ClinicalTrials.gg
RecruitingNCT07775404ElecoglipronUpdated Nov 9, 2026

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 interventional study of Elecoglipron and Placebo in Obesity and Overweight, sponsored by AstraZeneca. Recruiting at 49 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Nov 9, 2026Site recruiting status changedPrimary completion moved+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
351
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Obesity
  • Overweight

Keywords

  • elecoglipron
  • AZD5004
  • ECC5004
  • GLP-1 receptor agonist
  • Weight loss
  • Weight management
  • Type 2 diabetes mellitus
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 351 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult participant aged 18 years or older at the time of .
  • (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 from 6.5% to less than 10.0% at screening.

Exclusion criteria

Exclusion Criteria:

  • Any of the following medical history, laboratory values, or complications related to diabetes:
  • T1DM
  • ≥ 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
351 participants (estimated)

Study arms

  • Experimental
    Arm 1 - Dose 1

    Active IMP

    Drug: Elecoglipron

  • Experimental
    Arm 2 - Dose 2

    Active IMP

    Drug: Elecoglipron

  • Placebo comparator
    Arm 3 - Placebo

    Placebo matching elecoglipron

    Drug: Placebo

Interventions

  • Elecoglipron film coated tablet once daily

  • DrugPlacebo

    Placebo matching elecoglipron film-coated tablet once daily

06

What researchers measure

Primary outcomes

  1. Percent change from baseline to Week 52 in body weight

    Percent change from baseline to Week 52 in body weight.

    Time frame: Week 52

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

    Achieved at least 5% body weight loss from baseline at Week 52.

    Time frame: Week 52

Secondary outcomes

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

    Achieved at least 10% body weight loss from baseline at Week 52.

    Time frame: Week 52

  2. Change in waist circumference from baseline to Week 52

    Absolute change from baseline to Week 52 in waist circumference(cm).

    Time frame: Week 52

07

Study locations

40 of 49 sites recruiting
  • Research Site
    Baotou, 014040, China
    Not yet recruiting
  • Research Site
    Beijing, 100044, China
    Recruiting
  • Research Site
    Beijing, 100050, China
    Recruiting
  • Research Site
    Beijing, 102218, China
    Not yet recruiting
  • Research Site
    Changde, 415000, China
    Recruiting
  • Research Site
    Changsha, 410015, China
    Recruiting
  • Research Site
    Changzhou, 213000, China
    Recruiting
  • Research Site
    Chengdu, 611130, China
    Recruiting
  • Research Site
    Hefei, 230601, China
    Recruiting
  • Research Site
    Huangshi, 435000, China
    Recruiting
  • Research Site
    Jincheng, 048000, China
    Recruiting
  • Research Site
    Jinzhou Shi, 121001, China
    Not yet recruiting
  • Research Site
    Langfang, 065000, China
    Recruiting
  • Research Site
    Luoyang, 471009, China
    Not yet recruiting
  • Research Site
    Meihekou, 135022, China
    Recruiting
  • Research Site
    Nanjing, 210011, China
    Recruiting
  • Research Site
    Nanyang, 473000, China
    Recruiting
  • Research Site
    Nanyang, 473009, China
    Recruiting
  • Research Site
    Shanghai, 201199, China
    Recruiting
  • Research Site
    Shantou, 515065, China
    Recruiting
  • Research Site
    Shenyang, 110004, China
    Recruiting
  • Research Site
    Shenyang, 110023, China
    Recruiting
  • Research Site
    Shijiazhuang, 050001, China
    Recruiting
  • Research Site
    Wuhan, 430010, China
    Withdrawn

    Not enrolling at this site — choose another above.

  • Research Site
    Wuhu, 241004, China
    Recruiting
  • Research Site
    Xianyang, 712000, China
    Recruiting
  • Research Site
    Xuzhou, 221000, China
    Recruiting
  • Research Site
    Yan’an, 716000, China
    Recruiting
  • Research Site
    Yueyang, 414000, China
    Recruiting
  • Research Site
    Zhumadian, 463000, China
    Recruiting
  • Research Site
    Zibo, 255499, China
    Recruiting
  • Research Site
    Hong Kong, 999077, Hong Kong
    Recruiting
  • Research Site
    Shatin, Hong Kong, Hong Kong
    Recruiting
  • Research Site
    Alor Star, 5460, Malaysia
    Recruiting
  • Research Site
    Kuala Lumpur, 59100, Malaysia
    Recruiting
  • Research Site
    Kuching, 93586, Malaysia
    Recruiting
  • Research Site
    Putrajaya, 62250, Malaysia
    Recruiting
  • Research Site
    Sarawak Miri, 98000, Malaysia
    Recruiting
  • Research Site
    Seremban, 70300, Malaysia
    Not yet recruiting
  • Research Site
    Seri Manjung, 32040, Malaysia
    Recruiting
  • Research Site
    Sungai Buloh, 47000, Malaysia
    Recruiting
  • Research Site
    Davao City, PH-8000, Philippines
    Not yet recruiting
  • Research Site
    Iloilo City, 5000, Philippines
    Not yet recruiting
  • Research Site
    Manila, 1000, Philippines
    Not yet recruiting
  • Research Site
    Bangkok, 10400, Thailand
    Recruiting
  • Research Site
    Bangkok, 10700, Thailand
    Recruiting
  • Research Site
    Chiang Mai, 50200, Thailand
    Recruiting
  • Research Site
    Phutthamonthon, 73170, Thailand
    Recruiting
  • Research Site
    Songkhla, 90110, Thailand
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

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.

Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Apr 2028, 19 months after the start.

Of 198 industry-sponsored phase 3 interventional studies under Obesity, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 27. This study's planned 19 months is close to that.

Counting every sponsor, half of 261 studies reached it within 24 months; a quarter within 18 and three quarters within 34.

Primary completion moved once since we started tracking on Sep 25, 2026: Jun 2027 → Apr 2028, on Oct 1, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 20, 2026
StartActual
Aug 21, 2026
Primary completionEst.
Apr 6, 2028was Jun 2027
CompletionEst.
Apr 13, 2028
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed. 33 sites changed recruiting status (33 now recruiting)
Show 33 sites
  • Research Site · Beijing, ChinaNot yet recruiting→Recruiting
  • Research Site · Changde, ChinaNot yet recruiting→Recruiting
  • Research Site · Changsha, ChinaNot yet recruiting→Recruiting
  • Research Site · Changzhou, ChinaNot yet recruiting→Recruiting
  • Research Site · Hefei, ChinaNot yet recruiting→Recruiting
  • Research Site · Huangshi, ChinaNot yet recruiting→Recruiting
  • Research Site · Langfang, ChinaNot yet recruiting→Recruiting
  • Research Site · Meihekou, ChinaNot yet recruiting→Recruiting
  • Research Site · Nanyang, ChinaNot yet recruiting→Recruiting
  • Research Site · Shanghai, ChinaNot yet recruiting→Recruiting
  • Research Site · Shantou, ChinaNot yet recruiting→Recruiting
  • Research Site · Shenyang, ChinaNot yet recruiting→Recruiting
  • Research Site · Shijiazhuang, ChinaNot yet recruiting→Recruiting
  • Research Site · Wuhu, ChinaNot yet recruiting→Recruiting
  • Research Site · Xianyang, ChinaNot yet recruiting→Recruiting
  • Research Site · Yan’an, ChinaNot yet recruiting→Recruiting
  • Research Site · Yueyang, ChinaNot yet recruiting→Recruiting
  • Research Site · Zhumadian, ChinaNot yet recruiting→Recruiting
  • Research Site · Zibo, ChinaNot yet recruiting→Recruiting
  • Research Site · Alor Star, MalaysiaNot yet recruiting→Recruiting
  • Research Site · Kuching, MalaysiaNot yet recruiting→Recruiting
  • Research Site · Seri Manjung, MalaysiaNot yet recruiting→Recruiting
  • Research Site · Sungai Buloh, MalaysiaNot yet recruiting→Recruiting
  • Research Site · Bangkok, ThailandNot yet recruiting→Recruiting
  • Research Site · Chiang Mai, ThailandNot yet recruiting→Recruiting
  • Research Site · Phutthamonthon, ThailandNot yet recruiting→Recruiting
  • Research Site · Songkhla, ThailandNot yet recruiting→Recruiting
  • Research Site · Nanjing, ChinaNot yet recruiting→Recruiting
  • Research Site · Xuzhou, ChinaNot yet recruiting→Recruiting
  • Research Site · Shatin, Hong Kong, Hong KongNot yet recruiting→Recruiting
  • …and 3 more on the registry record
Show site
  • Research Site · Shatin, Hong Kong, Hong Kong
Show 1 removed
  • Research Site · Randwick, Hong Kong
across 2 updates, Oct 1, 2026 – Nov 9, 2026
Primary completion
Jun 4, 2027→Apr 6, 2028
Oct 1, 2026
Study completion
Apr 20, 2028→Apr 13, 2028
Oct 1, 2026
Show all 2 updates
  1. Nov 9, 2026
    6 sites changed recruiting status (6 now recruiting)
    Show 6 sites
    • Research Site · Nanjing, ChinaNot yet recruiting→Recruiting
    • Research Site · Xuzhou, ChinaNot yet recruiting→Recruiting
    • Research Site · Shatin, Hong Kong, Hong KongNot yet recruiting→Recruiting
    • Research Site · Kuala Lumpur, MalaysiaNot yet recruiting→Recruiting
    • Research Site · Putrajaya, MalaysiaNot yet recruiting→Recruiting
    • Research Site · Sarawak Miri, MalaysiaNot yet recruiting→Recruiting
    + 1 other change: verification date
  2. Oct 1, 2026
    1 site added, 1 site removed. 31 sites changed recruiting status (31 now recruiting)
    Show 31 sites
    • Research Site · Beijing, ChinaNot yet recruiting→Recruiting
    • Research Site · Beijing, ChinaNot yet recruiting→Recruiting
    • Research Site · Changde, ChinaNot yet recruiting→Recruiting
    • Research Site · Changsha, ChinaNot yet recruiting→Recruiting
    • Research Site · Changzhou, ChinaNot yet recruiting→Recruiting
    • Research Site · Hefei, ChinaNot yet recruiting→Recruiting
    • Research Site · Huangshi, ChinaNot yet recruiting→Recruiting
    • Research Site · Langfang, ChinaNot yet recruiting→Recruiting
    • Research Site · Meihekou, ChinaNot yet recruiting→Recruiting
    • Research Site · Nanyang, ChinaNot yet recruiting→Recruiting
    • Research Site · Nanyang, ChinaNot yet recruiting→Recruiting
    • Research Site · Shanghai, ChinaNot yet recruiting→Recruiting
    • Research Site · Shantou, ChinaNot yet recruiting→Recruiting
    • Research Site · Shenyang, ChinaNot yet recruiting→Recruiting
    • Research Site · Shenyang, ChinaNot yet recruiting→Recruiting
    • Research Site · Shijiazhuang, ChinaNot yet recruiting→Recruiting
    • Research Site · Wuhu, ChinaNot yet recruiting→Recruiting
    • Research Site · Xianyang, ChinaNot yet recruiting→Recruiting
    • Research Site · Yan’an, ChinaNot yet recruiting→Recruiting
    • Research Site · Yueyang, ChinaNot yet recruiting→Recruiting
    • Research Site · Zhumadian, ChinaNot yet recruiting→Recruiting
    • Research Site · Zibo, ChinaNot yet recruiting→Recruiting
    • Research Site · Alor Star, MalaysiaNot yet recruiting→Recruiting
    • Research Site · Kuching, MalaysiaNot yet recruiting→Recruiting
    • Research Site · Seri Manjung, MalaysiaNot yet recruiting→Recruiting
    • Research Site · Sungai Buloh, MalaysiaNot yet recruiting→Recruiting
    • Research Site · Bangkok, ThailandNot yet recruiting→Recruiting
    • Research Site · Bangkok, ThailandNot yet recruiting→Recruiting
    • Research Site · Chiang Mai, ThailandNot yet recruiting→Recruiting
    • Research Site · Phutthamonthon, ThailandNot yet recruiting→Recruiting
    • …and 1 more on the registry record
    Show site
    • Research Site · Shatin, Hong Kong, Hong Kong
    Show 1 removed
    • Research Site · Randwick, Hong Kong
    Primary completion Jun 4, 2027→Apr 6, 2028
    Study completion Apr 20, 2028→Apr 13, 2028

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07775404
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 20, 2026
Start date
Aug 21, 2026
Primary completion
Apr 6, 2028 (estimated)
Completion
Apr 13, 2028 (estimated)
Last update
Nov 9, 2026

Study contacts

AstraZeneca Clinical Study Information Center
Contact
information.center@astrazeneca.com
1-877-240-9479

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Elecoglipron

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