How elecoglipron changes atorvastatin and rosuvastatin levels in healthy adults
An Open-label, Fixed-sequence Study to Assess the Effect of Elecoglipron on the Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Participants
This test will see if taking elecoglipron changes how atorvastatin or rosuvastatin are absorbed and cleared in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 2 sites (Glendale, California and 1 other locations) |
| Trial ID | NCT07534592 on ClinicalTrials.gov |
What this trial studies
This open-label, fixed-sequence Phase 1 pharmacokinetic study enrolls healthy adult volunteers in two independent groups to examine drug-drug interactions between multiple doses of elecoglipron and a single dose of either atorvastatin or rosuvastatin. Group 1 includes six treatment periods over about 15 weeks to compare atorvastatin PK alone and with elecoglipron, while Group 2 includes five treatment periods over about 16 weeks for rosuvastatin. Serial blood sampling will measure drug exposure at prespecified time points, and safety and tolerability will be monitored throughout. The study is conducted at two US clinical research sites with screening and follow-up visits for all participants.
Who should consider this trial
Good fit: Healthy adult men and women who are not pregnant or breastfeeding, have no significant medical conditions, and agree to contraception and study procedures are appropriate candidates.
Not a fit: People with cardiovascular disease, diabetes, neuromuscular or neurogenic disorders, HIV, uncontrolled thyroid disease, or those on chronic statin therapy are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If no clinically important interaction is found, the results could support safe co-prescribing and dosing guidance when elecoglipron is used with atorvastatin or rosuvastatin.
How similar studies have performed: Fixed-sequence PK interaction studies are commonly used and have identified meaningful statin interactions with other drugs, although interaction effects with GLP-1–related agents have varied by compound.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit. * Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception throughout the study. * Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion at screening visit. * Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods. Exclusion Criteria: * History of any clinically important disease or disorder. * Participants with cardiovascular diseases, neuromuscular or neurogenic disease, type 1 or type 2 diabetes mellitus, or positive for human immunodeficiency virus (HIV), or uncontrolled thyroid disease. * History of acute pancreatitis, history or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract. * Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention. * Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs. * Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram at screening. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to elecoglipron or paracetamol. * Participants who have previously received elecoglipron within the last 6 months or was on statin treatment for ≤ 4 weeks prior to the study treatment.
Where this trial is running
Glendale, California and 1 other locations
- Research Site — Glendale, California, United States (Not_yet_recruiting)
- Research Site — Brooklyn, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.