Elecoglipron with Statins for Healthy Subjects

Not currently recruiting at 1 trial location
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: AstraZeneca
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the drug elecoglipron interacts with popular cholesterol-lowering medications called statins, specifically atorvastatin and rosuvastatin. Researchers aim to understand these interactions to ensure safety and effectiveness. The study includes two groups: one focuses on atorvastatin, and the other on rosuvastatin. Healthy individuals without significant health issues like heart disease or diabetes, and who are not currently using statins, might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new drug.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that participants should not have been on statin treatment for 4 weeks before the study. 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 has shown that elecoglipron is generally well-tolerated. In a study with 45 Chinese adults with obesity, elecoglipron demonstrated a safety profile similar to other medications in its class, known as GLP-1 receptor agonists. Specifically, it did not cause many serious side effects and was manageable for most participants. The study reported no major adverse events, indicating that elecoglipron is relatively safe for humans so far. However, this conclusion is based on early research, and further studies are necessary to fully understand its safety across different populations.12345

Why are researchers excited about this trial's treatments?

Elecoglipron is unique because it targets glucose regulation differently than traditional statins, such as atorvastatin and rosuvastatin, which primarily focus on lowering cholesterol levels. Researchers are excited about elecoglipron because it represents a new class of medication that could potentially offer benefits beyond cholesterol management, particularly in metabolic health. This treatment may provide a dual action by impacting both glucose and lipid metabolism, offering a fresh approach to managing cardiovascular risk factors.

What evidence suggests that this trial's treatments could be effective?

Research has shown that statins, such as atorvastatin and rosuvastatin, effectively lower bad cholesterol (LDL) levels. Specifically, rosuvastatin reduced LDL more than a placebo in studies. Elecoglipron, a different type of drug, aids in weight loss and reduces heart disease risks. Some studies suggest that statins might alter the effectiveness of these weight-loss drugs. In this trial, participants will receive either atorvastatin or rosuvastatin combined with elecoglipron to explore how these treatments might work together in managing weight and improving heart health.678910

Are You a Good Fit for This Trial?

This trial is for healthy adults who are not pregnant or breastfeeding and can use effective birth control. People with diabetes, heart disease, serious allergies to similar drugs, recent major illness or surgery, abnormal lab results, or certain digestive issues cannot participate.

Inclusion Criteria

I use birth control if I am a sexually active man with a partner who can get pregnant.
I am postmenopausal or have had surgery that permanently prevents pregnancy.
I am not breastfeeding and will use effective birth control during the study.
See 1 more

Exclusion Criteria

I have had pancreatitis or digestive issues that affect how my body handles medicine.
I have had a serious disease or medical condition in the past.
Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive atorvastatin or rosuvastatin alone and in combination with elecoglipron across multiple treatment periods

11 weeks
Multiple visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Elecoglipron

Trial Overview

The study tests how a new drug called elecoglipron affects the way the body processes two cholesterol-lowering medications—atorvastatin and rosuvastatin—in healthy volunteers. Participants are randomly assigned to receive combinations of these medicines.

How Is the Trial Designed?

13

Treatment groups

Experimental Treatment

Group I: Group 2: Period 7Experimental Treatment1 Intervention
Group II: Group 2: Period 6Experimental Treatment2 Interventions
Group III: Group 2: Period 5Experimental Treatment2 Interventions
Group IV: Group 2: Period 4Experimental Treatment2 Interventions
Group V: Group 2: Period 3Experimental Treatment2 Interventions
Group VI: Group 2: Period 2Experimental Treatment2 Interventions
Group VII: Group 2: Period 1Experimental Treatment2 Interventions
Group VIII: Group 1: Period 6Experimental Treatment2 Interventions
Group IX: Group 1: Period 5Experimental Treatment2 Interventions
Group X: Group 1: Period 4Experimental Treatment2 Interventions
Group XI: Group 1: Period 3Experimental Treatment2 Interventions
Group XII: Group 1: Period 2Experimental Treatment2 Interventions
Group XIII: Group 1: Period 1Experimental Treatment1 Intervention

Find a Clinic Near You

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 profile image

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 profile image

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

Efficacy, effectiveness and real life goal attainment of statins in ...

The meta-analysis showed that 40 mg of fluvastatin reduced LDL cholesterol on average by 27%, pravastatin by 29%, lovastatin and simvastatin by 37%, ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35331984/

Comparative effectiveness of statins on non-high density ...

Compared with placebo, the greatest reductions in levels of non-HDL-C were seen with rosuvastatin at high (-2.31 mmol/L, 95% credible interval - ...

Statins, GLP-1s, and Hormone Health: What Small Details ...

The implication: taking statins might blunt or reduce the effectiveness of GLP-1–based therapies. Why This Matters for You (Especially If ...

NCT07534592 | A Study to Investigate the Effect of ...

The study has 2 groups, one each focusing on co-administration of elecoglipron and atorvastatin or rosuvastatin to assess the pharmacokinetics ( ...

Are GLP-1 Weight Loss Drugs the New Statins? Or Are ...

Two large studies showed that the drugs greatly reduce the risk of major cardiovascular events – by 26% for those with diabetes and 20% for ...

Eccogene Reports Positive Phase 1b Results for Oral GLP-1 ...

Elecoglipron demonstrated a favorable safety and tolerability profile consistent with the GLP-1 receptor agonist class in 45 Chinese adults with obesity or ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37852529/

Safety and efficacy of the new, oral, small-molecule, GLP-1 ...

Preliminary evidence supports that orforglipron and danuglipron are efficient in glycemic control and weight reduction in T2DM, obesity or both.

Effects of AZD5004 in adults who are living with obesity ...

A Phase IIb randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in participants living with obesity ...

elecoglipron (AZD5004) / Eccogene, AstraZeneca

- "Elecoglipron was generally well-tolerated, with a safety profile consistent with the GLP-1RA class...The PK profile of elecoglipron in Chinese ...

AstraZeneca's oral GLP-1 scored phase 2 wins, but no data ...

The Vista study, which wrapped up in November, assessed weight loss of elecoglipron versus placebo over 36 weeks among 310 patients with obesity ...