A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participants Living With Overweight and/or Obesity.
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
104 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for healthy adults with overweight or obesity to test the safety and effects of a new treatment called AZD1043. Participants will receive this treatment either once or multiple times over the study period.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 25 and 39.9 kg/m2 in body mass index.
I weigh at least 50 kg.
I am a healthy adult.
I have a negative pregnancy test if I am female.
I have no recent major medical issues.
I am of Japanese descent if I am in certain parts of the study.
I am of Chinese descent if I am in a certain part of the study.
You may not be able to join if
I have any important disease or disorder.
I have had any major illness or surgery in the last 4 weeks.
I have any severe allergies to medications similar to AZD1043.
I have a history of serious mental health issues in the past 2 years.
I have had any gastrointestinal, liver, or kidney disease.
I have had weight loss medications in the last 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility 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 oop…
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.
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