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

August 26, 2026 updated by: AstraZeneca

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)

The purpose of this study is to evaluate the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adult participants living with obesity or overweight with or without T2DM.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of oral elecoglipron in adults with obesity or overweight, with or without type 2 diabetes mellitus. Participants will be randomized to receive elecoglipron or placebo in accordance with the study protocol. Efficacy and safety will be assessed throughout the study.

Study Type

Interventional

Enrollment (Estimated)

351

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Baotou, China, 014040
        • Not yet recruiting
        • Research Site
      • Beijing, China, 102218
        • Not yet recruiting
        • Research Site
      • Beijing, China, 100050
        • Not yet recruiting
        • Research Site
      • Beijing, China, 100044
        • Not yet recruiting
        • Research Site
      • Changde, China, 415000
        • Not yet recruiting
        • Research Site
      • Changsha, China, 410015
        • Not yet recruiting
        • Research Site
      • Changzhou, China, 213000
        • Not yet recruiting
        • Research Site
      • Chengdu, China, 611130
        • Recruiting
        • Research Site
      • Hefei, China, 230601
        • Not yet recruiting
        • Research Site
      • Huangshi, China, 435000
        • Not yet recruiting
        • Research Site
      • Jincheng, China, 048000
        • Recruiting
        • Research Site
      • Jinzhou Shi, China, 121001
        • Not yet recruiting
        • Research Site
      • Langfang, China, 065000
        • Not yet recruiting
        • Research Site
      • Luoyang, China, 471009
        • Not yet recruiting
        • Research Site
      • Meihekou, China, 135022
        • Not yet recruiting
        • Research Site
      • Nanjing, China, 210011
        • Not yet recruiting
        • Research Site
      • Nanyang, China, 473009
        • Not yet recruiting
        • Research Site
      • Nanyang, China, 473000
        • Not yet recruiting
        • Research Site
      • Shanghai, China, 201199
        • Not yet recruiting
        • Research Site
      • Shantou, China, 515065
        • Not yet recruiting
        • Research Site
      • Shenyang, China, 110004
        • Not yet recruiting
        • Research Site
      • Shenyang, China, 110023
        • Not yet recruiting
        • Research Site
      • Shijiazhuang, China, 050001
        • Not yet recruiting
        • Research Site
      • Wuhan, China, 430010
        • Withdrawn
        • Research Site
      • Wuhu, China, 241004
        • Not yet recruiting
        • Research Site
      • Xianyang, China, 712000
        • Not yet recruiting
        • Research Site
      • Xuzhou, China, 221000
        • Not yet recruiting
        • Research Site
      • Yan’an, China, 716000
        • Not yet recruiting
        • Research Site
      • Yueyang, China, 414000
        • Not yet recruiting
        • Research Site
      • Zhumadian, China, 463000
        • Not yet recruiting
        • Research Site
      • Zibo, China, 255499
        • Not yet recruiting
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Recruiting
        • Research Site
      • Randwick, Hong Kong, 2031
        • Not yet recruiting
        • Research Site
  • Malaysia
      • Alor Star, Malaysia, 5460
        • Not yet recruiting
        • Research Site
      • Kuala Lumpur, Malaysia, 59100
        • Not yet recruiting
        • Research Site
      • Kuching, Malaysia, 93586
        • Not yet recruiting
        • Research Site
      • Putrajaya, Malaysia, 62250
        • Not yet recruiting
        • Research Site
      • Sarawak Miri, Malaysia, 98000
        • Not yet recruiting
        • Research Site
      • Seremban, Malaysia, 70300
        • Not yet recruiting
        • Research Site
      • Seri Manjung, Malaysia, 32040
        • Not yet recruiting
        • Research Site
      • Sungai Buloh, Malaysia, 47000
        • Not yet recruiting
        • Research Site
  • Philippines
      • Davao City, Philippines, PH-8000
        • Not yet recruiting
        • Research Site
      • Iloilo City, Philippines, 5000
        • Not yet recruiting
        • Research Site
      • Manila, Philippines, 1000
        • Not yet recruiting
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Not yet recruiting
        • Research Site
      • Bangkok, Thailand, 10400
        • Not yet recruiting
        • Research Site
      • Chiang Mai, Thailand, 50200
        • Not yet recruiting
        • Research Site
      • Phutthamonthon, Thailand, 73170
        • Not yet recruiting
        • Research Site
      • Songkhla, Thailand, 90110
        • Not yet recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 - Dose 1
Active IMP
Drug: Elecoglipron
Elecoglipron film coated tablet once daily
Experimental: Arm 2 - Dose 2
Active IMP
Drug: Elecoglipron
Elecoglipron film coated tablet once daily
Placebo Comparator: Arm 3 - Placebo
Placebo matching elecoglipron
Drug: Placebo
Placebo matching elecoglipron film-coated tablet once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change from baseline to Week 52 in body weight
Time Frame: Week 52
Percent change from baseline to Week 52 in body weight.
Week 52
Participants achieving at least 5% body weight loss at Week 52
Time Frame: Week 52
Achieved at least 5% body weight loss from baseline at Week 52.
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants achieving at least 10% body weight loss at Week 52
Time Frame: Week 52
Achieved at least 10% body weight loss from baseline at Week 52.
Week 52
Change in waist circumference from baseline to Week 52
Time Frame: Week 52
Absolute change from baseline to Week 52 in waist circumference(cm).
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2026

Primary Completion (Estimated)

June 4, 2027

Study Completion (Estimated)

April 20, 2028

Study Registration Dates

First Submitted

August 17, 2026

First Submitted That Met QC Criteria

August 17, 2026

First Posted (Actual)

August 20, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D7260C00022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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