A Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy Participants

An Open-label, Fixed-sequence Study to Assess the Effect of Elecoglipron on the Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Participants

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Atorvastatin; Drug: Elecoglipron; Drug: Rosuvastatin

Detailed Description

This is an open-label, fixed-sequence, conducted at 2 study centers with 2 groups.

Group 1 is designed to assess the PK of atorvastatin in healthy participants when administered alone and in combination with multiple doses of elecoglipron. This group will consist of a screening period, 6 treatment periods, and a follow-up visit. Each participant in Group 1 will be involved in the study for approximately 15 weeks.

Group 2 is designed to assess the PK of rosuvastatin in healthy participants when administered alone and in combination with multiple doses of elecoglipron. This group will consist of a screening period, 5 treatment periods, and a follow-up visit. Each participant in Group 2 will be involved in the study for approximately 16 weeks.

Group 1 and Group 2 are independent and non-sequential parts in this study. All parts of this study will be performed in healthy male and female participants

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Not yet recruiting
      • Research Site
  • Maryland
    • Brooklyn, Maryland, United States, 21225
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Period 1; Participants will receive a single dose of atorvastatin on Day 1.	Drug: Atorvastatin; Atorvastatin will be administered as oral tablet.
Experimental: Group 1: Period 2; Participants will receive single dose of atorvastatin on Day 5 and then receive multiple doses of elecoglipron from Day 7 to Day 40.	Drug: Atorvastatin; Atorvastatin will be administered as oral tablet.; Drug: Elecoglipron; Elecoglipron will be administered as oral tablet.
Experimental: Group 1: Period 3; Participants will receive single dose of atorvastatin on Day 41 and then receive multiple doses of elecoglipron from Day 41 to Day 43.	Drug: Atorvastatin; Atorvastatin will be administered as oral tablet.; Drug: Elecoglipron; Elecoglipron will be administered as oral tablet.
Experimental: Group 1: Period 4; 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.	Drug: Atorvastatin; Atorvastatin will be administered as oral tablet.; Drug: Elecoglipron; Elecoglipron will be administered as oral tablet.
Experimental: Group 1: Period 5; Participants will receive single dose of atorvastatin and elecoglipron on Day 59. Participants will receive elecoglipron alone on Day 60 to Day 61.	Drug: Atorvastatin; Atorvastatin will be administered as oral tablet.; Drug: Elecoglipron; Elecoglipron will be administered as oral tablet.
Experimental: Group 1: Period 6; 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.	Drug: Atorvastatin; Atorvastatin will be administered as oral tablet.; Drug: Elecoglipron; Elecoglipron will be administered as oral tablet.
Experimental: Group 2: Period 1; Participants will receive single dose of rosuvastatin on Day 1 and then multiple doses of elecoglipron from Day 5 to Day 38.	Drug: Elecoglipron; Elecoglipron will be administered as oral tablet.; Drug: Rosuvastatin; Rosuvastatin will be administered as oral tablet.
Experimental: Group 2: Period 2; 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.	Drug: Elecoglipron; Elecoglipron will be administered as oral tablet.; Drug: Rosuvastatin; Rosuvastatin will be administered as oral tablet.
Experimental: Group 2: Period 3; 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.	Drug: Elecoglipron; Elecoglipron will be administered as oral tablet.; Drug: Rosuvastatin; Rosuvastatin will be administered as oral tablet.
Experimental: Group 2: Period 4; 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.	Drug: Elecoglipron; Elecoglipron will be administered as oral tablet.; Drug: Rosuvastatin; Rosuvastatin will be administered as oral tablet.
Experimental: Group 2: Period 5; 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.	Drug: Elecoglipron; Elecoglipron will be administered as oral tablet.; Drug: Rosuvastatin; Rosuvastatin will be administered as oral tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under concentration-time curve from time 0 to infinity (AUCinf) of atorvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.	Group 1: Day 1 to Day 71
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of atorvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.	Group 1: Day 1 to Day 71
Maximum observed drug concentration (Cmax) of atorvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.	Group 1: Day 1 to Day 71
AUCinf of rosuvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.	Group 2: Day 1 to Day 76
AUClast of rosuvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.	Group 2: Day 1 to Day 76
Cmax of rosuvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.	Group 2: Day 1 to Day 76
Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on AUCinf (R AUCinf) of atorvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.	Group 1: Day 1 to Day 71
Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on AUClast (R AUClast) of atorvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.	Group 1: Day 1 to Day 71
Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on Cmax (R Cmax) of atorvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.	Group 1: Day 1 to Day 71
Terminal elimination half-life (t1/2λz) of atorvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.	Group 1: Day 1 to Day 71
Terminal rate constant (λz) of atorvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.	Group 1: Day 1 to Day 71
Time to reach maximum observed concentration (tmax) of atorvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.	Group 1: Day 1 to Day 71
Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on AUCinf (R AUCinf) of rosuvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.	Group 2: Day 1 to Day 76
Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on AUClast (R AUClast) of rosuvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.	Group 2: Day 1 to Day 76
Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on Cmax (R Cmax) of rosuvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.	Group 2: Day 1 to Day 76
t1/2λz of rosuvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.	Group 2: Day 1 to Day 76
λz of rosuvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.	Group 2: Day 1 to Day 76
tmax of rosuvastatin	To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.	Group 2: Day 1 to Day 76

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs) and adverse event of special interest (AESI)	To examine the safety and tolerability of elecoglipron alone and in combination with atorvastatin (Group 1) or rosuvastatin (Group 2) in healthy participants.	Group 1: Day -28 to Day 74; Group 2: Day -28 to Day 79

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2026
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): September 18, 2026

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Type 2 diabetes; Pharmacokinetics; Fixed sequence; Statin exposure
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Azoles; Hydrocarbons; Amides; Pyrimidines; Hydrocarbons, Halogenated; Pyrroles; Heptanoic Acids; Sulfonamides; Sulfones; Fluorobenzenes; Hydrocarbons, Fluorinated; Atorvastatin; Rosuvastatin Calcium
• Other Study ID Numbers: D7260C00028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptriaIs.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/ Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No