A Study to Investigate the Effect of AZD0780 on Metformin Pharmacokinetics in Healthy Adult Volun… (NCT07216131) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Effect of AZD0780 on Metformin Pharmacokinetics in Healthy Adult Volunteers Aged 18 to 55 Years
United States14 participantsStarted 2025-11-10
Plain-language summary
The purpose of this study is to determine how the experimental medication AZD0780 impacts the pharmacokinetics (PK) of metformin, a common medication used to treat type 2 diabetes mellitus, when given together in healthy participants.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have a body mass index (BMI) between 18 and 35 kilograms per meter squared (kg/m2) inclusive and weigh at least 50 kilograms (kg) at the Screening Visit.
* Participants agree to follow study specific contraceptive requirements.
* Have suitable veins for cannulation or repeated venipuncture.
Exclusion Criteria:
* History of any clinically important disease or disorder which may put the participant at risk because of participation in the study or influence the results.
* Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
* 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, or history of hypersensitivity to drugs with a similar chemical structure or class to metformin or AZD0780.
* Treatment with any lipid lowering therapy or AZD0780 within the 3 months prior to the Screening Visit.
* Treatment with drugs for reduction or inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) within the last 12 months prior to the Screening Visit (approved or investigational and apart from AZD0780).
* Current or previous administration of inclisiran.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under concentration time curve from time 0 to infinity (AUCinf)
Timeframe: Days 1 to 3 and Days 8 to 10
2
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)