Healthy ParticipantsPhase 1NCT07723833
A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
A Phase 1 study testing Elecoglipron Reference Formulation Dose A, Elecoglipron Test formulation 1 Dose A and Elecoglipron Reference Formulation Dose B in people with Healthy Participants, run by AstraZeneca at 2 sites in United States.
Trial 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. 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 Reference Formulation Dose A, Elecoglipron Test formulation 1 Dose A and Elecoglipron Reference Formulation Dose B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jul 2026to 18 Nov 2026
- Phase
- Phase 1
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
United States2 sites, 2 recruiting
- Recruiting
Research Site
Brooklyn, Maryland, 21225
- Recruiting
Research Site
Glendale, California, 91206
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- 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
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elecoglipron Reference Formulation Dose ADrug
Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 1 Dose ADrug
Elecoglipron tablets will be administered orally.
Elecoglipron Reference Formulation Dose BDrug
Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 1 Dose BDrug
Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 2 Dose ADrug
Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 2 Dose BDrug
Elecoglipron tablets will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Elecoglipron Reference Formulation Dose A; Drug: 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. Receives: Drug: Elecoglipron Reference Formulation Dose A; Drug: 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. Receives: Drug: Elecoglipron Reference Formulation Dose B; Drug: 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. Receives: Drug: Elecoglipron Reference Formulation Dose B; Drug: 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. Receives: Drug: Elecoglipron Reference Formulation Dose A; Drug: 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. Receives: Drug: Elecoglipron Reference Formulation Dose A; Drug: 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. Receives: Drug: Elecoglipron Reference Formulation Dose B; Drug: 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. Receives: Drug: Elecoglipron Reference Formulation Dose B; Drug: Elecoglipron Test formulation 2 Dose B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed drug concentration (Cmax)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At pre-defined intervals from Day 1 to Day 15
Secondary outcomes (1)
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.
Measured: From screening (Day -28) up to follow-up visit (Day 18-Day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start27 Jul 2026
- Primary completion18 Nov 2026 (estimated)
- Study completion18 Nov 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723833
- Sponsor's protocol ID
- D7260C00023
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2026
- Last updated
- 16 Sep 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://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.