A Phase 1 interventional study of Elecoglipron Reference Formulation Dose A and Elecoglipron Test formulation 1 Dose A in Healthy Participants, sponsored by AstraZeneca. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
Among 333 studies in Diabetes Mellitus, Type 2 by AstraZeneca — 13 open to participants now, 15 under way, 9 of them phase 3. Diabetes Mellitus, Type 2 · AstraZeneca.
Among the 333 studies in Diabetes Mellitus, Type 2 by AstraZeneca, this one is the 143rd largest by planned enrollment of the 269 interventional ones that give a count, is one of 14 that started in 2026, is one of 82 in phase 1, reaches primary completion later than 0 of the 14 other live ones, and was the 329th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →13 of the 333 studies in Diabetes Mellitus, Type 2 by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in United States, Argentina, Brazil and 8 more countries
AstraZeneca · Sites in China, Hong Kong, Malaysia and 2 more countries
AstraZeneca · Sites in United States, Argentina, Australia and 13 more countries
AstraZeneca · Sites in United States, Australia, Bulgaria and 10 more countries
AstraZeneca · Sites in United States, Argentina, China and 10 more countries
By country, each count listing its studies:
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
333 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 84 · Phase 2 40 · Phase 3 122 · Phase 4 28
First in 2001; this study’s year is marked. 14 started in 2026.
This study's planned enrollment of 152 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 165 across the 269 interventional studies, 2,075 across the 64 observational. Of the 313 that completed or were terminated, 142 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
5 of the studies in Diabetes Mellitus, Type 2 by AstraZeneca that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07723833AstraZenecaA Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants | 2026-11-18 |
| NCT07024823AstraZenecaA Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of Creatinine in a Non Interventional Cohort | 2026-12-25 |
| NCT07534592AstraZenecaA Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy Participants | 2027-01-25 |
| NCT06151964AstraZenecaA Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight | 2027-01-29 |
| NCT07606066AstraZenecaA Study to Identify and Characterize Patients With Type 2 Diabetes Mellitus for Possible Participation in Ongoing or Future Type 2 Diabetes Mellitus Clinical Studies | 2027-03-31 |
Among the 333 studies in Diabetes Mellitus, Type 2 by AstraZeneca, from their registry updates:
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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.
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:
The study will comprise:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: Elecoglipron Test formulation 1 Dose A
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 · Drug: Elecoglipron Test formulation 1 Dose A
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 · Drug: Elecoglipron Test formulation 1 Dose B
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 · Drug: Elecoglipron Test formulation 1 Dose B
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 · Drug: Elecoglipron Test formulation 2 Dose A
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 · Drug: Elecoglipron Test formulation 2 Dose A
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 · Drug: Elecoglipron Test formulation 2 Dose B
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 · Drug: Elecoglipron Test formulation 2 Dose B
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
Elecoglipron tablets will be administered orally.
Maximum observed drug concentration (Cmax)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
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)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
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)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
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)
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Time frame: At pre-defined intervals from Day 1 to Day 15
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.
Time frame: From screening (Day -28) up to follow-up visit (Day 18-Day 22)
Plan to share: 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.
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.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Nov 2026, 3 months after the start.
Of 452 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's planned 3 months is below that.
Counting every sponsor, half of 514 studies reached it within 6 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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