorder) within the past 6 months prior to dosing
History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of aleniglipron administered orally

1 day

Follow-up

Participants are monitored for safety and pharmacokinetics after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aleniglipron

Trial Overview

The study is testing how the body processes a drug called aleniglipron in people with different degrees of liver impairment to help determine safe dosing guidelines.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Participants will receive aleniglipron administered orally Part 2Experimental Treatment1 Intervention
Group II: Participants will receive aleniglipron administered orally Part 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials
5
Recruited
530+

Citations

Structure's GLP-1 Aleniglipron Set For Phase III With Solid ...

The oral GLP-1 showed efficacy on par with Lilly's orforglipron, positioning it as a contender in the red-hot obesity drug market.

44-week data bolster best-in-class case for Structure's ...

Oral GLP-1R agonist aleniglipron delivers up to 16.3% placebo-adjusted weight loss and will advance to Phase III. By Lindsay Martin, Biopharma ...

A Dose-Range Study of Aleniglipron (GSBR-1290) in ...

Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (GSBR-1290) dose ...

Orforglipron Results: How Much Weight Can You Lose?

Orforglipron produced up to approximately 9 72 weeks in the SURMOUNT-1 trial. So in raw efficacy terms, orforglipron at 9% weight loss over 40 ...

Structure's Aleniglipron: Study Results, Oral GLP-1 ...

Recent data reported up to 16.3% placebo-adjusted weight reduction and roughly 13.6% to 15.3% mean reduction across active groups at 44 weeks.

Press Release

Aleniglipron demonstrated a compelling safety profile in more than 625 participants across all studies. Importantly, to date, there have been no ...

Oral small molecule GLP-1 receptor agonist aleniglipron in ...

Treatment-related discontinuations were 10.4% across aleniglipron arms, with no events of drug-induced liver injury. No drug-induced liver ...

Untitled

Aleniglipron demonstrated a compelling safety profile across all studies. Importantly, there were no cases of drug-induced liver injury, no ...

Aleniglipron Shows Positive Phase 2 ACCESS II Results in ...

Data show that aleniglipron maintains a tolerability profile consistent with the GLP‐1 receptor agonist class, with a strong safety profile and ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/42338042/

A Pooled Analysis of the Orforglipron Phase 3 Clinical Trials

orforglipron treatment was not associated with drug-induced liver injury, demonstrating a hepatic safety profile similar to placebo or active comparators.