Early safety study of AZD1043 in adults living with overweight or obesity
Tests AZD1043 for safety in otherwise healthy adults with overweight or obesity.
Key facts
- Who runs it
- AstraZeneca
- Where
- Harrow, United KingdomSee the siteAlso in 1 other country, 2 sites
- Trial code
- Registry title
- A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participants Living With Overweight and/or Obesity.
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 104 people, planned
- Started
- 30 Mar 2026
- Expected to end
- 17 Nov 2027
- Type of study
- Interventional, 13 groups
- Treatments tested
- AZD1043
- Placebo
- Record updated
- 9 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults aged 18 to 65 who live with overweight or obesity, including people of Japanese and Chinese descent, to test the safety of AZD1043.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Body mass index between 25 and 39.9 kg/m2 in the global groups, or between 23 and 39.9 kg/m2 in the Japanese and Chinese groups. Weight of at least 50 kg (110 lb).
- Earlier treatment
- Cannot have taken prescription, non-prescription or experimental weight-loss medicines within 3 months before screening.
- Biomarker or test result
- Women must have a negative pregnancy test at screening and on admission to the clinical unit. Japanese and Chinese groups need both parents and all 4 grandparents of that ethnicity.
Main reasons for not taking part
- History of any clinically important disease or disorder
- Stomach, bowel, liver or kidney disease, or any condition that affects how the body handles drugs
- Clinically important illness, medical or surgical procedure, or trauma within 4 weeks of the first dose
- Severe allergy to drugs of a similar class to AZD1043
- Unstable psychosis, bipolar disorder or major depression within the past 2 years
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Has received prescription, non-prescription, or experimental medications for weight loss within 3 months prior to the Screening Visit
- 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
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs of a similar class to AZD1043
- History of psychosis or bipolar disorder or major depressive disorder within the past 2 years with the participant being clinically unstable
- Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in United Kingdom
Also in 1 other country, 2 sites
- HarrowHospital not named in the registryNot yet recruiting
About the trial
What the trial wants 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.
The 13 groups in the trial
- Part A1 (Global SAD): Cohort 1 - AZD1043 (Dose 1)Treatment being tested
Participants will receive a single dose of AZD1043 (Dose 1) or placebo.
Treatment: AZD1043 and Placebo
- Part A1 (Global SAD): Cohort 2 - AZD1043 (Dose 2)Treatment being tested
Participants will receive a single dose of AZD1043 (Dose 2) or placebo.
Treatment: AZD1043 and Placebo
- Part A1 (Global SAD): Cohort 3 - AZD1043 (Dose 3)Treatment being tested
Participants will receive a single dose of AZD1043 (Dose 3) or placebo.
Treatment: AZD1043 and Placebo
- Part A1 (Global SAD): Cohort 4 - AZD1043 (Dose 4)Treatment being tested
Participants will receive a single dose of AZD1043 (Dose 4) or placebo.
Treatment: AZD1043 and Placebo
- Part A1 (Global SAD): Cohort 5 - AZD1043 (Dose 5)Treatment being tested
Participants will receive a single dose of AZD1043 (Dose 5) or placebo.
Treatment: AZD1043 and Placebo
- Part A1 (Global SAD): Cohort 6 - AZD1043 (Dose 6)Treatment being tested
Participants will receive a single dose of AZD1043 (Dose 6) or placebo.
Treatment: AZD1043 and Placebo
- Part A2 (Japanese SAD): Cohort 1 - AZD1043 (Dose X)Treatment being tested
Japanese participants will receive a single dose of AZD1043 or placebo.
Treatment: AZD1043 and Placebo
- Part A2 (Japanese SAD): Cohort 2 - AZD1043 (Dose Y)Treatment being tested
Japanese participants will receive a single dose of AZD1043 or placebo.
Treatment: AZD1043 and Placebo
- Part A3 (Chinese SAD): Cohort 1 - AZD1043 (Dose Z)Treatment being tested
Chinese participants will receive a single dose of AZD1043 or placebo.
Treatment: AZD1043 and Placebo
- Part B1 (Global MAD): Cohort 1 - AZD1043 (Dose A)Treatment being tested
Participants will receive multiple doses of AZD1043 or placebo.
Treatment: AZD1043 and Placebo
- Part B1 (Global MAD): Cohort 2 - AZD1043 (Dose B)Treatment being tested
Participants will receive multiple doses of AZD1043 or placebo.
Treatment: AZD1043 and Placebo
- Part B1 (Global MAD): Cohort 3 - AZD1043 (Dose C)Treatment being tested
Participants will receive multiple doses of AZD1043 or placebo.
Treatment: AZD1043 and Placebo
- Part B2 (Japanese MAD): Cohort 1 - AZD1043 (Dose D)Treatment being tested
Japanese participants will receive multiple doses of AZD1043 or placebo.
Treatment: AZD1043 and Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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.
- Plain-language title
- Early safety study of AZD1043 in adults living with overweight or obesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 10 November 2026.
- Fit questions
- Built from NCT07511205, who can take part
- Record updated
- 9 November 2026