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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Healthy Participants
• Intervention / Treatment: Drug: AZD1043; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • Not yet recruiting
    • Research Site
• United States
  • California
    • Glendale, California, United States, 91206
      • Recruiting
      • Research Site
  • Maryland
    • Brooklyn, Maryland, United States, 21225
      • Not yet recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A1 (Global SAD): Cohort 1 - AZD1043 (Dose 1); Participants will receive a single dose of AZD1043 (Dose 1) or placebo.	Drug: AZD1043; Single or multiple doses of AZD1043 will be administered.; Other: Placebo; Matching placebo to AZD1043 will be administered.
Experimental: Part A1 (Global SAD): Cohort 2 - AZD1043 (Dose 2); Participants will receive a single dose of AZD1043 (Dose 2) or placebo.	Drug: AZD1043; Single or multiple doses of AZD1043 will be administered.; Other: Placebo; Matching placebo to AZD1043 will be administered.
Experimental: Part A1 (Global SAD): Cohort 3 - AZD1043 (Dose 3); Participants will receive a single dose of AZD1043 (Dose 3) or placebo.	Drug: AZD1043; Single or multiple doses of AZD1043 will be administered.; Other: Placebo; Matching placebo to AZD1043 will be administered.
Experimental: Part A1 (Global SAD): Cohort 4 - AZD1043 (Dose 4); Participants will receive a single dose of AZD1043 (Dose 4) or placebo.	Drug: AZD1043; Single or multiple doses of AZD1043 will be administered.; Other: Placebo; Matching placebo to AZD1043 will be administered.
Experimental: Part A1 (Global SAD): Cohort 5 - AZD1043 (Dose 5); Participants will receive a single dose of AZD1043 (Dose 5) or placebo.	Drug: AZD1043; Single or multiple doses of AZD1043 will be administered.; Other: Placebo; Matching placebo to AZD1043 will be administered.
Experimental: Part A1 (Global SAD): Cohort 6 - AZD1043 (Dose 6); Participants will receive a single dose of AZD1043 (Dose 6) or placebo.	Drug: AZD1043; Single or multiple doses of AZD1043 will be administered.; Other: Placebo; Matching placebo to AZD1043 will be administered.
Experimental: Part A2 (Japanese SAD): Cohort 1 - AZD1043 (Dose X); Japanese participants will receive a single dose of AZD1043 or placebo.	Drug: AZD1043; Single or multiple doses of AZD1043 will be administered.; Other: Placebo; Matching placebo to AZD1043 will be administered.
Experimental: Part A2 (Japanese SAD): Cohort 2 - AZD1043 (Dose Y); Japanese participants will receive a single dose of AZD1043 or placebo.	Drug: AZD1043; Single or multiple doses of AZD1043 will be administered.; Other: Placebo; Matching placebo to AZD1043 will be administered.
Experimental: Part A3 (Chinese SAD): Cohort 1 - AZD1043 (Dose Z); Chinese participants will receive a single dose of AZD1043 or placebo.	Drug: AZD1043; Single or multiple doses of AZD1043 will be administered.; Other: Placebo; Matching placebo to AZD1043 will be administered.
Experimental: Part B1 (Global MAD): Cohort 1 - AZD1043 (Dose A); Participants will receive multiple doses of AZD1043 or placebo.	Drug: AZD1043; Single or multiple doses of AZD1043 will be administered.; Other: Placebo; Matching placebo to AZD1043 will be administered.
Experimental: Part B1 (Global MAD): Cohort 2 - AZD1043 (Dose B); Participants will receive multiple doses of AZD1043 or placebo.	Drug: AZD1043; Single or multiple doses of AZD1043 will be administered.; Other: Placebo; Matching placebo to AZD1043 will be administered.
Experimental: Part B1 (Global MAD): Cohort 3 - AZD1043 (Dose C); Participants will receive multiple doses of AZD1043 or placebo.	Drug: AZD1043; Single or multiple doses of AZD1043 will be administered.; Other: Placebo; Matching placebo to AZD1043 will be administered.
Experimental: Part B2 (Japanese MAD): Cohort 1 - AZD1043 (Dose D); Japanese participants will receive multiple doses of AZD1043 or placebo.	Drug: AZD1043; Single or multiple doses of AZD1043 will be administered.; Other: Placebo; Matching placebo to AZD1043 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	From Day 1 to Day 253

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Publications and helpful links

Helpful Links

• Thank You Card

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Estimated): April 9, 2027
• Study Completion (Estimated): November 17, 2027

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Pharmacodynamics; Multiple ascending dose; Single ascending dose; First time in human
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: D9740C00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.

IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No