A Study of AZD1043 for Overweight and Obesity

This study is testing a new drug called AZD1043 in healthy adults who are overweight or have obesity. Researchers want to learn about how safe AZD1043 is, how well your body handles it (tolerability), and how it moves through and affects your body (pharmacokinetics and pharmacodynamics). Some participants will receive AZD1043, while others will receive a placebo (an inactive substance that looks like the drug). The main goal is to track any side effects. You may be able to join if you are between 18 and 65 years old, have a Body Mass Index (BMI) between 25 and 39, and, if you are female, are unable to become pregnant. This study is currently recruiting about 104 participants.

Study design
This is a Phase 1, first-in-human study that is randomized, single-blind, and placebo-controlled. It will include about 104 participants.
What's involved
You will go through a screening period (up to 5 weeks), a treatment period where you receive AZD1043 or placebo, and a safety follow-up period.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 253 days after starting treatment.

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NCT07511205

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
AstraZeneca
~104 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:AZD1043Placebo

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs), serious adverse events (SAEs), AE leading to discontinuation (DAEs), and AEs of special interest (AESIs)
Measured over Part A (SAD): From Day-35 to Day 253; Part B (MAD): From Day 1 to Day 253
Healthy Participants
Obesity
3 sites across 3 states
California1
Maryland1
United Kingdom1
AstraZeneca Clinical Study Information Center
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

    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.