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
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)
1 other identifier
interventional
351
5 countries
49
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started Aug 2026
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2026
CompletedFirst Posted
Study publicly available on registry
August 20, 2026
CompletedStudy Start
First participant enrolled
August 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 20, 2028
August 27, 2026
July 1, 2026
10 months
August 17, 2026
August 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent change from baseline to Week 52 in body weight
Percent change from baseline to Week 52 in body weight.
Week 52
Participants achieving at least 5% body weight loss at Week 52
Achieved at least 5% body weight loss from baseline at Week 52.
Week 52
Secondary Outcomes (2)
Participants achieving at least 10% body weight loss at Week 52
Week 52
Change in waist circumference from baseline to Week 52
Week 52
Study Arms (3)
Arm 1 - Dose 1
EXPERIMENTALActive IMP
Arm 2 - Dose 2
EXPERIMENTALActive IMP
Arm 3 - Placebo
PLACEBO COMPARATORPlacebo matching elecoglipron
Interventions
Eligibility Criteria
You may qualify if:
- Adult participant aged 18 years or older at the time of informed consent.
- Body mass index (BMI) at screening of:
- kg/m\^2 or higher, or
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (49)
Research Site
Baotou, 014040, China
Research Site
Beijing, 100044, China
Research Site
Beijing, 100050, China
Research Site
Beijing, 102218, China
Research Site
Changde, 415000, China
Research Site
Changsha, 410015, China
Research Site
Changzhou, 213000, China
Research Site
Chengdu, 611130, China
Research Site
Hefei, 230601, China
Research Site
Huangshi, 435000, China
Research Site
Jincheng, 048000, China
Research Site
Jinzhou Shi, 121001, China
Research Site
Langfang, 065000, China
Research Site
Luoyang, 471009, China
Research Site
Meihekou, 135022, China
Research Site
Nanjing, 210011, China
Research Site
Nanyang, 473000, China
Research Site
Nanyang, 473009, China
Research Site
Shanghai, 201199, China
Research Site
Shantou, 515065, China
Research Site
Shenyang, 110004, China
Research Site
Shenyang, 110023, China
Research Site
Shijiazhuang, 050001, China
Research Site
Wuhan, 430010, China
Research Site
Wuhu, 241004, China
Research Site
Xianyang, 712000, China
Research Site
Xuzhou, 221000, China
Research Site
Yan’an, 716000, China
Research Site
Yueyang, 414000, China
Research Site
Zhumadian, 463000, China
Research Site
Zibo, 255499, China
Research Site
Hong Kong, 999077, Hong Kong
Research Site
Randwick, 2031, Hong Kong
Research Site
Alor Star, 5460, Malaysia
Research Site
Kuala Lumpur, 59100, Malaysia
Research Site
Kuching, 93586, Malaysia
Research Site
Putrajaya, 62250, Malaysia
Research Site
Sarawak Miri, 98000, Malaysia
Research Site
Seremban, 70300, Malaysia
Research Site
Seri Manjung, 32040, Malaysia
Research Site
Sungai Buloh, 47000, Malaysia
Research Site
Davao City, PH-8000, Philippines
Research Site
Iloilo City, 5000, Philippines
Research Site
Manila, 1000, Philippines
Research Site
Bangkok, 10400, Thailand
Research Site
Bangkok, 10700, Thailand
Research Site
Chiang Mai, 50200, Thailand
Research Site
Phutthamonthon, 73170, Thailand
Research Site
Songkhla, 90110, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2026
First Posted
August 20, 2026
Study Start
August 21, 2026
Primary Completion (Estimated)
June 4, 2027
Study Completion (Estimated)
April 20, 2028
Last Updated
August 27, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
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.