NCT07534592

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
5mo left

Started Apr 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

April 10, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 12, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 10, 2026

Last Update Submit

April 10, 2026

Conditions

Healthy Participants

Keywords

PharmacokineticsStatin exposureFixed sequenceType 2 diabetesObesity

Outcome Measures

Primary Outcomes (18)

  • 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 Outcomes (1)

  • Number of participants with adverse events (AEs) and adverse event of special interest (AESI)

    Group 1: Day -28 to Day 74; Group 2: Day -28 to Day 79

Study Arms (11)

Group 1: Period 1

EXPERIMENTAL

Participants will receive a single dose of atorvastatin on Day 1.

Drug: Atorvastatin

Group 1: Period 2

EXPERIMENTAL

Participants will receive single dose of atorvastatin on Day 5 and then receive multiple doses of elecoglipron from Day 7 to Day 40.

Drug: ElecoglipronDrug: Atorvastatin

Group 1: Period 3

EXPERIMENTAL

Participants will receive single dose of atorvastatin on Day 41 and then receive multiple doses of elecoglipron from Day 41 to Day 43.

Drug: ElecoglipronDrug: Atorvastatin

Group 1: Period 4

EXPERIMENTAL

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: ElecoglipronDrug: Atorvastatin

Group 1: Period 5

EXPERIMENTAL

Participants will receive single dose of atorvastatin and elecoglipron on Day 59. Participants will receive elecoglipron alone on Day 60 to Day 61.

Drug: ElecoglipronDrug: Atorvastatin

Group 1: Period 6

EXPERIMENTAL

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: ElecoglipronDrug: Atorvastatin

Group 2: Period 1

EXPERIMENTAL

Participants will receive single dose of rosuvastatin on Day 1 and then multiple doses of elecoglipron from Day 5 to Day 38.

Drug: ElecoglipronDrug: Rosuvastatin

Group 2: Period 2

EXPERIMENTAL

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: ElecoglipronDrug: Rosuvastatin

Group 2: Period 3

EXPERIMENTAL

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: ElecoglipronDrug: Rosuvastatin

Group 2: Period 4

EXPERIMENTAL

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: ElecoglipronDrug: Rosuvastatin

Group 2: Period 5

EXPERIMENTAL

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: ElecoglipronDrug: Rosuvastatin

Interventions

ElecoglipronDRUG

Elecoglipron will be administered as oral tablet.

Group 1: Period 2Group 1: Period 3Group 1: Period 4Group 1: Period 5Group 1: Period 6Group 2: Period 1Group 2: Period 2Group 2: Period 3Group 2: Period 4Group 2: Period 5
AtorvastatinDRUG

Atorvastatin will be administered as oral tablet.

Group 1: Period 1Group 1: Period 2Group 1: Period 3Group 1: Period 4Group 1: Period 5Group 1: Period 6
RosuvastatinDRUG

Rosuvastatin will be administered as oral tablet.

Group 2: Period 1Group 2: Period 2Group 2: Period 3Group 2: Period 4Group 2: Period 5

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Glendale, California, 91206, United States

Location

Research Site

Brooklyn, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Interventions

AtorvastatinRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 16, 2026

Study Start

April 12, 2026

Primary Completion (Estimated)

September 11, 2026

Study Completion (Estimated)

September 11, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

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
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
More information

Locations

US(2)