NCT07546760

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
9mo left

Started Mar 2026

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Mar 2026Feb 2027

First Submitted

Initial submission to the registry

March 11, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2027

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

March 11, 2026

Last Update Submit

May 4, 2026

Conditions

Hepatic Impairment

Keywords

ModerateSevereMatched Healthy Controls

Outcome Measures

Primary Outcomes (3)

  • PK parameters AUCinf

    To compare the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment with matched controls with normal hepatic function

    Day 0 through Day 56

  • PK parameters AUClast

    To compare the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment with matched controls with normal hepatic function

    Day 0 through Day 56

  • PK parameters Cmax

    To compare the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment with matched controls with normal hepatic function

    Day 0 through Day 56

Secondary Outcomes (5)

  • PK parameters tmax

    Day 0 through Day 56

  • Prevalence and incidence of ADAs to AZD9550 and AZD6234

    Day 0 through Day 56

  • PK parameters t1/2λz

    Day 0 through Day 56

  • PK parameters CL/F

    Day 0 through Day 56

  • PK parameters Vz/F

    Day 0 through Day 56

Other Outcomes (1)

  • Incidence of AEs, SAEs

    Screening through Day 56

Study Arms (3)

Group 1

EXPERIMENTAL

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

Drug: AZD6234Drug: AZD9550

Group 2

EXPERIMENTAL

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

Drug: AZD6234Drug: AZD9550

Group 3

EXPERIMENTAL

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

Drug: AZD6234Drug: AZD9550

Interventions

AZD6234DRUG

Single subcutaneous dose of AZD6234 in participants from all groups

Group 1Group 2Group 3
AZD9550DRUG

Single subcutaneous dose of AZD9550 in participants from all groups

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-85 years at consent.
  • Groups:
  • Healthy controls: Medically healthy; no clinically significant findings in history, exam, labs, vitals, or 12 lead ECG (per investigator).
  • Hepatic impairment: Chronic (≥6 months), stable; documented Child Pugh B (Group 2) or C (Group 1).
  • Stable concomitant regimen ≥2 weeks before screening (Groups 1-2).
  • T2DM allowed if HbA1c \<10% and no severe hypo/hyperglycaemia or hospitalisation within 6 months.
  • Body weight ≥50 kg; BMI 18-42 kg/m².
  • Sex assigned at birth (male/female); contraception per local regulations. Females of child bearing potential: negative pregnancy tests and condoms plus one highly effective method through 54 days post last dose. Males: condom use; no sperm donation through 54 days post last dose.
  • Written informed consent; separate consent for optional genomics.

You may not qualify if:

  • Healthy controls only:
  • Any clinically significant disease; Diabetes;
  • lab values i) ALT/AST/ALP \>1.5×ULN; ii) WBC/platelets \<LLN; iii) haemoglobin \<11.0 g/dL (female) or \<12.0 g/dL (male); aPTT or PT/INR \>1.2×ULN; iv) total bilirubin \>1.5×ULN (or Gilbert's);
  • abnormal resting vital signs i) SBP \>150 or \<90 mmHg, ii) DBP \>95 or \<50 mmHg, iii) pulse ≥100 or ≤45 bpm;
  • QTcF \>450 ms or clinically significant ECG abnormalities;
  • severe allergy/hypersensitivity;
  • major surgery within 30 days;
  • pancreatitis or pancreatic enzymes \>2×ULN;
  • triglycerides \>500 mg/dL (5.6 mmol/L);
  • calcitonin \>50 ng/L (50 pg/mL);
  • severe vitamin D deficiency (\<12 ng/mL, 30 nmol/L);
  • low corrected or ionised calcium;
  • HIV positive; HBV surface/core Ab or HCV Ab positive; drug/alcohol abuse within 1 year.
  • Hepatically impaired only:
  • Unstable medical/psychological conditions or uncontrolled systemic disease;
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Chandler, Arizona, 85225, United States

RECRUITING

Research Site

Rialto, California, 92377, United States

RECRUITING

Research Site

Miami Lakes, Florida, 33014, United States

RECRUITING

Research Site

San Antonio, Texas, 78215, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be enrolled into the following groups based on their CP classification score as determined by a local laboratory at screening: Group 1: Participants with severe hepatic impairment (CP Class C, score of 10 to 15). Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). Group 3: Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the participants with hepatic impairment.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2026

First Posted

April 23, 2026

Study Start

March 20, 2026

Primary Completion (Estimated)

February 4, 2027

Study Completion (Estimated)

February 4, 2027

Last Updated

May 5, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

US(4)