AZD9550 for Fatty Liver Disease
(CONTEMPO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new treatment called AZD9550 for NASH, a liver disease often found in individuals who are overweight or obese, with or without type 2 diabetes. Researchers aim to assess the safety of AZD9550, its tolerability, and how the body processes it. Individuals who are overweight or obese and have type 2 diabetes managed by diet, metformin, or up to two other stable treatments might be suitable for this study. As a Phase 1 trial, participants could be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I need to stop my current medications to join the trial?
If you are taking certain oral anti-diabetic medications, you may need to stop them for a 4-week period or longer before joining the trial. The protocol does not specify other medication restrictions, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that AZD9550 is being tested for safety and tolerability in treating a liver disease called NASH. Studies have indicated that patients can take AZD9550 without major problems. As the treatment is in the early testing stages, researchers are still learning about its effects on people. These initial tests primarily focus on identifying side effects and understanding how the body processes the medicine.
AZD9550 is being studied in individuals who are overweight or obese, with or without type 2 diabetes. So far, these studies have reported no major safety concerns. This is encouraging, but since the treatment is still under investigation, not all potential effects are known. Prospective trial participants should consider this and discuss it with their doctor.12345Why do researchers think this study treatment might be promising?
Researchers are excited about AZD9550 for fatty liver disease because it offers a novel approach by potentially addressing both fatty liver and type 2 diabetes (T2DM) in overweight or obese patients. Unlike standard treatments like lifestyle changes or medications targeting only liver fat reduction, AZD9550 is being explored for its ability to be titrated bi-weekly or monthly, which might offer more personalized and adaptive dosing. This could lead to more effective and sustained management of the condition, especially in diverse populations, including Japanese participants with T2DM. Additionally, its subcutaneous administration may provide a more convenient alternative to oral medications or invasive procedures, enhancing patient adherence and outcomes.
What evidence suggests that AZD9550 might be an effective treatment for NASH?
Research shows that AZD9550, which participants in this trial may receive, could be a promising treatment for NASH, a type of liver disease. Earlier studies suggest that this treatment might help reduce liver fat and improve liver health. AZD9550 belongs to a group of drugs known as GLP-1 receptor agonists, which have been shown to help liver conditions by reducing fat and inflammation. Although specific data on AZD9550 remains limited, its mechanism targets known causes of liver disease, offering hope for an effective treatment. Early results are promising, but more research is needed to confirm these effects.13456
Are You a Good Fit for This Trial?
This trial is for overweight or obese adults aged 18-65, with or without Type 2 Diabetes (T2DM). Participants must be able to self-administer injections, have a Body Mass Index (BMI) of ≥27 to ≤39.9 kg/m^2, and maintain contraceptive use. Those with T2DM should manage glucose control through diet/metformin and possibly one other treatment.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive multiple ascending doses of AZD9550 or placebo, with bi-weekly/monthly up-titration for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD9550
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