A Phase 1 interventional study of Elecoglipron and Atorvastatin in Healthy Participants, sponsored by AstraZeneca. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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.
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, 7 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
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 48 is below the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a single dose of atorvastatin on Day 1.
Drug: Atorvastatin
Participants will receive single dose of atorvastatin on Day 5 and then receive multiple doses of elecoglipron from Day 7 to Day 40.
Drug: Elecoglipron · Drug: Atorvastatin
Participants will receive single dose of atorvastatin on Day 41 and then receive multiple doses of elecoglipron from Day 41 to Day 43.
Drug: Elecoglipron · Drug: Atorvastatin
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: Elecoglipron · Drug: Atorvastatin
Participants will receive single dose of atorvastatin and elecoglipron on Day 59. Participants will receive elecoglipron alone on Day 60 to Day 61.
Drug: Elecoglipron · Drug: Atorvastatin
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: Elecoglipron · Drug: Atorvastatin
Participants will receive single dose of rosuvastatin on Day 1 and then multiple doses of elecoglipron from Day 5 to Day 38.
Drug: Elecoglipron · Drug: Rosuvastatin
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 · Drug: Rosuvastatin
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 · Drug: Rosuvastatin
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 · Drug: Rosuvastatin
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.
Drug: Elecoglipron · Drug: Rosuvastatin
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.
Drug: Elecoglipron · Drug: Rosuvastatin
Participants will receive a single dose of rosuvastatin in the morning on Day 106.
Drug: Rosuvastatin
Elecoglipron will be administered as oral tablet.
Atorvastatin will be administered as oral tablet.
Rosuvastatin will be administered as oral tablet.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Group 2: Day 1 to Day 76
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.
Time frame: Group 1: Day -28 to Day 74; Group 2: Day -28 to Day 79
Plan to share: Yes — 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.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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