A Phase III Study to Investigate the Efficacy and Safety... | NCT07664553

Studies
A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin

NCT07664553

Sponsor

AstraZeneca

Status

Not yet recruiting

Last Update Posted

Jun 24, 2026Actual

Enrollment

600Estimated

Phase

Phase 3

Conditions

Type 2 Diabetes Mellitus

Interventions

Elecoglipron
Placebo

Countries

United States
Australia
Bulgaria
Canada
China
Czechia
Germany
India
Japan
Malaysia
Poland
South Korea
Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2025-523935-20-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 6, 2026Estimated

Primary Completion Date

May 23, 2028Estimated

Completion Date

May 23, 2028Estimated

First Submitted Date

Jun 18, 2026

First Submission Date that Met QC Criteria

Jun 18, 2026

First Posted Date

Jun 24, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2026

Last Update Posted Date

Jun 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM), treated with a background insulin and other background glucose-lowering medication(s)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elecoglipron dose level 1	Experimental	Participants will receive elecoglipron at dose level 1 administered orally once daily.	Drug: Elecoglipron
Elecoglipron dose level 2	Experimental	Participants will receive elecoglipron at dose level 2 administered orally once daily.	Drug: Elecoglipron
Placebo	Placebo Comparator	Participants will receive placebo administered orally once daily.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Elecoglipron	Drug	Elecoglipron is administered orally once daily.	Elecoglipron dose level 1 Elecoglipron dose level 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Hemoglobin A1c (HbA1c)	Summary statistics	Baseline to Week 40

Secondary Outcomes

Measure	Description	Time Frame
Achieved HbA1c < 7% (53 mmol/mol) at Week 40		Week 40
Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 40		Week 40
Percent change from baseline to Week 40 in body weight

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with T2DM for at least 90 days prior to screening
Stable treatment with background insulin and other background glucose-lowering medication(s)
HbA1c value of ≥ 7% to ≤ 10.5%
Body mass index (BMI) of ≥ 23 kg/m2 at screening
Stable body weight (self-reported or documented) for 90 days prior to screening

Exclusion Criteria:

T1DM, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
History of acute or chronic pancreatitis.
Severe congestive heart failure (NYHA IV)
History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AstraZeneca Clinical Study Information Center	Contact	1-877-240-9479		information.center@astrazeneca.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Little Rock	Arkansas	72205	United States
Research Site

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Not provided

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.

URL

https://vivli.org/

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases