AZD2389 for Liver Disease

(CAMPOLINA Trial)

No longer recruiting at 4 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Disqualifiers: HIV, Severe allergy, Dermatological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 48 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, AZD2389, to determine its safety and tolerability in individuals with varying levels of liver disease. The study includes several groups: those with normal liver function and those with mild, moderate, or severe liver impairment. Individuals with stable liver issues or generally good health may qualify for this trial. Researchers aim to understand how the treatment functions in different liver conditions to ensure its safety for future use. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that AZD2389 is likely to be safe for humans?

Previous studies have examined the safety and tolerability of AZD2389, focusing on how the body absorbs, distributes, and metabolizes the drug. Reports so far suggest that AZD2389 is generally well-tolerated, with no major safety concerns or serious side effects. However, as this is an early-stage study, researchers continue to monitor the treatment closely to gather more safety information. For those considering joining a trial, this indicates that the drug has shown promise but remains under careful evaluation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for liver disease rely on managing symptoms and slowing disease progression, often using medications like ursodeoxycholic acid, corticosteroids, or antiviral drugs. But AZD2389 works differently, targeting the liver function directly through a novel mechanism of action that promises to improve liver function across various levels of impairment. Researchers are particularly excited about AZD2389 because it could offer a more targeted approach, potentially providing faster and more effective relief for patients with varying degrees of liver impairment. This new treatment could pave the way for significant advancements in managing liver diseases, especially for those with severe conditions who have limited options.

What evidence suggests that AZD2389 might be an effective treatment for liver disease?

Research on AZD2389 remains in the early stages, focusing on its safety and mechanism of action in the body. Initial studies, including this trial, examine how AZD2389 is absorbed and processed in participants with varying liver function levels, as observed in the different treatment cohorts. Scientists are still determining its potential effectiveness for liver disease. The treatment targets specific pathways related to liver problems, suggesting potential benefits. However, more data is needed to confirm its effectiveness in treating liver disease. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with stable liver impairment or those who are healthy, weighing at least 50 kg with a BMI of 18.0-42.0 kg/m2. It's not for people with severe allergies, HIV, serious skin conditions, or kidney function below a certain level (eGFR <60 mL/min/1.73 m2).

Inclusion Criteria

Healthy: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.

My liver condition is stable.

I weigh at least 50 kg and my BMI is between 18.0 and 42.0.

Exclusion Criteria

History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity

Positive test for HIV at screening

History of severe dermatological disorders

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 AZD2389 and are monitored for pharmacokinetics, safety, and tolerability

48 hours

1 visit (in-patient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AZD2389

Trial Overview The study tests AZD2389's effects on individuals with different levels of liver health to understand its safety and how the body processes it.

How Is the Trial Designed?

Group I: Cohort 4 Experimental Treatment 1 Intervention

Participants with severe hepatic impairment (CP C classification)

Group II: Cohort 3 Experimental Treatment 1 Intervention

Participants with moderate hepatic impairment (CP B classification)

Group III: Cohort 2 Experimental Treatment 1 Intervention

Participants with mild hepatic impairment (CP A classification)

Group IV: Cohort 1 Experimental Treatment 1 Intervention

Participants with normal hepatic function (sex-, age-, and body mass index \[BMI\]-matched)

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

Published Research Related to This Trial

Gene therapy using the AAV-hZFYVE19 vector significantly reduced liver injury markers and improved liver conditions in a mouse model of ZFYVE19 deficiency, particularly at a low dose of 1 × 10^11 vg/kg.

However, higher doses of the AAV-hZFYVE19 vector (5 × 10^12 vg/kg) led to a loss of therapeutic benefits and even worsened liver conditions, indicating that optimal levels of ZFYVE19 expression are crucial for safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Portal-Tract Fibrosis in Zfyve19-/- Mouse Model with Adeno-Associated Virus Vector Delivering ZFYVE19. Zhang, Y., Tang, D., Wang, L., et al.[2023]

In a study of 11 adults with severe alpha1-antitrypsin deficiency but no liver disease symptoms, liver function tests showed no signs of liver damage or abnormal protein synthesis, despite low alpha1-antitrypsin levels.

The hepatic endoplasmic reticulum, which is known to be affected in this condition, did not show impaired function as tested by the aminopyrine breath test, suggesting that liver function may remain intact in the absence of clinical liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver function in asymptomatic adult individuals with severe alpha1-antitrypsin deficiency (Pi Z). Larsson, C., Eriksson, S.[2019]

A patient with a rare genetic condition called homozygous ZZ alpha1-antitrypsin deficiency developed a mixed type of liver cancer (hepatocellular and cholangiolar carcinoma) despite having a noncirrhotic liver.

This case suggests a potential causal link between alpha1-antitrypsin deficiency and the increased risk of liver tumors, highlighting the need for further investigation into this relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alpha1-antitrypsin deficiency and hepatic carcinoma. Schleissner, LA., Cohen, AH.[2004]

A case of severe liver disease due to Alpha-1 Antitrypsin (AAT) deficiency was confirmed through histological examination and immunostaining, highlighting the importance of accurate diagnosis in liver conditions.

Successful liver transplantation reversed the effects of the disease, demonstrating that transplantation can be an effective treatment for advanced liver disease associated with AAT deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End-stage liver disease in a 31-year-old man. Sherman, KE., Goodman, ZD.[2004]

In a study of 23 adults with severe emphysema due to alpha1-antitrypsin deficiency (PiZZ phenotype), 87% were found to have chronic liver disease based on liver biopsy results, indicating a high prevalence of liver involvement in these patients.

Only 8.7% of the patients exhibited severe chronic liver disease, suggesting that while liver histology may show involvement, severe liver dysfunction is relatively rare among those evaluated for lung transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver Involvement in Patients With PiZZ-Emphysema, Candidates for Lung Transplantation. Morer, L., Choudat, L., Dauriat, G., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06812780

NCT06812780 | A Study to Investigate the Effect of Hepatic ... The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06750276

NCT06750276 | A Study to Evaluate the Safety, Tolerability ... The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo ...

3. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D7930C00004

A Study to Investigate the Effect of Hepatic Impairment on ... The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/AZN/pressreleases/33353866/astrazenecas-new-study-on-azd2389-implications-for-hepatic-impairment-treatment/

AstraZeneca's New Study on AZD2389: Implications for ... ' The study aims to evaluate the safety and tolerability of AZD2389 in individuals with varying degrees of liver function, including those with ...

5. withpower.com withpower.com/trial/phase-1-liver-diseases-2-2025-c81f4

AZD2389 for Liver Disease (CAMPOLINA Trial) Only 8.7% of the patients exhibited severe chronic liver disease, suggesting that while liver histology may show involvement, severe liver dysfunction is ...

6. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D7930C00002

A study to evaluate the safety, tolerability, PK, and PD ... The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo ...

7. ctv.veeva.com ctv.veeva.com/study/a-phase-i-study-to-investigate-the-effect-of-hepatic-impairment-on-the-pharmacokinetics-safety-and

A Study to Investigate the Effect of Hepatic Impairment on the ... The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with ...