Healthy ParticipantsPhase 1NCT07534592
A Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy Participants
A Phase 1 study testing Elecoglipron, Atorvastatin and Rosuvastatin in people with Healthy Participants, run by AstraZeneca at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Elecoglipron, Atorvastatin and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Apr 2026to 1 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Brooklyn, Maryland, 21225
Research Site
Glendale, California, 91206
About this study
Official title: 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.
Read the 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, 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
- Conditions
- Healthy Participants
- Being tested
- Elecoglipron, Atorvastatin, Rosuvastatin
- Keywords
- Pharmacokinetics, Statin exposure, Fixed sequence, Type 2 diabetes, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElecoglipronDrug
Elecoglipron will be administered as oral tablet.
AtorvastatinDrug
Atorvastatin will be administered as oral tablet.
RosuvastatinDrug
Rosuvastatin will be administered as oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Period 1 | Experimental | Participants will receive a single dose of atorvastatin on Day 1. Receives: 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. Receives: Drug: Elecoglipron; Drug: 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. Receives: Drug: Elecoglipron; Drug: 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. Receives: Drug: Elecoglipron; Drug: 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. Receives: Drug: Elecoglipron; Drug: 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. Receives: Drug: Elecoglipron; Drug: 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. Receives: Drug: Elecoglipron; Drug: 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. Receives: Drug: Elecoglipron; Drug: 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. Receives: Drug: Elecoglipron; Drug: 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. Receives: Drug: Elecoglipron; Drug: 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 and from Day 73 to Day 86. Receives: Drug: Elecoglipron; Drug: Rosuvastatin |
| Group 2: Period 6 | Experimental | 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. Receives: Drug: Elecoglipron; Drug: Rosuvastatin |
| Group 2: Period 7 | Experimental | Participants will receive a single dose of rosuvastatin in the morning on Day 106. Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Group 2: Day 1 to Day 76
Secondary outcomes (1)
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.
Measured: Group 1: Day -28 to Day 74; Group 2: Day -28 to Day 79
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start16 Apr 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534592
- Sponsor's protocol ID
- D7260C00028
- Status last verified
- Aug 2026
- First submitted
- 10 Apr 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed-sequence Study to Assess the Effect of Elecoglipron on the Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Participants
- ClinicalTrials.gov ID
- NCT07534592
- Acronym / sponsor ID
- D7260C00028
- Conditions
- Healthy Participants
- Keywords
- Pharmacokinetics, Statin exposure, Fixed sequence, Type 2 diabetes, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Group 1: Period 1 | Experimental | Drug: AtorvastatinParticipants will receive a single dose of atorvastatin on Day 1. |
| Group 1: Period 2 | Experimental | Drug: Elecoglipron, Drug: AtorvastatinParticipants 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 3 | Experimental | Drug: Elecoglipron, Drug: AtorvastatinParticipants 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 4 | Experimental | Drug: Elecoglipron, Drug: AtorvastatinParticipants 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 5 | Experimental | Drug: Elecoglipron, Drug: AtorvastatinParticipants 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 6 | Experimental | Drug: Elecoglipron, Drug: AtorvastatinParticipants 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 1 | Experimental | Drug: Elecoglipron, Drug: RosuvastatinParticipants will receive single dose of rosuvastatin on Day 1 and then multiple doses of elecoglipron from Day 5 to Day 38. |
| Group 2: Period 2 | Experimental | Drug: Elecoglipron, Drug: RosuvastatinParticipants 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 3 | Experimental | Drug: Elecoglipron, Drug: RosuvastatinParticipants 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 4 | Experimental | Drug: Elecoglipron, Drug: RosuvastatinParticipants 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 5 | Experimental | Drug: Elecoglipron, Drug: RosuvastatinParticipants 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. |
| Group 2: Period 6 | Experimental | Drug: Elecoglipron, Drug: RosuvastatinParticipants 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. |
| Group 2: Period 7 | Experimental | Drug: RosuvastatinParticipants will receive a single dose of rosuvastatin in the morning on Day 106. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElecoglipronElecoglipron will be administered as oral tablet. | Drug | Group 1: Period 2, Group 1: Period 3, Group 1: Period 4, Group 1: Period 5, Group 1: Period 6, Group 2: Period 1, Group 2: Period 2, Group 2: Period 3, Group 2: Period 4, Group 2: Period 5, Group 2: Period 6 |
| AtorvastatinAtorvastatin will be administered as oral tablet. | Drug | Group 1: Period 1, Group 1: Period 2, Group 1: Period 3, Group 1: Period 4, Group 1: Period 5, Group 1: Period 6 |
| RosuvastatinRosuvastatin will be administered as oral tablet. | Drug | Group 2: Period 1, Group 2: Period 2, Group 2: Period 3, Group 2: Period 4, Group 2: Period 5, Group 2: Period 6, Group 2: Period 7 |
Primary outcome
Area under concentration-time curve from time 0 to infinity (AUCinf) of atorvastatin
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Number of participants with adverse events (AEs) and adverse event of special interest (AESI)
Time frame: Group 1: Day -28 to Day 74; Group 2: Day -28 to Day 79
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elecoglipron, Atorvastatin and Rosuvastatin in people with Healthy Participants, run by AstraZeneca at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under concentration-time curve from time 0 to infinity (AUCinf) of atorvastatin (time frame: Group 1: Day 1 to Day 71). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.