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Healthy ParticipantsPhase 1NCT06555822

A Study to Investigate Multiple Ascending Doses and Relative Bioavailability of AZD5004 in Healthy Participants

A Phase 1 study testing AZD5004 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to assess the safety, tolerability, and pharmacokinetic (PK) of AZD5004 administered as multiple oral doses in healthy participants and to compare the relative bioavailability of two oral tablet strengths of AZD5004. 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?
AZD5004
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 siteUnited States
Study dates
15 Aug 2024to 6 Mar 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

  • Must have suitable veins for cannulation or repeated venipuncture.
  • Female(s) of Childbearing Potential must use adequate contraception (oral contraceptives are not permitted).
  • Have a BMI ≥ 23 kg/m2 and not exceeding 35 kg/m2 inclusive and weigh at least 60 kg.
  • No or off statin treatment for ≥ 4 weeks prior to the study treatment.

Who cannot join

  • History of any clinically important disease or disorder.
  • History of acute pancreatitis, chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase.
  • History or presence of gastrointestinal, hepatic, or renal disease.
  • Clinically significant hepatic disease, inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper gastrointestinal tract.
  • Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
  • Any clinically important abnormalities in rhythm, blood pressure, heart rate, conduction or morphology of the resting electrocardiogram (ECG).
Show all 14Show fewer
  • Uncontrolled thyroid disease, defined as thyroid-stimulating hormone > 6.0 mIU/L or < 0.4 mIU/L at Screening.
  • Current smokers or known history of alcohol or drug abuse.
  • History of severe allergy/hypersensitivity or excessive intake of caffeine-containing drinks or food.
  • Use of any prescribed or nonprescribed medication including antacids or analgesics.
  • Participants who are on or are planning to undertake a weight loss program.
  • History of psychosis, major depressive disorder, suicide attempt or suicidal ideation within the past year.
  • Lactating, breastfeeding, or pregnant females or females who intend to become pregnant.
  • Participants who are vegans or have medical dietary restrictions.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Research Site

    Brooklyn, Maryland, 21225

Other trials in United States

About this study

Official title: A Phase I, Two-Part Study in Healthy Volunteers Consisting of a Randomized, Single-blind, Placebo-controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5004 and a Randomized, Open-Label, Two-way Cross-over Study to Compare the Relative Bioavailability of Two Oral Tablet Strengths of AZD5004

The main purpose of this study is to assess the safety, tolerability, and pharmacokinetic (PK) of AZD5004 administered as multiple oral doses in healthy participants and to compare the relative bioavailability of two oral tablet strengths of AZD5004.

Read the detailed description

This study comprises of 2 parts - Part A and Part B.

Part A is a placebo-controlled study to assess the safety, efficacy, tolerability, and PK of repeated dosing of AZD5004 compared with placebo.

Participants who are eligible according to the inclusion/exclusion criteria will be randomized to receive AZD5004 or matching placebo.

Part A will comprise:

  1. A Screening Period of maximum 28 days.
  2. A Treatment Period of 106 days.
  3. A final Follow-up Visit approximately 14 days after the last study intervention administration.

Part B is a two-way cross-over study to compare the relative bioavailability of 2 oral tablet strengths of Formulation 1 (F1) of AZD5004.

The purpose of this study is to expand product knowledge between the 2 oral tablet strengths on plasma exposure levels to guide Phase 3 drug product development. The participants will be split into 2 groups. Group 1 will be dosed with Treatment 1 of AZD5004 and then dosed with Treatment 2 of AZD5004. Group 2 will be dosed with Treatment 2 of AZD5004 and then dosed with Treatment 1 of AZD5004.

Part B of the study will comprise:

  1. A Screening Period of maximum 28 days.
  2. Two Treatment Periods, each consisting of 7 days.
  3. A final Follow-up Visit approximately 6 days after the last dose of study intervention administration.
Being tested
AZD5004, Placebo
Keywords
Obesity, Type 2 Diabetes
Medical subject headings
Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD5004Drug

    Also called ECC5004

    Participants will receive oral tablets of AZD5004 in Part A and Part B of the study as per arms they are assigned.

  • PlaceboDrug

    Placebo will be administered as an oral tablet once daily.

Study groups in NCT06555822
Study groupRoleWhat they receive
Part A: Multiple Ascending dose (MAD) (AZD5004)ExperimentalParticipants will receive repeated dosing of AZD5004 orally.
Receives: Drug: AZD5004
Part A: PlaceboPlacebo comparatorParticipants will receive matching Placebo orally.
Receives: Drug: Placebo
Part B: Treatment 1 (AZD5004)ExperimentalParticipants in Group 1 will receive Treatment 1 of AZD5004 and then Treatment 2 of AZD5004. Participants in Group 2 will receive Treatment 2 of AZD5004 and then Treatment 1 of AZD5004.
Receives: Drug: AZD5004
Part B: Treatment 2 (AZD5004)ExperimentalParticipants in Group 1 will receive Treatment 1 of AZD5004 and then Treatment 2 of AZD5004. Participants in Group 2 will receive Treatment 2 of AZD5004 and then Treatment 1 of AZD5004.
Receives: Drug: AZD5004

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    To assess the safety and tolerability of AZD5004 following oral multiple ascending doses in healthy participants.

    Measured: From screening (Day -28) to last follow up visit (Day 120)

  2. Part B: Maximum observed plasma (peak) drug concentration (Cmax) of AZD5004

    To evaluate the Cmax of 2 treatments of AZD5004 in healthy participants.

    Measured: From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)

  3. Part B: Area under the concentration-curve from time zero to the last quantifiable concentration (AUClast)

    To evaluate the AUClast of 2 treatments of AZD5004 in healthy participants.

    Measured: From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)

  4. Part B: Area under concentration-time curve from time 0 to infinity (AUCinf)

    To evaluate the AUCinf of 2 treatments of AZD5004 in healthy participants.

    Measured: From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)

  5. Part B: Time to reach maximum observed concentration (tmax)

    To evaluate the tmax of 2 treatments of AZD5004 in healthy participants.

    Measured: From Day 1 (Treatment Period 1) to Day 13 (end of Treatment Period 2)

Secondary outcomes (11)

  1. Part A: Maximum observed plasma (peak) drug concentration (Cmax) of AZD5004

    To characterize the Cmax of multiple ascending doses of AZD5004 in healthy participants.

    Measured: From Day 1 to last follow up visit (Day 120)

  2. Part A: Area under the concentration-curve from time zero to the last quantifiable concentration (AUClast)

    To characterize the AUClast of multiple ascending doses of AZD5004 in healthy participants.

    Measured: From Day 1 to last follow up visit (Day 120)

  3. Part A: Area under concentration time curve in the dosing interval (AUCtau)

    To characterize the AUCtau of multiple ascending doses of AZD5004 in healthy participants.

    Measured: From Day 1 to last follow up visit (Day 120)

  4. Part A: Amount of unchanged drug excreted into urine from time t1 to time t2 (Ae[t1-t2])

    To characterize the Ae(t1-t2) of multiple ascending doses of AZD5004 in healthy participants.

    Measured: From Day 1 to last follow up visit (Day 120)

  5. Part A: Percentage of dose excreted unchanged in urine from time t1 to time t2 (fe[t1-t2])

    To characterize the fe(t1-t2) of multiple ascending doses of AZD5004 in healthy participants.

    Measured: From Day 1 to last follow up visit (Day 120)

  6. Part A: Renal clearance (CLR)

    To characterize the CLR of multiple ascending doses of AZD5004 in healthy participants.

    Measured: From Day 1 to last follow up visit (Day 120)

  7. Part A: Percentage change from Baseline in body weight (kg)

    To assess the effects of AZD5004 compared to placebo on body weight change from baseline.

    Measured: Baseline (Day - 2) to Days 49, 91, and 106

  8. Part A: Absolute change from Baseline in body weight (kg)

    To assess the effects of AZD5004 compared to placebo on body weight change from baseline.

    Measured: Baseline (Day - 2) to Days 49, 91, and 106

  9. Part A: Percentage change from Baseline in Body Mass Index (BMI) (kg/m^2)

    To assess the effects of AZD5004 compared to placebo on body weight change from baseline.

    Measured: Baseline (Day - 2) to Days 49, 91, and 106

  10. Part A: Absolute change from Baseline in BMI (kg/m^2)

    To assess the effects of AZD5004 compared to placebo on body weight change from baseline.

    Measured: Baseline (Day - 2) to Days 49, 91, and 106

  11. Part B: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    To evaluate the safety and tolerability of 2 treatments of AZD5004 in healthy participants.

    Measured: From screening (Day -28) to last follow up visit (Day 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2024
  2. Study start15 Aug 2024
  3. Primary completion6 Mar 2025
  4. Study completion6 Mar 2025

Resources

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
Single blind
Who is masked
Participant
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06555822
Sponsor's protocol ID
D7260C00004
Status last verified
Mar 2025
First submitted
13 Aug 2024
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD5004 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.

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 14 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 17 Mar 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 United States. 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?

Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (time frame: From screening (Day -28) to last follow up visit (Day 120)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06555822.

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 17 Mar 2025.

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