Elecoglipron with Statins for Healthy Subjects
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive atorvastatin or rosuvastatin alone and in combination with elecoglipron across multiple treatment periods
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants will receive a single dose of rosuvastatin in the morning on Day 106.
Participants will receive elecoglipron and a single dose of rosuvastatin in the morning on Day 87. Participants will continue elecoglipron from Day 87 to Day 91.
Participants will receive elecoglipron in the morning and a single dose of rosuvastatin in the evening on Day 66. Participant will continue on elecoglipron alone from Day 67 to Day 69 and from Day 73 to Day 86.
Participants will receive elecoglipron in the morning along with a single dose of rosuvastatin on Day 60. Participant will continue elecoglipron alone from Day 61 to Day 65.
Participants will receive elecoglipron in the morning and a single dose of rosuvastatin in the evening on Day 45. Participant will continue on different doses of elecoglipron alone from Day 46 to Day 59.
Participants will receive elecoglipron in the morning along with a single dose of rosuvastatin on Day 39. Participant will continue elecoglipron alone from Day 40 to Day 44.
Participants will receive single dose of rosuvastatin on Day 1 and then multiple doses of elecoglipron from Day 5 to Day 38.
Participants will receive elecoglipron in the morning and a single dose of atorvastatin in the evening on Day 62. Participant will continue elecoglipron alone from Day 63 to Day 64.
Participants will receive single dose of atorvastatin and elecoglipron on Day 59. Participants will receive elecoglipron alone on Day 60 to Day 61.
Participants will receive elecoglipron in the morning and a single dose of atorvastatin in the evening on Day 44. Participant will continue elecoglipron on Day 45. Participants will receive daily administration of different doses of elecoglipron alone from Day 46 to Day 58.
Participants will receive single dose of atorvastatin on Day 41 and then receive multiple doses of elecoglipron from Day 41 to Day 43.
Participants will receive single dose of atorvastatin on Day 5 and then receive multiple doses of elecoglipron from Day 7 to Day 40.
Participants will receive a single dose of atorvastatin on Day 1.
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
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%, ...
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 - ...
3.
revitalizinghealthwellness.com
revitalizinghealthwellness.com/blog/statins-glp-1s-and-hormone-health-what-small-details-may-be-quietly-impacting-your-metabolism/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 ( ...
5.
realclearscience.com
realclearscience.com/blog/2024/07/17/are_glp-1_weight_loss_drugs_the_new_statins_or_are_they_even_better_1044680.htmlAre 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 ...
6.
trial.medpath.com
trial.medpath.com/news/8021e3c1b6c62635/eccogene-reports-positive-phase-1b-results-for-oral-glp-1-agonist-elecoglipron-in-chinese-patients-with-obesityEccogene 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 ...
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 ...
10.
fiercebiotech.com
fiercebiotech.com/biotech/astrazeneca-reveals-oral-glp1-scored-phase-2-wins-holds-back-weight-loss-dataAstraZeneca'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 ...
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.