AZD1043 safety and dosing in adults with overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1, first-in-human, randomized, single-blind, placebo-controlled trial of AZD1043 in healthy adults living with overweight or obesity. The trial has single ascending dose (SAD) and multiple ascending dose (MAD) parts with separate global, Japanese, and Chinese cohorts to allow careful dose escalation. Female participants must be non-childbearing and all participants go through screening, an in-unit treatment period, and a safety follow-up. Primary measurements are safety, tolerability, pharmacokinetics, and pharmacodynamics after single and repeated dosing.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Glendale, California, United States Recruiting
• Research Site
  Brooklyn, Maryland, United States Recruiting
• Research Site
  Harrow, United Kingdom Not yet recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.