NCT07723833

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for phase_1

Timeline
4mo left

Started Jul 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 Progress5%
Jul 2026Nov 2026

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

July 27, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2026

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 20, 2026

Last Update Submit

July 20, 2026

Conditions

Healthy Participants

Keywords

Glucagon-like peptide receptor agonist (GLP-1RA)Type 2 Diabetes Mellitus (T2DM)Glucose Metabolism DisordersMetabolic DiseasesObesity managementPharmacokineticsRelative bioavailabilityObesity and Related Co-morbidities

Outcome Measures

Primary Outcomes (11)

  • Maximum observed drug concentration (Cmax)

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

    At pre-defined intervals from Day 1 to Day 15

  • Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

    At pre-defined intervals from Day 1 to Day 15

  • Area under concentration-time curve from time 0 to infinity (AUCinf)

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

    At pre-defined intervals from Day 1 to Day 15

  • Time to reach maximum observed concentration (tmax)

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

    At pre-defined intervals from Day 1 to Day 15

  • Terminal elimination rate constant (λz)

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

    At pre-defined intervals from Day 1 to Day 15

  • Terminal elimination half-life (t1/2λz)

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

    At pre-defined intervals from Day 1 to Day 15

  • Apparent total body clearance (CL/F)

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

    At pre-defined intervals from Day 1 to Day 15

  • Apparent volume of distribution based on the terminal phase (Vz/F)

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

    At pre-defined intervals from Day 1 to Day 15

  • Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf)

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

    At pre-defined intervals from Day 1 to Day 15

  • Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast)

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

    At pre-defined intervals from Day 1 to Day 15

  • Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax)

    To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

    At pre-defined intervals from Day 1 to Day 15

Secondary Outcomes (1)

  • Number of participants with adverse events (AEs)

    From screening (Day -28) up to follow-up visit (Day 18-Day 22)

Study Arms (8)

Cohort 1-Treatment Sequence A

EXPERIMENTAL

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.

Drug: Elecoglipron Reference Formulation Dose ADrug: Elecoglipron Test formulation 1 Dose A

Cohort 1 - Treatment Sequence B

EXPERIMENTAL

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.

Drug: Elecoglipron Reference Formulation Dose ADrug: Elecoglipron Test formulation 1 Dose A

Cohort 2 - Treatment Sequence C

EXPERIMENTAL

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.

Drug: Elecoglipron Reference Formulation Dose BDrug: Elecoglipron Test formulation 1 Dose B

Cohort 2 - Treatment Sequence D

EXPERIMENTAL

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.

Drug: Elecoglipron Reference Formulation Dose BDrug: Elecoglipron Test formulation 1 Dose B

Cohort 3 - Treatment Sequence E

EXPERIMENTAL

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.

Drug: Elecoglipron Reference Formulation Dose ADrug: Elecoglipron Test formulation 2 Dose A

Cohort 3 - Treatment Sequence F

EXPERIMENTAL

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.

Drug: Elecoglipron Reference Formulation Dose ADrug: Elecoglipron Test formulation 2 Dose A

Cohort 4 - Treatment Sequence G

EXPERIMENTAL

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.

Drug: Elecoglipron Reference Formulation Dose BDrug: Elecoglipron Test formulation 2 Dose B

Cohort 4 - Treatment Sequence H

EXPERIMENTAL

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.

Drug: Elecoglipron Reference Formulation Dose BDrug: Elecoglipron Test formulation 2 Dose B

Interventions

Elecoglipron Reference Formulation Dose ADRUG

Elecoglipron tablets will be administered orally.

Cohort 1 - Treatment Sequence BCohort 1-Treatment Sequence ACohort 3 - Treatment Sequence ECohort 3 - Treatment Sequence F
Elecoglipron Test formulation 2 Dose BDRUG

Elecoglipron tablets will be administered orally.

Cohort 4 - Treatment Sequence GCohort 4 - Treatment Sequence H
Elecoglipron Test formulation 1 Dose ADRUG

Elecoglipron tablets will be administered orally.

Cohort 1 - Treatment Sequence BCohort 1-Treatment Sequence A
Elecoglipron Reference Formulation Dose BDRUG

Elecoglipron tablets will be administered orally.

Cohort 2 - Treatment Sequence CCohort 2 - Treatment Sequence DCohort 4 - Treatment Sequence GCohort 4 - Treatment Sequence H
Elecoglipron Test formulation 1 Dose BDRUG

Elecoglipron tablets will be administered orally.

Cohort 2 - Treatment Sequence CCohort 2 - Treatment Sequence D
Elecoglipron Test formulation 2 Dose ADRUG

Elecoglipron tablets will be administered orally.

Cohort 3 - Treatment Sequence ECohort 3 - Treatment Sequence F

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

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 2Glucose Metabolism DisordersMetabolic DiseasesObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 23, 2026

Study Start

July 27, 2026

Primary Completion (Estimated)

November 18, 2026

Study Completion (Estimated)

November 18, 2026

Last Updated

July 23, 2026

Record last verified: 2026-07

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://astrazenecagrouptrials.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)