AZD0780 with Metformin for Healthy Subjects

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Lipid-lowering, PCSK9 inhibitors, Inclisiran

Disqualifiers: Hepatitis, HIV, Severe allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

14 Participants Needed

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.

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

My veins are suitable for repeated needle insertions.

My BMI is between 18 and 35, and I weigh at least 50 kg.

I agree to follow the study's birth control requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment Period 1

Participants receive a single dose of metformin followed by a 7-day washout period

8 days

Resident at Clinical Unit

Treatment Period 2

Participants receive a single dose of AZD0780 followed by a single dose of metformin

3 days

Resident at Clinical Unit

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 8 days

Final follow-up visit

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?

Group I: Metformin/Metformin + AZD0780 Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

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

Trials

322

Recruited

137,000+

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07216131

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 ...

2. patlynk.com patlynk.com/trial/NCT07216131

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, ...

3. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-a-study-to-investigate-the-effect-of-azd0780-on-metformin-pharmacokinetics-in-healthy-adult-volunteers-aged-18-to-55-years/555766719

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.

4. astrazeneca.com astrazeneca.com/content/az-us/media/press-releases/2025/AZD0780-a-novel-oral-PCSK9-inhibitor-demonstrated-significant-LDL-cholesterol-LDL-C-reduction-in-PURSUIT-Phase-IIb-trial.html

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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40388602/

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, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05384262

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-pharmacokinetics

AstraZeneca'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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12637960/

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.