Recruiting
Phase 1

AZD1043

Sponsor:

AstraZeneca

Code:

NCT07511205

Conditions

Healthy Participants

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

AZD1043

Placebo

Study Details

Brief 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.

Conditions

Healthy Participants

Obesity

Study ID

NCT07511205

Start date

Mar 30, 2026

Status verified date

Sep, 2026

Completion date

Nov 17, 2027

Anticipated

Primary completion date

Apr 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A1 (Global SAD): Cohort 1 - AZD1043 (Dose 1)

Participants will receive a single dose of AZD1043 (Dose 1) or placebo.

experimental: Part A1 (Global SAD): Cohort 2 - AZD1043 (Dose 2)

Participants will receive a single dose of AZD1043 (Dose 2) or placebo.

experimental: Part A1 (Global SAD): Cohort 3 - AZD1043 (Dose 3)

Participants will receive a single dose of AZD1043 (Dose 3) or placebo.

experimental: Part A1 (Global SAD): Cohort 4 - AZD1043 (Dose 4)

Participants will receive a single dose of AZD1043 (Dose 4) or placebo.

experimental: Part A1 (Global SAD): Cohort 5 - AZD1043 (Dose 5)

Participants will receive a single dose of AZD1043 (Dose 5) or placebo.

experimental: Part A1 (Global SAD): Cohort 6 - AZD1043 (Dose 6)

Participants will receive a single dose of AZD1043 (Dose 6) or placebo.

experimental: Part A2 (Japanese SAD): Cohort 1 - AZD1043 (Dose X)

Japanese participants will receive a single dose of AZD1043 or placebo.

experimental: Part A2 (Japanese SAD): Cohort 2 - AZD1043 (Dose Y)

Japanese participants will receive a single dose of AZD1043 or placebo.

experimental: Part A3 (Chinese SAD): Cohort 1 - AZD1043 (Dose Z)

Chinese participants will receive a single dose of AZD1043 or placebo.

experimental: Part B1 (Global MAD): Cohort 1 - AZD1043 (Dose A)

Participants will receive multiple doses of AZD1043 or placebo.

experimental: Part B1 (Global MAD): Cohort 2 - AZD1043 (Dose B)

Participants will receive multiple doses of AZD1043 or placebo.

experimental: Part B1 (Global MAD): Cohort 3 - AZD1043 (Dose C)

Participants will receive multiple doses of AZD1043 or placebo.

experimental: Part B2 (Japanese MAD): Cohort 1 - AZD1043 (Dose D)

Japanese participants will receive multiple doses of AZD1043 or placebo.

Interventions

AZD1043

Single or multiple doses of AZD1043 will be administered.

Placebo

Matching placebo to AZD1043 will be administered.

Primary outcome measure

  • Number of participants with adverse events (AEs), serious adverse events (SAEs), AE leading to discontinuation (DAEs), and AEs of special interest (AESIs) [ Time Frame: Part A (SAD): From Day-35 to Day 253; Part B (MAD): From Day 1 to Day 253 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Glendale, California, United States, 91206

More Information

Sponsor

AstraZeneca

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • First time in human
  • Single ascending dose
  • Multiple ascending dose
  • Pharmacokinetics
  • Pharmacodynamics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.