AZD1043 for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new treatment called AZD1043 to assess its safety and behavior in the body for individuals with overweight or obesity. Researchers aim to understand how the body processes the drug and identify any side effects. Participants will receive either a single or multiple doses of AZD1043 or a placebo (a harmless pill with no effect) for comparison. The study is open to healthy adults with a body mass index (BMI) between 25 and 39.9 who have not recently taken weight loss medications. Individuals of Japanese and Chinese descent are especially encouraged to join certain parts of the trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot have taken any weight loss medications in the last 3 months before the screening.
Is there any evidence suggesting that AZD1043 is likely to be safe for humans?
Research shows that AZD1043 is being tested for safety and tolerance in people who are overweight or obese. Since this study is in the early stages, it primarily assesses how well adults handle the treatment. This phase is crucial for identifying any potential side effects, though detailed safety information is still being gathered. So far, no specific negative effects have been widely reported. However, researchers aim to closely monitor participants to quickly identify and manage any reactions. This approach enhances understanding of the treatment's safety as further studies are conducted.12345
Why do researchers think this study treatment might be promising for obesity?
AZD1043 is unique because it offers a fresh approach to tackling obesity by potentially targeting different pathways than existing treatments. Most current obesity treatments focus on appetite suppression or calorie absorption reduction, but AZD1043 may work by directly influencing metabolic processes, which could lead to more effective weight management. Researchers are excited about this treatment because it could provide quicker and more sustainable results with fewer side effects, offering a promising alternative to traditional options like orlistat or phentermine.
What evidence suggests that AZD1043 might be an effective treatment for obesity?
Research has shown that AZD1043 might help people with obesity lose body fat. In this trial, participants will receive varying dosages of AZD1043 or a placebo. One study found that a specific dosage led to a loss of more than 5% of body fat while maintaining muscle loss below 0.5%. This indicates that participants primarily lost fat while preserving muscle. These early results are promising, but further research is needed to confirm its effectiveness.12367
Are You a Good Fit for This Trial?
This trial is for healthy adults who are overweight or have obesity (BMI between 25–39.9, or slightly lower for Japanese/Chinese participants), weigh at least 50 kg, and meet specific ancestry requirements if joining the Japanese or Chinese groups. Women must not be pregnant and some must show proof they can't become pregnant.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single or multiple ascending doses of AZD1043 or placebo
Safety Follow-up
Participants are monitored for safety and tolerability after receiving AZD1043
What Are the Treatments Tested in This Trial?
Interventions
- AZD1043
Trial Overview
The study tests different doses of a new drug called AZD1043 compared to a placebo in healthy overweight or obese adults, including those of Japanese and Chinese descent. The main goal is to see how safe the drug is and how it behaves in the body after single and multiple doses.
How Is the Trial Designed?
13
Treatment groups
Experimental Treatment
Japanese participants will receive multiple doses of AZD1043 or placebo.
Participants will receive multiple doses of AZD1043 or placebo.
Participants will receive multiple doses of AZD1043 or placebo.
Participants will receive multiple doses of AZD1043 or placebo.
Chinese participants will receive a single dose of AZD1043 or placebo.
Japanese participants will receive a single dose of AZD1043 or placebo.
Japanese participants will receive a single dose of AZD1043 or placebo.
Participants will receive a single dose of AZD1043 (Dose 6) or placebo.
Participants will receive a single dose of AZD1043 (Dose 5) or placebo.
Participants will receive a single dose of AZD1043 (Dose 4) or placebo.
Participants will receive a single dose of AZD1043 (Dose 3) or placebo.
Participants will receive a single dose of AZD1043 (Dose 2) or placebo.
Participants will receive a single dose of AZD1043 (Dose 1) or placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Parexel
Industry Sponsor
Peyton Howell
Parexel
Chief Executive Officer
Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois
Dr. Austin Smith
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland
Citations
NCT07511205 | A Study to Investigate Safety, Tolerability ...
The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single and multiple ...
AZD1043 for Obesity · Recruiting Participants for Phase ...
The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single ...
3.
allclinicaltrials.com
allclinicaltrials.com/study/NCT07511205?searchMetadata=eyJzdGF0ZSI6ImNhbGlmb3JuaWEiLCJjaXR5IjoiZ2xlbmRhbGUiLCJzZWFyY2hDYXJkUG9zaXRpb24iOjh9AZD1043 - A Study to Investigate Safety, Tolerability ...
The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single ...
4.
astrazeneca.com
astrazeneca.com/content/dam/az/PDF/2026/eq1/Q1-2026-results-clinical-trials-appendix.pdfClinical Trials Appendix - Q1 2026 Results Update
• Data readout: Q1 2026. • Primary endpoint met. Phase IIb. VISTA. NCT06579092. Obesity or overweight who have at least one weight- related ...
5.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-investigate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-azd1043-in-heaA Study to Investigate Safety, Tolerability, Pharmacokinetics ...
The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single ...
A Phase I, Randomized, Single-blind, Placebo-controlled ...
The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single ...
Effects of AZD5004 in adults who are living with obesity ...
A Phase IIb randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in participants living with obesity ...
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