ObesityPhase 3ElecoglipronNCT07775404
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 3 study testing Elecoglipron in people with Obesity and Overweight, run by AstraZeneca at 49 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Elecoglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 351 participants
- Where
- 49 sitesin 5 countries
- Study dates
- 21 Aug 2026to 13 Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
49 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
49 sites in 5 countries
China31 sites, 30 recruiting
- Not yet recruiting
Research Site
Baotou, 014040
- Recruiting
Research Site
Beijing, 100044
- Recruiting
Research Site
Beijing, 100050
- Not yet recruiting
Research Site
Beijing, 102218
- Recruiting
Research Site
Changde, 415000
- Recruiting
Research Site
Changsha, 410015
- Recruiting
Research Site
Changzhou, 213000
- Recruiting
Research Site
Chengdu, 611130
- Recruiting
Research Site
Hefei, 230601
- Recruiting
Research Site
Huangshi, 435000
- Recruiting
Research Site
Jincheng, 048000
- Not yet recruiting
Research Site
Jinzhou Shi, 121001
- Recruiting
Research Site
Langfang, 065000
- Not yet recruiting
Research Site
Luoyang, 471009
- Recruiting
Research Site
Meihekou, 135022
- Not yet recruiting
Research Site
Nanjing, 210011
- Recruiting
Research Site
Nanyang, 473000
- Recruiting
Research Site
Nanyang, 473009
- Recruiting
Research Site
Shanghai, 201199
- Recruiting
Research Site
Shantou, 515065
- Recruiting
Research Site
Shenyang, 110004
- Recruiting
Research Site
Shenyang, 110023
- Recruiting
Research Site
Shijiazhuang, 050001
- Withdrawn
Research Site
Wuhan, 430010
- Recruiting
Research Site
Wuhu, 241004
- Recruiting
Research Site
Xianyang, 712000
- Not yet recruiting
Research Site
Xuzhou, 221000
- Recruiting
Research Site
Yan’an, 716000
- Recruiting
Research Site
Yueyang, 414000
- Recruiting
Research Site
Zhumadian, 463000
- Recruiting
Research Site
Zibo, 255499
Malaysia8 sites, 8 recruiting
- Recruiting
Research Site
Alor Star, 5460
- Not yet recruiting
Research Site
Kuala Lumpur, 59100
- Recruiting
Research Site
Kuching, 93586
- Not yet recruiting
Research Site
Putrajaya, 62250
- Not yet recruiting
Research Site
Sarawak Miri, 98000
- Not yet recruiting
Research Site
Seremban, 70300
- Recruiting
Research Site
Seri Manjung, 32040
- Recruiting
Research Site
Sungai Buloh, 47000
Thailand5 sites, 5 recruiting
- Recruiting
Research Site
Bangkok, 10400
- Recruiting
Research Site
Bangkok, 10700
- Recruiting
Research Site
Chiang Mai, 50200
- Recruiting
Research Site
Phutthamonthon, 73170
- Recruiting
Research Site
Songkhla, 90110
Philippines3 sites, 3 recruiting
- Not yet recruiting
Research Site
Davao City, PH-8000
- Not yet recruiting
Research Site
Iloilo City, 5000
- Not yet recruiting
Research Site
Manila, 1000
Hong Kong2 sites, 2 recruiting
- Recruiting
Research Site
Hong Kong, 999077
- Not yet recruiting
Research Site
Shatin, Hong Kong
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Overweight
- Being tested
- Elecoglipron, Placebo
- Keywords
- elecoglipron, AZD5004, ECC5004, GLP-1 receptor agonist, Weight loss, Weight management, Type 2 diabetes mellitus
- Medical subject headings
- Obesity, Overweight, Weight Loss, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElecoglipronDrug
Elecoglipron film coated tablet once daily
PlaceboDrug
Placebo matching elecoglipron film-coated tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Dose 1 | Experimental | Active IMP Receives: Drug: Elecoglipron |
| Arm 2 - Dose 2 | Experimental | Active IMP Receives: Drug: Elecoglipron |
| Arm 3 - Placebo | Placebo comparator | Placebo matching elecoglipron Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline to Week 52 in body weight
Percent change from baseline to Week 52 in body weight.
Measured: 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.
Measured: Week 52
Secondary outcomes (2)
Participants achieving at least 10% body weight loss at Week 52
Achieved at least 10% body weight loss from baseline at Week 52.
Measured: Week 52
Change in waist circumference from baseline to Week 52
Absolute change from baseline to Week 52 in waist circumference(cm).
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start21 Aug 2026
- Primary completion6 Apr 2028 (estimated)
- Study completion13 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 351 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775404
- Sponsor's protocol ID
- D7260C00022
- Acronym
- Elecoglipron
- Status last verified
- Jul 2026
- First submitted
- 17 Aug 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07775404
- Acronym / sponsor ID
- Elecoglipron / D7260C00022
- Conditions
- Obesity, Overweight
- Keywords
- elecoglipron, AZD5004, ECC5004, GLP-1 receptor agonist, Weight loss, Weight management, Type 2 diabetes mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 351 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- 6 Apr 2028 (estimated)
- Study completion
- 13 Apr 2028 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Dose 1 | Experimental | Drug: ElecoglipronActive IMP |
| Arm 2 - Dose 2 | Experimental | Drug: ElecoglipronActive IMP |
| Arm 3 - Placebo | Placebo comparator | Drug: PlaceboPlacebo matching elecoglipron |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElecoglipronElecoglipron film coated tablet once daily | Drug | Arm 1 - Dose 1, Arm 2 - Dose 2 |
| PlaceboPlacebo matching elecoglipron film-coated tablet once daily | Drug | Arm 3 - Placebo |
Primary outcome
Percent change from baseline to Week 52 in body weight
Time frame: Week 52
Percent change from baseline to Week 52 in body weight.
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.
2 secondary outcomes
Participants achieving at least 10% body weight loss at Week 52
Time frame: Week 52
Change in waist circumference from baseline to Week 52
Time frame: Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
49 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Elecoglipron in people with Obesity and Overweight, run by AstraZeneca at 49 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in China, Malaysia, Thailand, Philippines, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline to Week 52 in body weight (time frame: Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.