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Looking for participantsPhase1

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

Sponsor: AstraZeneca

NCT ID: NCT07511205

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD1043 (drug), Placebo (other)
How long the study runs
Study runs about 20 months (dates as stated)
About the drug or intervention
AZD1043 — drug: Single or multiple doses of AZD1043 will be administered. · Placebo — other: Matching placebo to AZD1043 will be administered.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 65 Years
Who
All
Number of participants
104
Started
2026-03-30
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for healthy participants
  • • Phase1 - 104 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 65 Years
  • • Diagnosed with healthy participants

Where?

  • • Harrow - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Healthy ParticipantsObesity

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 65 Years
  • Who can join: All genders

Biomarkers mentioned

have a negative

Treatment history

Treatments you must have had:

  • ✓ a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit

What the study is looking for

  • ✓All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.

Who cannot take part

  • ✗History of any clinically important disease or disorder.
  • ✗History or presence of gastrointestinal, liver, or kidney disease or any other condition known to interfere with...
  • ✗Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration...
  • ✗Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or...
  • ✗History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs of a...
See the full criteria
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.

Where Is This Study? (1 UK site)

Research Site

Harrow HA1 3UJ, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09