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Starting soon Phase 1

A Trial to Assess the Relative Bioavailability of Different Subcutaneous Formulations of AZD9550 and AZD6234

NCT07911514 · tracked via the Priya Life Science UK tracker
Phase
Phase 1
Started
2026-11-09
Last updated
2026-11-02

Condition(s) studied

Healthy Participants

Investigational drug(s) / intervention(s)

AZD9550 solution for injection →AZD6234 solution for injection →Formulation 1 solution for injectionFormulation 2 solution for injectionFormulation 3 solution for injectionFormulation 4 solution for injection

AZD9550 solution for injection: AZD9550 solution for injection will be administered as a single SC injection

AZD6234 solution for injection: AZD6234 solution for injection will be administered as a single SC injection

Formulation 1 solution for injection: Formulation 1 solution for injection will be administered as a single SC injection

Formulation 2 solution for injection: Formulation 2 solution for injection will be administered as a single SC injection

Formulation 3 solution for injection: Formulation 3 solution for injection will be administered as a single SC injection

Formulation 4 solution for injection: Formulation 4 solution for injection will be administered as a single SC injection

Study summary

This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of two test medicines, AZD9550 and AZD6234.

This study will take place at one site in Nottingham, United Kingdom, and will randomize 60 healthy men and women aged 18-55 years living with overweight/obesity.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Healthy males or non-pregnant, non-lactating females aged 18 to 55 years inclusive * BMI of 25.0 to 35.0 kg/m2 inclusive and weight ≥50 kg Exclusion Criteria: * History of any clinically important disease or disorder * History or presence of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric or GI disorder including a history of pancreatitis or gall stones * History of suicidal ideation or behaviour * Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of dosing * History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to any component of the AZD6234 or AZD9550 drug products * Prior or planned bariatric surgery or placement of a weight loss device * Participants who do not have suitable veins for multiple venepunctures/cannulation * Skin disorder/condition or tattoos in the abdominal area of the proposed injection site which can interfere with study assessments * Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis * Basal calcitonin level \> 50 ng/L * Any clinically significant abnormal findings in vital signs * Any clinically significant abnormalities on 12-lead ECG * HbA1c ≥6.5% (≥48 mmol/mol) * Evidence of renal impairment * Females who are pregnant or lactating * Participants who have received any IMP in the last 90 days prior to dosing * Participants who have previously received AZD9550 and/or AZD6234 * Treatment with prescription or non-prescription medication intended for weight loss within 3 months before screening * Treatment with a GLP-1-containing preparation within 3 months before screening * Treatment with an amylin analogue containing preparation within 30 days before screening * Treatment with medication for diabetes within 3 months before screening * Treatment with medication associated with significant weight gain in the 3 months before screening * Plasma donation within 3 months of screening or any blood donation/loss more than 500 mL within 3 months before screening * Use of any prescribed or non-prescribed medication including antacids, gastric pH modifying agents, analgesics, herbal remedies, vitamins and minerals within 2 weeks of dosing * Use of drugs or herbal medications with CYP3A4 enzyme-inducing properties within 3 weeks of dosing * Current smokers or known or suspected history of alcohol or drug abuse * Excessive intake of caffeine-containing drinks or food

Primary outcome measure(s)

  • Maximum observed plasma concentration (Cmax) — Plasma sample collection from pre dose to Day 22
    Assess the relative bioavailability (rBA) and compare single subcutaneous (SC) dose pharmacokinetics (PK) of concomitant doses of AZD9550 and AZD6234 to different fixed-dose coformulations
  • Area under the curve from time 0 to the time of last quantifiable concentration (AUClast) — Plasma sample collection from pre dose to Day 22
    Assess the relative bioavailability (rBA) and compare the single subcutaneous (SC) dose pharmacokinetics (PK) of concomitant doses of AZD9550 and AZD6234 to different fixed-dose coformulations
  • Area under the curve from time 0 extrapolated to infinity (AUCinf) — Plasma sample collection from pre dose to Day 22
    Assess the relative bioavailability (rBA) and compare the single subcutaneous (SC) dose pharmacokinetics (PK) of concomitant doses of AZD9550 and AZD6234 to different fixed-dose coformulations

Trial sites (1)

FacilityCityRegionStatus
Research Site Ruddington United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07911514 on ClinicalTrials.gov ↗ ← All trials in the UK