Healthy ParticipantsPhase 1NCT07220954
A Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations ofAZD6234
A Phase 1 study testing AZD6234 Formulation 1, AZD6234 Formulation 2 (low concentration) and AZD6234 Formulation 2 (high concentration) in people with Healthy Participants, run by AstraZeneca at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD6234 Formulation 1, AZD6234 Formulation 2 (low concentration) and AZD6234 Formulation 2 (high concentration)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2025to 16 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Healthy Participants
- Being tested
- AZD6234 Formulation 1, AZD6234 Formulation 2 (low concentration), AZD6234 Formulation 2 (high concentration), AZD6234 Formulation 3
- Keywords
- Relative Bioavailability, Pharmacokinetics, Obesity, Overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6234 Formulation 1Drug
Also called AZD6234
AZD6234 Formulation 1 will be administered as a single SC injection
AZD6234 Formulation 2 (low concentration)Drug
Also called AZD6234
AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection
AZD6234 Formulation 2 (high concentration)Drug
Also called AZD6234
AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection
AZD6234 Formulation 3Drug
Also called AZD6234
AZD6234 Formulation 3 will be administered as a single SC injection
| Study group | Role | What they receive |
|---|---|---|
| Sequence ABCD | Experimental | Participants will receive a single SC injection of AZD6234 in each of four study periods, Treatment A in Period 1, Treatment B in Period 2, Treatment C in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3) Receives: Drug: AZD6234 Formulation 1; Drug: AZD6234 Formulation 2 (low concentration); Drug: AZD6234 Formulation 2 (high concentration); Drug: AZD6234 Formulation 3 |
| Sequence BCAD | Experimental | Participants will receive a single SC injection of AZD6234 in each of four study periods, Treatment B in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3) Receives: Drug: AZD6234 Formulation 1; Drug: AZD6234 Formulation 2 (low concentration); Drug: AZD6234 Formulation 2 (high concentration); Drug: AZD6234 Formulation 3 |
| Sequence CABD | Experimental | Participants will receive a single SC injection of AZD6234 in each of four study periods, Treatment C in Period 1, Treatment A in Period 2, Treatment B in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3) Receives: Drug: AZD6234 Formulation 1; Drug: AZD6234 Formulation 2 (low concentration); Drug: AZD6234 Formulation 2 (high concentration); Drug: AZD6234 Formulation 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations
Measured: Plasma sample collection from pre- dose to 30 days post final dose
Area under the concentration-time curve from time 0 to the time of the last measurable concentration (AUC0-t)
Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations
Measured: Plasma sample collection from pre- dose to 30 days post final dose
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations
Measured: Plasma sample collection from pre- dose to 30 days post final dose
Secondary outcomes (5)
Number of subjects with adverse events (AEs)/serious AEs (SAEs), and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests
Safety and tolerability of different AZD6234 SC formulations
Measured: Through study duration, approximately 19 weeks
Time of maximum observed plasma concentration (tmax)
Pharmacokinetics (PK) of different AZD6234 SC formulations
Measured: Plasma sample collection from pre- dose to 30 days post final dose
Terminal elimination half-life (t1/2)
Pharmacokinetics (PK) of different AZD6234 SC formulations
Measured: Plasma sample collection from pre- dose to 30 days post final dose
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F)
Pharmacokinetics (PK) of different AZD6234 SC formulations
Measured: Plasma sample collection from pre- dose to 30 days post final dose
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)
Pharmacokinetics (PK) of different AZD6234 SC formulations
Measured: Plasma sample collection from pre- dose to 30 days post final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start11 Nov 2025
- Primary completion16 Sep 2026
- Study completion16 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to 1 of 3 treatment sequences
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220954
- Sponsor's protocol ID
- D8750C00008
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual participant-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 approved.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07220954
- Acronym / sponsor ID
- D8750C00008
- Conditions
- Healthy Participants
- Keywords
- Relative Bioavailability, Pharmacokinetics, Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 16 Sep 2026 (actual)
- Study completion
- 16 Sep 2026 (actual)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized to 1 of 3 treatment sequences
| Arm | Type | Receives |
|---|---|---|
| Sequence ABCD | Experimental | Drug: AZD6234 Formulation 1, Drug: AZD6234 Formulation 2 (low concentration), Drug: AZD6234 Formulation 2 (high concentration), Drug: AZD6234 Formulation 3Participants will receive a single SC injection of AZD6234 in each of four study periods, Treatment A in Period 1, Treatment B in Period 2, Treatment C in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3) |
| Sequence BCAD | Experimental | Drug: AZD6234 Formulation 1, Drug: AZD6234 Formulation 2 (low concentration), Drug: AZD6234 Formulation 2 (high concentration), Drug: AZD6234 Formulation 3Participants will receive a single SC injection of AZD6234 in each of four study periods, Treatment B in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3) |
| Sequence CABD | Experimental | Drug: AZD6234 Formulation 1, Drug: AZD6234 Formulation 2 (low concentration), Drug: AZD6234 Formulation 2 (high concentration), Drug: AZD6234 Formulation 3Participants will receive a single SC injection of AZD6234 in each of four study periods, Treatment C in Period 1, Treatment A in Period 2, Treatment B in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD6234 Formulation 1Also: AZD6234AZD6234 Formulation 1 will be administered as a single SC injection | Drug | Sequence ABCD, Sequence BCAD, Sequence CABD |
| AZD6234 Formulation 2 (low concentration)Also: AZD6234AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection | Drug | Sequence ABCD, Sequence BCAD, Sequence CABD |
| AZD6234 Formulation 2 (high concentration)Also: AZD6234AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection | Drug | Sequence ABCD, Sequence BCAD, Sequence CABD |
| AZD6234 Formulation 3Also: AZD6234AZD6234 Formulation 3 will be administered as a single SC injection | Drug | Sequence ABCD, Sequence BCAD, Sequence CABD |
Primary outcome
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
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
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
5 secondary outcomes
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
Time of maximum observed plasma concentration (tmax)
Time frame: Plasma sample collection from pre- dose to 30 days post final dose
Terminal elimination half-life (t1/2)
Time frame: Plasma sample collection from pre- dose to 30 days post final dose
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual participant-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 approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD6234 Formulation 1, AZD6234 Formulation 2 (low concentration) and AZD6234 Formulation 2 (high concentration) in people with Healthy Participants, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) (time frame: Plasma sample collection from pre- dose to 30 days post final dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.