Completed

Effect of AZD0780 on Metformin Pharmacokinetics in Healthy Volunteers

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Study Aim

This study aims to evaluate how the drug AZD0780 affects the body's processing of metformin in healthy volunteers.

What is being tested

AZD0780

+ Metformin

Drug
Who is being recruted

Metabolic Diseases+1

+ Nutritional and Metabolic Diseases

+ Dyslipidemias

From 18 to 55 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 10, 2025

Actual date on which the first participant was enrolled.

This clinical trial aims to study how the drug AZD0780 affects the way the body processes another medication called metformin, which is commonly used to manage blood sugar levels. The study involves healthy male and female participants to understand potential interactions between these two drugs. This research is important because it can provide valuable information about whether AZD0780 changes how metformin works, which could influence future treatments involving these medications. Participants in this study will go through a screening process lasting up to 28 days to ensure they are suitable for the trial. Then, they will spend time living at the clinical unit during two treatment periods, where they will first receive metformin alone and then in combination with AZD0780. The study will observe how the body absorbs, distributes, and eliminates metformin in both scenarios. This trial will help determine if there are any significant changes in the drug's behavior when taken with AZD0780, without specifically mentioning risks or benefits.

Official TitleA Fixed-sequence, Open-label Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Metformin in Healthy Volunteers
NCT07216131
Principal SponsorAstraZeneca
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Metabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism Disorders

Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Research Site

Brooklyn, United StatesOpen Research Site in Google Maps
CompletedOne Study Center