A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participants Living With Overweight and/or Obesity.
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.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Both Part A and Part B will comprise of: * Screening period (up to 5 weeks). * Treatment period. * Safety follow-up period."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests AZD1043 in healthy adults living with overweight or obesity, including people of Japanese and Chinese descent. It checks safety, side effects, how the body handles the drug, and how the drug affects the body after one dose or repeated doses at increasing amounts.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- All women must have a negative pregnancy test at screening and when entering the study clinic.
- Women who cannot become pregnant must have confirmed menopause or records of surgery to remove the uterus, both ovaries, or both fallopian tubes.
- You must weigh at least 50 kg (about 110 pounds). Your BMI, a measure of weight compared with height, must be 25–39.9 for the global groups or 23–39.9 for the Japanese and Chinese groups.
- For the Japanese groups (Parts A2 and B2), you must be Japanese, with both parents and all 4 grandparents being Japanese. This includes people born in Japan and Japanese Americans, including second and third generations living outside Japan.
- For the Chinese group (Part A3), both parents and all 4 grandparents must be ethnically Chinese. This includes second and third generations living outside China.
Who can't join
- A history of a major disease or health condition.
- Past or current stomach, bowel, liver, or kidney disease, or another condition that affects how your body takes in, processes, or removes drugs.
- A major illness, medical procedure, surgery, or injury within 4 weeks before the first study dose.
- Important abnormal results on blood or urine tests, or in vital signs such as blood pressure.
- A history of severe allergy, or an ongoing major allergy to drugs similar to AZD1043.
- Use of prescription, over-the-counter, or experimental weight-loss medicines within 3 months before screening.
- A history of psychosis (loss of touch with reality), bipolar disorder (large shifts in mood), or major depression within the past 2 years, with symptoms that are not stable.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 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.
Study sites (2)
CA
- Research Site · Glendale, CA 91206More trials in Glendale
MD
- Research Site · Brooklyn, MD 21225More trials in Brooklyn