A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participants Living With Overweight and/or Obesity.

NCT07511205 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: D9740C00001
• Study Type: interventional
• Target: 104
• Locations: 2 countries
• Sites: 2

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

Obesity; Healthy Participants

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  From Day 1 to Day 253

• Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

  From Day 1 to Day 253

• Maximum observed drug concentration (Cmax)

  From Day 1 to Day 253

Study Arms (13)

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

EXPERIMENTAL

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

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.

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.

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.

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.

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.

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.

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.

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.

Drug: AZD1043; Other: Placebo

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

EXPERIMENTAL

Participants will receive multiple doses of AZD1043 or placebo.

Drug: AZD1043; Other: Placebo

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

EXPERIMENTAL

Participants will receive multiple doses of AZD1043 or placebo.

Drug: AZD1043; Other: Placebo

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

EXPERIMENTAL

Participants will receive multiple doses of AZD1043 or placebo.

Drug: AZD1043; Other: Placebo

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

EXPERIMENTAL

Japanese participants will receive multiple doses of AZD1043 or placebo.

Drug: AZD1043; Other: Placebo

Interventions

AZD1043 DRUG

Single or multiple doses of AZD1043 will be administered.

Part A1 (Global SAD): Cohort 1 - AZD1043 (Dose 1); Part A1 (Global SAD): Cohort 2 - AZD1043 (Dose 2); Part A1 (Global SAD): Cohort 3 - AZD1043 (Dose 3); Part A1 (Global SAD): Cohort 4 - AZD1043 (Dose 4); Part A1 (Global SAD): Cohort 5 - AZD1043 (Dose 5); Part A1 (Global SAD): Cohort 6 - AZD1043 (Dose 6); Part A2 (Japanese SAD): Cohort 1 - AZD1043 (Dose X); Part A2 (Japanese SAD): Cohort 2 - AZD1043 (Dose Y); Part A3 (Chinese SAD): Cohort 1 - AZD1043 (Dose Z); Part B1 (Global MAD): Cohort 1 - AZD1043 (Dose A); Part B1 (Global MAD): Cohort 2 - AZD1043 (Dose B); Part B1 (Global MAD): Cohort 3 - AZD1043 (Dose C); Part B2 (Japanese MAD): Cohort 1 - AZD1043 (Dose D)

Placebo OTHER

Matching placebo to AZD1043 will be administered.

Part A1 (Global SAD): Cohort 1 - AZD1043 (Dose 1); Part A1 (Global SAD): Cohort 2 - AZD1043 (Dose 2); Part A1 (Global SAD): Cohort 3 - AZD1043 (Dose 3); Part A1 (Global SAD): Cohort 4 - AZD1043 (Dose 4); Part A1 (Global SAD): Cohort 5 - AZD1043 (Dose 5); Part A1 (Global SAD): Cohort 6 - AZD1043 (Dose 6); Part A2 (Japanese SAD): Cohort 1 - AZD1043 (Dose X); Part A2 (Japanese SAD): Cohort 2 - AZD1043 (Dose Y); Part A3 (Chinese SAD): Cohort 1 - AZD1043 (Dose Z); Part B1 (Global MAD): Cohort 1 - AZD1043 (Dose A); Part B1 (Global MAD): Cohort 2 - AZD1043 (Dose B); Part B1 (Global MAD): Cohort 3 - AZD1043 (Dose C); Part B2 (Japanese MAD): Cohort 1 - AZD1043 (Dose D)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (2)

Research Site

Glendale, California, 91206, United States

RECRUITING

Research Site

Harrow, HA1 3UJ, United Kingdom

NOT YET RECRUITING

Related Links

• Thank You Card

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 6, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): October 21, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1); GB (1)