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NCT Number: NCT07220954

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

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.

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Key information

Conditions

Healthy Participants Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Ruddington, NG11 6JS, United Kingdom

Location status: Recruiting

About this study

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.

It plans to enrol 21 healthy men and women aged 18-55 years.

Each volunteer will take part in 4 treatment periods and receive different formulations of AZD6234, by injection under the skin into the abdomen (stomach). In each period they'll be given a single dose without food. They'll stay in the clinic for 6 nights on 4 occasions, attend up to 10 outpatient visits, and take up to 19 weeks to finish the study.

Blood and urine samples will be collected to: measure the amount of AZD6234 and its breakdown products, do safety tests and assess the effect of the test medicine on the immune system response.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

AZD6234 Formulation 1

Drug

AZD6234 Formulation 1 will be administered as a single SC injection

Other names: AZD6234

AZD6234 Formulation 2 (low concentration)

Drug

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

Other names: AZD6234

AZD6234 Formulation 2 (high concentration)

Drug

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

Other names: AZD6234

AZD6234 Formulation 3

Drug

AZD6234 Formulation 3 will be administered as a single SC injection

Other names: AZD6234

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Plasma sample collection from pre- dose to 30 days post final dose

    Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations

  2. Area under the concentration-time curve from time 0 to the time of the last measurable concentration (AUC0-t)

    Time frame: Plasma sample collection from pre- dose to 30 days post final dose

    Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations

  3. Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)

    Time frame: Plasma sample collection from pre- dose to 30 days post final dose

    Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations

Secondary outcomes

  1. Number of subjects with adverse events (AEs)/serious AEs (SAEs), and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests

    Time frame: Through study duration, approximately 19 weeks

    Safety and tolerability of different AZD6234 SC formulations

  2. Time of maximum observed plasma concentration (tmax)

    Time frame: Plasma sample collection from pre- dose to 30 days post final dose

    Pharmacokinetics (PK) of different AZD6234 SC formulations

  3. Terminal elimination half-life (t1/2)

    Time frame: Plasma sample collection from pre- dose to 30 days post final dose

    Pharmacokinetics (PK) of different AZD6234 SC formulations

  4. Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F)

    Time frame: Plasma sample collection from pre- dose to 30 days post final dose

    Pharmacokinetics (PK) of different AZD6234 SC formulations

  5. Volume of distribution based on the terminal phase calculated using AUC0-inf after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F)

    Time frame: Plasma sample collection from pre- dose to 30 days post final dose

    Pharmacokinetics (PK) of different AZD6234 SC formulations

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Quotient Sciences

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 24, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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