Recruiting
Phase 1

Elecoglipron

Sponsor:

AstraZeneca

Code:

NCT07723833

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Elecoglipron Reference Formulation Dose A

Elecoglipron Test formulation 1 Dose A

Elecoglipron Reference Formulation Dose B

Elecoglipron Test formulation 1 Dose B

Elecoglipron Test formulation 2 Dose A

Study Details

Brief summary:

The purpose of this study is to measure the pharmacokinetics (PK-how the body processes the study drug) of elecoglipron in healthy participants when taken by mouth as different formulations.

Conditions

Healthy Participants

Study ID

NCT07723833

Start date

Jul 27, 2026

Status verified date

Sep, 2026

Completion date

Nov 18, 2026

Anticipated

Primary completion date

Nov 18, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy participants with suitable veins for cannulation or repeated venipuncture.
  • 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.
  • Females of non-childbearing potential must be confirmed at screening visit as postmenopausal or have documentation of irreversible surgical sterilization.
  • Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods.
  • Have a body mass index between 18.5 and 30 kg/m2 inclusive and weigh at least 50 kg.

Exclusion Criteria:

  • History of any clinically important disease or disorder.
  • 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.
  • Participants who have previously received elecoglipron within the last 3 months.

Study Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1-Treatment Sequence A

Participant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose A) in Period 2.

experimental: Cohort 1 - Treatment Sequence B

Participant will receive a single dose of elecoglipron test formulation 1 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2.

experimental: Cohort 2 - Treatment Sequence C

Participant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose B) in Period 2.

experimental: Cohort 2 - Treatment Sequence D

Participant will receive a single dose of elecoglipron test formulation 1 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2.

experimental: Cohort 3 - Treatment Sequence E

Participant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose A) in Period 2.

experimental: Cohort 3 - Treatment Sequence F

Participant will receive a single dose of elecoglipron test formulation 2 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2.

experimental: Cohort 4 - Treatment Sequence G

Participant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose B) in Period 2.

experimental: Cohort 4 - Treatment Sequence H

Participant will receive a single dose of elecoglipron test formulation 2 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2.

Interventions

Elecoglipron Reference Formulation Dose A

Elecoglipron tablets will be administered orally.

Elecoglipron Test formulation 1 Dose A

Elecoglipron tablets will be administered orally.

Elecoglipron Reference Formulation Dose B

Elecoglipron tablets will be administered orally.

Elecoglipron Test formulation 1 Dose B

Elecoglipron tablets will be administered orally.

Elecoglipron Test formulation 2 Dose A

Elecoglipron tablets will be administered orally.

Elecoglipron Test formulation 2 Dose B

Elecoglipron tablets will be administered orally.

Primary outcome measure

  • Maximum observed drug concentration (Cmax) [ Time Frame: At pre-defined intervals from Day 1 to Day 15 ]
  • Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) [ Time Frame: At pre-defined intervals from Day 1 to Day 15 ]
  • Area under concentration-time curve from time 0 to infinity (AUCinf) [ Time Frame: At pre-defined intervals from Day 1 to Day 15 ]
  • Time to reach maximum observed concentration (tmax) [ Time Frame: At pre-defined intervals from Day 1 to Day 15 ]
  • Terminal elimination rate constant (λz) [ Time Frame: At pre-defined intervals from Day 1 to Day 15 ]
  • Terminal elimination half-life (t1/2λz) [ Time Frame: At pre-defined intervals from Day 1 to Day 15 ]
  • Apparent total body clearance (CL/F) [ Time Frame: At pre-defined intervals from Day 1 to Day 15 ]
  • Apparent volume of distribution based on the terminal phase (Vz/F) [ Time Frame: At pre-defined intervals from Day 1 to Day 15 ]
  • Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf) [ Time Frame: At pre-defined intervals from Day 1 to Day 15 ]
  • Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast) [ Time Frame: At pre-defined intervals from Day 1 to Day 15 ]
  • Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax) [ Time Frame: At pre-defined intervals from Day 1 to Day 15 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Glendale, California, United States, 91206

Research Site

Recruiting

Brooklyn, Maryland, United States, 21225

More Information

Sponsor

AstraZeneca

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Keywords

  • Glucagon-like peptide receptor agonist (GLP-1RA)
  • Type 2 Diabetes Mellitus (T2DM)
  • Glucose Metabolism Disorders
  • Metabolic Diseases
  • Obesity management
  • Pharmacokinetics
  • Relative bioavailability
  • Obesity and Related Co-morbidities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.