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Elecoglipron

Phase 1

Healthy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: May 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07534592A Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy ParticipantsPHASE1 RECRUITING 40Apr 16, 2026Sep 18, 2026May 12, 20262 United States
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Study Endpoints
Primary Endpoints
Area under concentration-time curve from time 0 to infinity (AUCinf) of atorvastatin
Group 1: Day 1 to Day 71

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of atorvastatin
Group 1: Day 1 to Day 71

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

Maximum observed drug concentration (Cmax) of atorvastatin
Group 1: Day 1 to Day 71

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

AUCinf of rosuvastatin
Group 2: Day 1 to Day 76

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

AUClast of rosuvastatin
Group 2: Day 1 to Day 76

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

Cmax of rosuvastatin
Group 2: Day 1 to Day 76

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on AUCinf (R AUCinf) of atorvastatin
Group 1: Day 1 to Day 71

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on AUClast (R AUClast) of atorvastatin
Group 1: Day 1 to Day 71

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on Cmax (R Cmax) of atorvastatin
Group 1: Day 1 to Day 71

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

Terminal elimination half-life (t1/2λz) of atorvastatin
Group 1: Day 1 to Day 71

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

Terminal rate constant (λz) of atorvastatin
Group 1: Day 1 to Day 71

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

Time to reach maximum observed concentration (tmax) of atorvastatin
Group 1: Day 1 to Day 71

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on AUCinf (R AUCinf) of rosuvastatin
Group 2: Day 1 to Day 76

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on AUClast (R AUClast) of rosuvastatin
Group 2: Day 1 to Day 76

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on Cmax (R Cmax) of rosuvastatin
Group 2: Day 1 to Day 76

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

t1/2λz of rosuvastatin
Group 2: Day 1 to Day 76

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

λz of rosuvastatin
Group 2: Day 1 to Day 76

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

tmax of rosuvastatin
Group 2: Day 1 to Day 76

To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

Secondary Endpoints
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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1: Period 1EXPERIMENTALParticipants will receive a single dose of atorvastatin on Day 1.
Group 1: Period 2EXPERIMENTALParticipants will receive single dose of atorvastatin on Day 5 and then receive multiple doses of elecoglipron from Day 7 to Day 40.
Group 1: Period 3EXPERIMENTALParticipants will receive single dose of atorvastatin on Day 41 and then receive multiple doses of elecoglipron from Day 41 to Day 43.
Group 1: Period 4EXPERIMENTALParticipants 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.
Group 1: Period 5EXPERIMENTALParticipants will receive single dose of atorvastatin and elecoglipron on Day 59. Participants will receive elecoglipron alone on Day 60 to Day 61.
Group 1: Period 6EXPERIMENTALParticipants 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.
Group 2: Period 1EXPERIMENTALParticipants will receive single dose of rosuvastatin on Day 1 and then multiple doses of elecoglipron from Day 5 to Day 38.
Group 2: Period 2EXPERIMENTALParticipants 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.
Group 2: Period 3EXPERIMENTALParticipants 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.
Group 2: Period 4EXPERIMENTALParticipants 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.
Group 2: Period 5EXPERIMENTALParticipants 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.
Interventions
NameTypeDescription
ElecoglipronDRUGElecoglipron will be administered as oral tablet.
AtorvastatinDRUGAtorvastatin will be administered as oral tablet.
RosuvastatinDRUGRosuvastatin will be administered as oral tablet.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

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 througho...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07534592studyFirstPostDate: changed
LOWMay 21, 2026NCT07534592NEW_TRIAL: changed
LOWMay 21, 2026NCT07534592NEW_TRIAL: changed