A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants

A Phase I, Randomized, Single-dose, Crossover, 2-Period, Open-Label Study to Assess the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Elecoglipron Reference Formulation Dose A; Drug: Elecoglipron Test formulation 1 Dose A; Drug: Elecoglipron Reference Formulation Dose B; Drug: Elecoglipron Test formulation 1 Dose B; Drug: Elecoglipron Test formulation 2 Dose A; Drug: Elecoglipron Test formulation 2 Dose B

Detailed Description

This is a phase I, open-label, randomized, 2-period crossover study with 4-cohorts. All 4 cohorts are independent and non-sequential parts in this study. Each cohort will evaluate 2 formulations (test formulation and reference formulation) of elecoglipron across 2 study treatment periods. Participants within each cohort will be randomized to one of 2 treatment sequences (Test-Reference or Reference-Test).

In total 3 formulations will be evaluated at 2 dose levels each:

• Reference formulation
• Test formulation 1
• Test formulation 2

The study will comprise:

• A Screening Period.
• 2 treatment periods in each cohort - Period 1, and Period 2 during which participants will be admitted to the Clinical Unit and receive a single oral dose of elecoglipron in each period.
• A final Follow-up Visit.

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Research Site
  • Maryland
    • Brooklyn, Maryland, United States, 21225
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Elecoglipron Reference Formulation Dose A; Elecoglipron tablets will be administered orally.; Drug: Elecoglipron Test formulation 1 Dose A; Elecoglipron tablets will be administered orally.
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.	Drug: Elecoglipron Reference Formulation Dose A; Elecoglipron tablets will be administered orally.; Drug: Elecoglipron Test formulation 1 Dose A; Elecoglipron tablets will be administered orally.
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.	Drug: Elecoglipron Reference Formulation Dose B; Elecoglipron tablets will be administered orally.; Drug: Elecoglipron Test formulation 1 Dose B; Elecoglipron tablets will be administered orally.
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.	Drug: Elecoglipron Reference Formulation Dose B; Elecoglipron tablets will be administered orally.; Drug: Elecoglipron Test formulation 1 Dose B; Elecoglipron tablets will be administered orally.
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.	Drug: Elecoglipron Reference Formulation Dose A; Elecoglipron tablets will be administered orally.; Drug: Elecoglipron Test formulation 2 Dose A; Elecoglipron tablets will be administered orally.
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.	Drug: Elecoglipron Reference Formulation Dose A; Elecoglipron tablets will be administered orally.; Drug: Elecoglipron Test formulation 2 Dose A; Elecoglipron tablets will be administered orally.
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.	Drug: Elecoglipron Reference Formulation Dose B; Elecoglipron tablets will be administered orally.; Drug: Elecoglipron Test formulation 2 Dose B; Elecoglipron tablets will be administered orally.
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.	Drug: Elecoglipron Reference Formulation Dose B; Elecoglipron tablets will be administered orally.; Drug: Elecoglipron Test formulation 2 Dose B; Elecoglipron tablets will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs)	To assess the safety and tolerability of different formulations of elecoglipron following single oral administration in healthy participants.	From screening (Day -28) up to follow-up visit (Day 18-Day 22)

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): July 27, 2026
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): November 18, 2026

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Glucose Metabolism Disorders; Metabolic Diseases; Type 2 Diabetes Mellitus (T2DM); Relative bioavailability; Obesity management; Glucagon-like peptide receptor agonist (GLP-1RA); Obesity and Related Co-morbidities
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Overnutrition; Body Weight; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: D7260C00023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No