Elecoglipron

RecruitingPhase 3

A Study to Investigate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (EMBOLD-Asia)

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

351

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•HbA1c ≤10%

Primary endpoints

•Body weight•Participants achieving at least 5% 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 IDNCT07775404

Org study IDD7260C00022

Timeline

Milestones

Study first posted2026-08-20actual

Study start2026-08-21actual

Last update posted2026-10-01actual

Primary completion2028-04-06estimated

Study completion2028-04-13estimated

Assets

Investigational agents

AZD5004 / ECC5004

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Adult participant aged 18 years or older at the time of informed consent.

•Body mass index (BMI) at screening of:

•28 kg/m^2 or higher, or

•24 kg/m^2 to less than 28 kg/m^2 with at least 1 weight-related comorbidity.

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

•History of at least 1 self-reported unsuccessful dietary effort to lose body weight.

•Participants with type 2 diabetes mellitus, if enrolled, and have HbA1c from 6.5% to less than 10.0% at screening.

Exclusion criteria

•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 (4)

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.

Weight & body composition

4 endpoints

Primary/protocol endpoint

Percent change from baseline to Week 52 in body weight

Time frame:Week 52

percent change from baseline, improvement

Primary/protocol endpoint

Participants achieving at least 5% body weight loss at Week 52

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Participants achieving at least 10% body weight loss at Week 52

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Change in waist circumference from baseline to Week 52

Time frame:Week 52

change from baseline, improvement

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.