Healthy ParticipantsPhase 1NCT07511205
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participants Living With Overweight and/or Obesity.
A Phase 1 study testing AZD1043 in people with Healthy Participants and Obesity, run by AstraZeneca at 3 sites in 2 countries.
Trial summary
The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single and multiple ascending doses in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Obesity
- What is being tested?
- AZD1043
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Mar 2026to 17 Nov 2027
- Phase
- Phase 1
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
- Have a body mass index between 25 and 39.9 kg/m2 (Global cohorts [Parts A1 and B1]), or 23 and 39.9 kg/m2 (Japanese [Parts A2 and B2] and Chinese [Part A3] cohorts) inclusive and weigh at least 50 kg.
- For the Parts A2 and B2, participants should be Japanese (natives of Japan or Japanese Americans), having both parents and 4 grandparents who are Japanese. This includes healthy second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
- For the Part A3, participants should be Chinese defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.
Who cannot join
- History of any clinically important disease or disorder.
- 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 clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs of a similar class to AZD1043.
- Has received prescription, non-prescription, or experimental medications for weight loss within 3 months prior to the Screening Visit.
- History of psychosis or bipolar disorder or major depressive disorder within the past 2 years with the participant being clinically unstable.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Research Site
Brooklyn, Maryland, 21225
- Recruiting
Research Site
Glendale, California, 91206
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Research Site
Harrow, HA1 3UJ
About this study
Official title: A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1043 Following Single and Multiple Ascending Doses Via Subcutaneous and/or Intravenous Administration in Healthy Adult Participants Living With Overweight and/or Obesity.
The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single and multiple ascending doses in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.
Read the detailed description
This is a phase 1, first time in human (FTiH) randomized, single-blind, placebo-controlled study in healthy male and female participants living with overweight and/or obesity, with female participants being of non-childbearing potential. It consists of 2 parts:
Part A (single ascending doses: SAD): This will consist of Part A1 (Global SAD (GSAD)) with 6 cohorts, Part A2 (Japanese SAD (JSAD)) with 2 cohorts and Part A3 (Chinese SAD (CSAD)) with 1 cohort.
Part B (multiple ascending doses: MAD): This will consist of Part B1 (Global MAD (GMAD)) with 3 cohorts and Part B2 (Japanese MAD (JMAD)) with 1 cohort.
Participants are only allowed to participate in one of the cohorts.
Both Part A and Part B will comprise of:
- Screening period (up to 5 weeks).
- Treatment period.
- Safety follow-up period.
- Conditions
- Healthy Participants, Obesity
- Being tested
- AZD1043, Placebo
- Keywords
- First time in human, Single ascending dose, Multiple ascending dose, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1043Drug
Single or multiple doses of AZD1043 will be administered.
PlaceboOther
Matching placebo to AZD1043 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part A1 (Global SAD): Cohort 1 - AZD1043 (Dose 1) | Experimental | Participants will receive a single dose of AZD1043 (Dose 1) or placebo. Receives: Drug: AZD1043; Other: Placebo |
| Part A1 (Global SAD): Cohort 2 - AZD1043 (Dose 2) | Experimental | Participants will receive a single dose of AZD1043 (Dose 2) or placebo. Receives: Drug: AZD1043; Other: Placebo |
| Part A1 (Global SAD): Cohort 3 - AZD1043 (Dose 3) | Experimental | Participants will receive a single dose of AZD1043 (Dose 3) or placebo. Receives: Drug: AZD1043; Other: Placebo |
| Part A1 (Global SAD): Cohort 4 - AZD1043 (Dose 4) | Experimental | Participants will receive a single dose of AZD1043 (Dose 4) or placebo. Receives: Drug: AZD1043; Other: Placebo |
| Part A1 (Global SAD): Cohort 5 - AZD1043 (Dose 5) | Experimental | Participants will receive a single dose of AZD1043 (Dose 5) or placebo. Receives: Drug: AZD1043; Other: Placebo |
| Part A1 (Global SAD): Cohort 6 - AZD1043 (Dose 6) | Experimental | Participants will receive a single dose of AZD1043 (Dose 6) or placebo. Receives: Drug: AZD1043; Other: Placebo |
| Part A2 (Japanese SAD): Cohort 1 - AZD1043 (Dose X) | Experimental | Japanese participants will receive a single dose of AZD1043 or placebo. Receives: Drug: AZD1043; Other: Placebo |
| Part A2 (Japanese SAD): Cohort 2 - AZD1043 (Dose Y) | Experimental | Japanese participants will receive a single dose of AZD1043 or placebo. Receives: Drug: AZD1043; Other: Placebo |
| Part A3 (Chinese SAD): Cohort 1 - AZD1043 (Dose Z) | Experimental | Chinese participants will receive a single dose of AZD1043 or placebo. Receives: Drug: AZD1043; Other: Placebo |
| Part B1 (Global MAD): Cohort 1 - AZD1043 (Dose A) | Experimental | Participants will receive multiple doses of AZD1043 or placebo. Receives: Drug: AZD1043; Other: Placebo |
| Part B1 (Global MAD): Cohort 2 - AZD1043 (Dose B) | Experimental | Participants will receive multiple doses of AZD1043 or placebo. Receives: Drug: AZD1043; Other: Placebo |
| Part B1 (Global MAD): Cohort 3 - AZD1043 (Dose C) | Experimental | Participants will receive multiple doses of AZD1043 or placebo. Receives: Drug: AZD1043; Other: Placebo |
| Part B2 (Japanese MAD): Cohort 1 - AZD1043 (Dose D) | Experimental | Japanese participants will receive multiple doses of AZD1043 or placebo. Receives: Drug: AZD1043; Other: 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), serious adverse events (SAEs), AE leading to discontinuation (DAEs), and AEs of special interest (AESIs)
To assess the safety and tolerability of a single or multiple doses of AZD1043 in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.
Measured: Part A (SAD): From Day-35 to Day 253; Part B (MAD): From Day 1 to Day 253
Secondary outcomes (3)
Area under concentration-time curve from time 0 to infinity (AUCinf) (Part A only)
To characterize the PK of a single or multiple doses of AZD1043 in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.
Measured: From Day 1 to Day 253
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the PK of a single or multiple doses of AZD1043 in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.
Measured: From Day 1 to Day 253
Maximum observed drug concentration (Cmax)
To characterize the PK of a single or multiple doses of AZD1043 in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.
Measured: From Day 1 to Day 253
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start30 Mar 2026
- Primary completion9 Apr 2027 (estimated)
- Study completion17 Nov 2027 (estimated)
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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511205
- Sponsor's protocol ID
- D9740C00001
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2026
- Last updated
- 13 Oct 2026
- 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 shared.