28 Participants NeededMy employer runs this trial

AZD6234 + AZD9550 for Liver Disease

Recruiting at 3 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
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 test the safety of two new treatments, AZD6234 and AZD9550, for individuals with liver disease and those with normal liver function. Researchers seek to understand how these treatments affect people with varying levels of liver impairment. The trial suits those with stable liver disease for at least six months or those with healthy liver function. As a Phase 1 trial, participants will be among the first to receive these new treatments, aiding researchers in understanding their effects in humans.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you must stop all current medications, but it does mention that healthy controls should avoid using prescription or non-prescription drugs and supplements shortly before the trial. For those with liver issues, certain medications like weight loss drugs and some diabetes treatments are not allowed. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is investigating the safety of AZD6234 and AZD9550 for individuals with liver problems. These drugs are administered as single injections under the skin. Early results indicate they are generally well-tolerated. In these studies, researchers monitor for any side effects or reactions from using these drugs together.

As this is an early phase of the study, researchers are still gathering basic safety information. This phase typically involves a smaller group of participants to ensure the treatment does not cause serious harm. So far, no severe side effects have been reported, but researchers continue to monitor safety as the study progresses.

These drugs are not yet approved for any condition, but ongoing research is crucial to ensure their safety for wider use in future treatments.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about AZD6234 and AZD9550 for liver disease because they offer a fresh approach compared to current treatments like lifestyle changes, medications such as ursodeoxycholic acid, and liver transplants. Unlike traditional therapies that mainly focus on managing symptoms or slowing disease progression, AZD6234 and AZD9550 potentially target the underlying mechanisms of liver impairment. This could mean a more direct method of addressing liver dysfunction. Additionally, these drugs might offer new hope for patients with varying degrees of liver impairment, providing a tailored approach to treatment based on the severity of the condition.

What evidence suggests that this trial's treatments could be effective for liver disease?

Research has shown that AZD6234 and AZD9550 are under investigation for their potential to treat liver issues such as Non-alcoholic Steatohepatitis (NASH). In this trial, participants will receive either AZD6234 or AZD9550. Early studies suggested that AZD9550 might aid liver disease by targeting specific processes involved in fat buildup and liver inflammation. This could particularly benefit individuals with NASH, a liver condition often found in those who are overweight. Although research is ongoing, these treatments show promise in reducing inflammation and improving liver function. As studies progress, scientists aim to better understand how these treatments work individually and assess their effectiveness.13456

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85, either healthy or with stable, chronic liver disease (Child Pugh B or C). Participants must weigh at least 50 kg and have a BMI between 18-42. People with well-controlled type 2 diabetes can join. Women of childbearing age and men must use contraception.

Inclusion Criteria

4. T2DM allowed if HbA1c \<10% and no severe hypo/hyperglycaemia or hospitalisation within 6 months.
My body weight is at least 50 kg and my BMI is between 18 and 42.
I follow birth control rules and, if female, have a negative pregnancy test.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive a single SC dose of AZD9550

1 day
1 visit (in-person)

Washout

Washout period to minimize impact from AZD9550 before administering AZD6234

2-4 weeks

Treatment Period 2

Participants receive a single SC dose of AZD6234

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and PK parameters

8 weeks
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • AZD6234
  • AZD9550

Trial Overview

The study tests the safety of two new drugs, AZD6234 and AZD9550, in people with normal liver function compared to those with moderate or severe long-term liver problems. It looks at how these drugs are tolerated in both groups.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Group 3Experimental Treatment2 Interventions
Group II: Group 2Experimental Treatment2 Interventions
Group III: Group 1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

NCT07546760 | A Phase I Study to Investigate the Effect of ...

The purpose of this study is to examine the safety and tolerability of AZD6234 and AZD9550 in participants with hepatic impairment and participants with normal ...

A Phase I Study to Investigate the Effect of Hepatic ...

The purpose of this study is to examine the safety and tolerability of AZD6234 and AZD9550 in participants with hepatic impairment and ...

AstraZeneca Advances Early Liver-Function Trial That ...

AstraZeneca's new liver function trial could shape future dosing rules for two pipeline drugs, AZD9550 and AZD6234. The Phase I study ...

AZD6234 + AZD9550 for Liver Disease

The purpose of this study is to examine the safety and tolerability of AZD6234 and AZD9550 in participants with hepatic impairment and participants with ...

A study to investigate the effect of AZD6234, AZD9550, and ...

This study will measure the effects of multiple doses of AZD6234, AZD9550 and a combination of AZD9550 and AZD6234 given as injection(s) on pharmacokinetics ...

A Phase I Study to Investigate the Effect of Hepatic Impairment ...

The purpose of this study is to examine the safety and tolerability of AZD6234 and AZD9550 in participants with hepatic impairment and ...