RecruitingPhase 1NCT07220954

A Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations ofAZD6234

A Phase I, Single-Dose, Open-Label, Sequential, Randomised, Crossover Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations of AZD6234 in Participants Living With Overweight or Obesity


Sponsor

AstraZeneca

Enrollment

21 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of AZD6234. This study will take place at one site in Nottingham, United Kingdom, and will enrol 21 healthy men and women aged 18-55 years.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria2

  • 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 Criteria12

  • History of any clinically important disease or disorder
  • History or presence of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric or gastrointestinal disorder including a history of pancreatitis or gall stones
  • Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the planned first dosing day
  • Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis
  • 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.
  • Any participant who has received an amylin analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer)
  • Participants who report to have previously received AZD6234.
  • Use of any prescribed or non-prescribed medication

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Interventions

DRUGAZD6234 Formulation 1

AZD6234 Formulation 1 will be administered as a single SC injection

DRUGAZD6234 Formulation 2 (low concentration)

AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection

DRUGAZD6234 Formulation 2 (high concentration)

AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection

DRUGAZD6234 Formulation 3

AZD6234 Formulation 3 will be administered as a single SC injection


Locations(1)

Research Site

Ruddington, United Kingdom

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NCT07220954


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