AZD0780 with Metformin for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how AZD0780 affects the body's processing of metformin, a common type 2 diabetes medication, in healthy individuals. Researchers aim to determine if combining these medications alters metformin's function in the body. Participants will first take metformin alone, followed by a combination with AZD0780 after a short break. The study seeks healthy individuals with a specific body weight and no history of major health issues or allergies to the study drugs. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.
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 lipid-lowering therapy or AZD0780 in the last 3 months, or PCSK9 inhibitors in the last 12 months.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that AZD0780 has been tested for safety and tolerability. Earlier studies suggest that most people did not experience serious side effects when taking it, whether in single or multiple doses. Metformin, a well-known drug for treating type 2 diabetes, is generally safe for most adults.
Since this trial is in its early stages, the main goal is to assess the safety of AZD0780 when used with metformin. Researchers will closely monitor participants for any side effects. While specific results from this trial are not yet available, earlier studies provide some reassurance about the safety of AZD0780.12345Why do researchers think this study treatment might be promising?
AZD0780 is unique because it represents a new approach to enhancing the effects of metformin, a common treatment for managing blood sugar levels. Researchers are excited about AZD0780 because it could potentially improve how metformin works by targeting specific pathways that might help the body respond better to the treatment. This combination could lead to more effective blood sugar control with possibly fewer side effects, offering a promising alternative to those who rely on metformin for managing their condition.
What evidence suggests that AZD0780 might be an effective treatment for type 2 diabetes?
Research has shown that AZD0780, a new medication, can help lower LDL cholesterol, often called "bad" cholesterol. This trial studies how AZD0780 interacts with metformin, a common diabetes medication. Participants will first receive metformin alone, then in combination with AZD0780, to understand how AZD0780 affects the body's processing of metformin. Although specific information about this combination in humans remains limited, AZD0780 has shown promise in managing cholesterol levels, which might indirectly benefit those with diabetes-related conditions.12678
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 to 55 with a BMI between 18 and 35 kg/m2, weighing at least 50 kg. Participants must have suitable veins for blood draws and agree to follow study-specific contraceptive guidelines.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive a single dose of metformin followed by a 7-day washout period
Treatment Period 2
Participants receive a single dose of AZD0780 followed by a single dose of metformin
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD0780
Trial Overview
The study investigates how AZD0780 affects the body's handling of metformin, a drug commonly used for type 2 diabetes. It aims to understand any changes in metformin levels when both drugs are taken by healthy individuals.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive a single dose of metformin on Day 1 in Treatment Period 1 followed by a washout period of 7 days. In Treatment Period 2, participants will receive a single dose of AZD0780 followed by a single dose of metformin on Day 8.
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
A Study to Investigate the Effect of AZD0780 on Metformin ...
Study Overview. The purpose of this study is to determine how the experimental medication AZD0780 impacts the pharmacokinetics (PK) of metformin, a common ...
Effect of AZD0780 on Metformin Pharmacokinetics in ...
This clinical trial aims to study how the drug AZD0780 affects the way the body processes another medication called metformin, ...
Clinical Trial: A Study to Investigate the Effect of AZD0780 ...
Clinical Trial: A Study to Investigate the Effect of AZD0780 on Metformin Pharmacokinetics in Healthy Adult Volunteers Aged 18 to 55 Years.
AZD0780, a novel oral PCSK9 inhibitor, demonstrated ...
AZD0780 is an investigational once-daily oral PCSK9 inhibitor for patients currently not reaching their LDL-C lowering goal despite standard-of-care-lipid ...
Comparative Effectiveness of Metformin Versus Sulfonylureas ...
The adjusted risk of death before age 90 was 30% lower for initiation of metformin monotherapy versus sulfonylurea monotherapy (hazard ratio, ...
NCT05384262 | A Study to Assess the Safety, Tolerability ...
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD0780 following single and multiple dose administration ...
7.
tipranks.com
tipranks.com/news/company-announcements/astrazenecas-new-study-impact-of-azd0780-on-metformin-pharmacokineticsAstraZeneca's New Study: Impact of AZD0780 on ...
The primary goal is to understand how AZD0780 affects the pharmacokinetics of metformin, a widely used diabetes medication, when both are ...
Safety profile of metformin in adolescents with type 2 diabetes
Although metformin is the first-line medicine for type 2 diabetes (T2D), its safety profile in adolescents remains poorly understood.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.