Embold

RecruitingPhase 3

A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (Embold)

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

325

Recruiting sites

220

Estimated enrollment

4,500

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30•HbA1c ≥6.5%

Primary endpoint

•Percent body weight loss

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07667803

Org study IDD7260C00015

Secondary ID2025

Secondary ID2025-524688-19EU CT number

Timeline

Milestones

Study first posted2026-06-25actual

Study start2026-06-29actual

Last update posted2026-10-13actual

Primary completion2028-07-31estimated

Study completion2029-07-30estimated

Assets

Investigational agents

AZD5004 / ECC5004

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Legal age of consent and at least 18 years old

•Study 1 -

-BMI ≥ 30 kg/m2 or

-25 kg/m2 ≤ BMI < 30 kg/m2 with at least one of the following weight-related comorbidities:

-Hypertension

-Prediabetes

-Dyslipidemia

-Cardiovascular disease

-Obstructive sleep apnea.

•Study 2 - BMI ≥ 25 kg/m2 and T2DM defined as below:

-Established diagnosis of T2DM

-Without established diagnosis of T2DM and HbA1c ≥ 6.5% (48 mmol/mol) at the screening visit

•Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)

•History of at least one self-reported unsuccessful dietary effort to lose body weight.

Exclusion criteria

•Study 1 - Established diagnosis of T1DM or T2DM.

•Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes:

-T1DM

-HbA1c ≥ 10% (86 mmol/mol) at the screening visit

-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 the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms

•History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis

•History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

5 endpoints

Primary/protocol endpoint

Percent body weight loss

Time frame:72 weeks

descriptive

Secondary/protocol endpoint

Absolute body weight loss

Time frame:72 weeks

descriptive

Secondary/protocol endpoint

Total body weight loss of at least 5%, 10%, and 15%

Time frame:72 weeks

descriptive

Secondary/protocol endpoint

Percent body weight loss in participants with body mass index (BMI) ≥ 27 kg/m2 at baseline

Time frame:72 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Waist circumference reduction

Time frame:72 weeks

descriptive

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Glycemic control

Time frame:72 weeks

descriptive

Secondary/protocol endpoint

Achieving normoglycemia in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline

Time frame:72 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Study 2 only: Achieving glycemic control in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline

Time frame:72 weeks

threshold achievement, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Systolic blood pressure reduction

Time frame:72 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.