ClinicalTrials.gg
Not yet recruitingNCT07911514Updated Nov 2, 2026

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

A Phase 1 interventional study of AZD9550 solution for injection and AZD6234 solution for injection in Healthy Participants, sponsored by AstraZeneca. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Updated Nov 2, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

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.

Read the detailed description

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.

It plans to randomize 60 healthy men and women aged 18-55 years living with overweight/obesity.

Each volunteer will receive a single dose of test medicine by injection under the skin into the abdomen (tummy), either as 2 separate injections (one of each test medicine) or as a single injection where the test medicines are combined. They'll stay in the clinic for 6 nights on 1 occasion, attend up to 5 outpatient visits, and take up to 9 weeks to finish the study.

Blood and urine samples will be collected to measure the amounts of AZD6234 and AZD9550 and a component of the test medicine, do safety tests, and assess the effect of the test medicine on the immune system.

02

Conditions studied

  • Healthy Participants

Keywords

  • Relative bioavailability
  • Pharmacokinetics
  • Obesity
  • Overweight
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 60 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy males or non-pregnant, non-lactating females aged 18 to 55 years inclusive
  • of 25.0 to 35.0 kg/m2 inclusive and weight ≥50 kg

Exclusion criteria

Exclusion Criteria:

  • History of any 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/ 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
  • ≥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 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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Regimen A

    Participants will receive single concomitant SC injections of AZD9550 solution for injection and AZD6234 solution for injection

    Drug: AZD9550 solution for injection · Drug: AZD6234 solution for injection

  • Experimental
    Regimen B

    Participants will receive a single SC injection of Formulation 1 solution for injection

    Drug: Formulation 1 solution for injection

  • Experimental
    Regimen C

    Participants will receive a single SC injection of Formulation 2 solution for injection

    Drug: Formulation 2 solution for injection

  • Experimental
    Regimen D

    Participants will receive a single SC injection of Formulation 3 solution for injection

    Drug: Formulation 3 solution for injection

  • Experimental
    Regimen E

    Participants will receive a single SC injection of Formulation 4 solution for injection

    Drug: Formulation 4 solution for injection

Interventions

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

    Also known as: AZD9550

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

    Also known as: AZD6234

  • DrugFormulation 1 solution for injection

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

    Also known as: AZD9550+AZD6234

  • DrugFormulation 2 solution for injection

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

    Also known as: AZD9550+AZD6234

  • DrugFormulation 3 solution for injection

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

    Also known as: AZD9550+AZD6234

  • DrugFormulation 4 solution for injection

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

    Also known as: AZD9550+AZD6234

06

What researchers measure

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    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

    Time frame: Plasma sample collection from pre dose to Day 22

  2. Area under the curve from time 0 to the time of last quantifiable concentration (AUClast)

    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

    Time frame: Plasma sample collection from pre dose to Day 22

  3. Area under the curve from time 0 extrapolated to infinity (AUCinf)

    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

    Time frame: Plasma sample collection from pre dose to Day 22

Secondary outcomes

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

    Safety and tolerability of single concomitant doses and different fixed-dose coformulations of AZD9550 and AZD6234 following a single subcutaneous (SC) dose

    Time frame: Through study duration, approximately 9 weeks

  2. Time of maximum observed concentration (tmax)

    Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformulations

    Time frame: Plasma sample collection from pre dose to Day 22

  3. Time of last measurable observed concentration (tlast)

    Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformuations

    Time frame: Plasma sample collection from pre dose to Day 22

  4. Time prior to the first measurable concentration (tlag)

    Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformulations

    Time frame: Plasma sample collection from pre dose to Day 22

  5. Terminal elimination half-life (t1/2λz)

    Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformulations

    Time frame: Plasma sample collection from pre dose to Day 22

  6. Apparent total body clearance (CL/F)

    Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformulations

    Time frame: Plasma sample collection from pre dose to Day 22

  7. Apparent volume of distribution based on the terminal phase (Vz/F)

    Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformulations

    Time frame: Plasma sample collection from pre dose to Day 22

  8. Mean residence time from time 0 extrapolated to infinity (MRTinf)

    Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformulations

    Time frame: Plasma sample collection from pre dose to Day 22

  9. First order rate constant associated with the terminal (log-linear) portion of the curve (λz)

    Evaluate the pharmacokinetics (PK) of AZD9550 and AZD6234 following a single subcutaneous (SC) concomitant administration or administration as different fixed dose coformulations

    Time frame: Plasma sample collection from pre dose to Day 22

07

Study locations

1 site
  • Research Site
    Ruddington, NG11 6JS, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for May 2027, 5 months later.

Of 334 industry-sponsored phase 1 interventional studies under Obesity, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 5 months is below that.

Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2026
First posted
Nov 2, 2026
StartEst.
Nov 9, 2026
Primary completionEst.
May 4, 2027
CompletionEst.
May 4, 2027
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07911514
Lead sponsor
AstraZeneca
Collaborators
Quotient Sciences
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Nov 9, 2026 (estimated)
Primary completion
May 4, 2027 (estimated)
Completion
May 4, 2027 (estimated)
Last update
Nov 2, 2026

Study contacts

AstraZeneca Clinical Study Information Center
Contact
information.center@astrazeneca.com
1-877-240-9479

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: AZD9550 · AZD6234

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