Healthy ParticipantsPhase 1NCT06942923
A Study to Investigate the Safety, Tolerability and Pharmacodynamics of AZD4144 in Participants With Obesity
A Phase 1 study testing AZD4144 in people with Healthy Participants, run by AstraZeneca at 1 site in Germany.
Trial summary
The aim of this study is to evaluate the safety and tolerability, and pharmacodynamics (PD) of AZD4144 administered as repeated daily oral dosing. 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?
- AZD4144
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- 22 Apr 2025to 29 Sep 2025
- 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
- Serum hsCRP > 2 milligrams per liter (mg/L).
- All females must have a negative pregnancy test at the Screening Visit and at the randomization visit (Visit 2).
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception to avoid pregnancy from the time of first administration of study intervention until 3 months after the Final Follow-up Visit.
- Have a body mass index (BMI) greater than or equal to (≥) 30 and less than or equal to (≤) 45 kilograms per meter^2 (kg/m^2).
Who cannot join
- History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- History of Myocardial infarction (MI), coronary revascularisation, stroke, revascularisation for peripheral arterial disease, or other pre-existing Cardiovascular (CV) diseases.
- History of Diabetes (Type 1 and Type 2) or glycated haemoglobin (HbA1c) ≥6.5%.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Any skin disorder, history of, or ongoing clinically significant allergy/hypersensitivity.
- Clinically significant serious active and chronic infections within 60 days prior to randomization.
- Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomised, Investigator- and Participant-blinded, Placebo-Controlled, Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Obesity
The aim of this study is to evaluate the safety and tolerability, and pharmacodynamics (PD) of AZD4144 administered as repeated daily oral dosing.
Read the detailed description
This is placebo-controlled, parallel group and single centre study in healthy male and female participants with obesity and no known Atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), or Type 2 Diabetes Mellitus.
Participants will be randomized in the ratio of 1:1 to receive either AZD4144 or placebo.
This study will comprise of:
- A screening period of 28 days.
- The treatment duration will be up to 28 days.
- The visit frequency will be weekly up to a Follow-up Visit, followed by a Final Follow-up Visit 28 days after the final dose of AZD4144.
- Conditions
- Healthy Participants
- Being tested
- AZD4144, Placebo
- Keywords
- Cardiorenal disease, Atherosclerotic cardiovascular disease, Chronic kidney disease, Type 2 Diabetes Mellitus, Atherosclerosis, Obesity
- Medical subject headings
- Atherosclerosis, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4144Drug
AZD4144 will be administered orally as per arms they have been assigned.
PlaceboDrug
Placebo will be administered orally as per arms they have been assigned.
| Study group | Role | What they receive |
|---|---|---|
| AZD4144 | Experimental | Participants will receive a single oral dose of AZD4144 under fasted conditions once daily for 28 days. Receives: Drug: AZD4144 |
| Placebo | Placebo comparator | Participants will receive a single oral dose of matching placebo to AZD4144 under fasted conditions once daily for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
The safety and tolerability of AZD4144 compared with placebo will be assessed.
Measured: From Screening (Day -28 to Day -2) to final follow-up (Day 56)
Relative change from baseline in systemic interleukin-6 (IL-6) levels
The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be assessed.
Measured: From baseline to 4 weeks
Secondary outcomes (5)
Relative change from baseline in systemic IL-18 levels
The effect of AZD4144 compared with placebo on circulating biomarker IL-18 will be assessed.
Measured: From baseline to 4 weeks
Relative change from baseline in high-sensitivity C-reactive protein (hsCRP) levels
The effect of AZD4144 compared with placebo on circulating biomarker hsCRP will be assessed.
Measured: From baseline to 4 weeks
Observed lowest concentration before the next dose is administered (Ctrough) of AZD4144
The pharmacokinetics (PK) of AZD4144 in participants with obesity will be assessed.
Measured: From Day 1 to Day 28
Maximum observed drug concentration (Cmax) of AZD4144
The PK of AZD4144 in participants with obesity will be assessed.
Measured: From Day 1 to Day 28
Time to reach maximum observed concentration (tmax) of AZD4144
The PK of AZD4144 in participants with obesity will be assessed.
Measured: From Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start22 Apr 2025
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942923
- Sponsor's protocol ID
- D9441C00004
- Status last verified
- Oct 2025
- First submitted
- 17 Apr 2025
- Last updated
- 7 Oct 2025
- 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 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 approved.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Investigator- and Participant-blinded, Placebo-Controlled, Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Obesity
- ClinicalTrials.gov ID
- NCT06942923
- Acronym / sponsor ID
- D9441C00004
- Conditions
- Healthy Participants
- Keywords
- Cardiorenal disease, Atherosclerotic cardiovascular disease, Chronic kidney disease, Type 2 Diabetes Mellitus, Atherosclerosis, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 24 Apr 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.
The aim of this study is to evaluate the safety and tolerability, and pharmacodynamics (PD) of AZD4144 administered as repeated daily oral dosing.
Detailed description
This is placebo-controlled, parallel group and single centre study in healthy male and female participants with obesity and no known Atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), or Type 2 Diabetes Mellitus.
Participants will be randomized in the ratio of 1:1 to receive either AZD4144 or placebo.
This study will comprise of:
- A screening period of 28 days.
- The treatment duration will be up to 28 days.
- The visit frequency will be weekly up to a Follow-up Visit, followed by a Final Follow-up Visit 28 days after the final dose of AZD4144.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD4144 | Experimental | Drug: AZD4144Participants will receive a single oral dose of AZD4144 under fasted conditions once daily for 28 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single oral dose of matching placebo to AZD4144 under fasted conditions once daily for 28 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Serum hsCRP > 2 milligrams per liter (mg/L).
- All females must have a negative pregnancy test at the Screening Visit and at the randomization visit (Visit 2).
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception to avoid pregnancy from the time of first administration of study intervention until 3 months after the Final Follow-up Visit.
- Have a body mass index (BMI) greater than or equal to (≥) 30 and less than or equal to (≤) 45 kilograms per meter^2 (kg/m^2).
Key exclusion criteria (8 listed)
- History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- History of Myocardial infarction (MI), coronary revascularisation, stroke, revascularisation for peripheral arterial disease, or other pre-existing Cardiovascular (CV) diseases.
- History of Diabetes (Type 1 and Type 2) or glycated haemoglobin (HbA1c) ≥6.5%.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
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 |
|---|---|---|
| AZD4144AZD4144 will be administered orally as per arms they have been assigned. | Drug | AZD4144 |
| PlaceboPlacebo will be administered orally as per arms they have been assigned. | Drug | Placebo |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: From Screening (Day -28 to Day -2) to final follow-up (Day 56)
The safety and tolerability of AZD4144 compared with placebo will be assessed.
Relative change from baseline in systemic interleukin-6 (IL-6) levels
Time frame: From baseline to 4 weeks
The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be assessed.
5 secondary outcomes
Relative change from baseline in systemic IL-18 levels
Time frame: From baseline to 4 weeks
Relative change from baseline in high-sensitivity C-reactive protein (hsCRP) levels
Time frame: From baseline to 4 weeks
Observed lowest concentration before the next dose is administered (Ctrough) of AZD4144
Time frame: From Day 1 to Day 28
Maximum observed drug concentration (Cmax) of AZD4144
Time frame: From Day 1 to Day 28
Time to reach maximum observed concentration (tmax) of AZD4144
Time frame: From Day 1 to Day 28
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 7 Oct 2025.
- Individual participant dataSharing planned: 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 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 AZD4144 in people with Healthy Participants, run by AstraZeneca at 1 site in Germany.
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 4 inclusion and 8 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 7 Oct 2025. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Number of Participants with Adverse Events (AEs) (time frame: From Screening (Day -28 to Day -2) to final follow-up (Day 56)). The study lists 2 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 7 Oct 2025.