AZD6234 + AZD9550 for Liver Disease

Recruiting at 3 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Antipsychotics, Glucocorticoids, GLP 1, others

Disqualifiers: Diabetes, HIV, Hepatitis, others

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

Compensation: Varies

Number of Visits: 2

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 hepatic function.

Are You a Good Fit for This Trial?

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.

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

How Is the Trial Designed?

Group I: Group 3 Experimental Treatment 2 Interventions

Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the participants with hepatic impairment.

Group II: Group 2 Experimental Treatment 2 Interventions

Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).

Group III: Group 1 Experimental Treatment 2 Interventions

Participants with severe hepatic impairment (CP Class C, score of 10 to 15).

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