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RecruitingNCT07775404ElecoglipronUpdated Aug 27, 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 2026-08-27.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

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

Who can participate

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

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

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.
04

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

  • DrugElecoglipron

    Elecoglipron film coated tablet once daily

  • DrugPlacebo

    Placebo matching elecoglipron film-coated tablet once daily

05

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

06

Study locations

3 of 49 sites recruiting
  • Research Site
    Baotou, 014040, China
    Not yet recruiting
  • Research Site
    Beijing, 100044, China
    Not yet recruiting
  • Research Site
    Beijing, 100050, China
    Not yet recruiting
  • Research Site
    Beijing, 102218, China
    Not yet recruiting
  • Research Site
    Changde, 415000, China
    Not yet recruiting
  • Research Site
    Changsha, 410015, China
    Not yet recruiting
  • Research Site
    Changzhou, 213000, China
    Not yet recruiting
  • Research Site
    Chengdu, 611130, China
    Recruiting
  • Research Site
    Hefei, 230601, China
    Not yet recruiting
  • Research Site
    Huangshi, 435000, China
    Not yet recruiting
  • Research Site
    Jincheng, 048000, China
    Recruiting
  • Research Site
    Jinzhou Shi, 121001, China
    Not yet recruiting
  • Research Site
    Langfang, 065000, China
    Not yet recruiting
  • Research Site
    Luoyang, 471009, China
    Not yet recruiting
  • Research Site
    Meihekou, 135022, China
    Not yet recruiting
  • Research Site
    Nanjing, 210011, China
    Not yet recruiting
  • Research Site
    Nanyang, 473000, China
    Not yet recruiting
  • Research Site
    Nanyang, 473009, China
    Not yet recruiting
  • Research Site
    Shanghai, 201199, China
    Not yet recruiting
  • Research Site
    Shantou, 515065, China
    Not yet recruiting
  • Research Site
    Shenyang, 110004, China
    Not yet recruiting
  • Research Site
    Shenyang, 110023, China
    Not yet recruiting
  • Research Site
    Shijiazhuang, 050001, China
    Not yet recruiting
  • Research Site
    Wuhan, 430010, China
    Withdrawn
  • Research Site
    Wuhu, 241004, China
    Not yet recruiting
  • Research Site
    Xianyang, 712000, China
    Not yet recruiting
  • Research Site
    Xuzhou, 221000, China
    Not yet recruiting
  • Research Site
    Yan’an, 716000, China
    Not yet recruiting
  • Research Site
    Yueyang, 414000, China
    Not yet recruiting
  • Research Site
    Zhumadian, 463000, China
    Not yet recruiting
  • Research Site
    Zibo, 255499, China
    Not yet recruiting
  • Research Site
    Hong Kong, 999077, Hong Kong
    Recruiting
  • Research Site
    Randwick, 2031, Hong Kong
    Not yet recruiting
  • Research Site
    Alor Star, 5460, Malaysia
    Not yet recruiting
  • Research Site
    Kuala Lumpur, 59100, Malaysia
    Not yet recruiting
  • Research Site
    Kuching, 93586, Malaysia
    Not yet recruiting
  • Research Site
    Putrajaya, 62250, Malaysia
    Not yet recruiting
  • Research Site
    Sarawak Miri, 98000, Malaysia
    Not yet recruiting
  • Research Site
    Seremban, 70300, Malaysia
    Not yet recruiting
  • Research Site
    Seri Manjung, 32040, Malaysia
    Not yet recruiting
  • Research Site
    Sungai Buloh, 47000, Malaysia
    Not yet 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
    Not yet recruiting
  • Research Site
    Bangkok, 10700, Thailand
    Not yet recruiting
  • Research Site
    Chiang Mai, 50200, Thailand
    Not yet recruiting
  • Research Site
    Phutthamonthon, 73170, Thailand
    Not yet recruiting
  • Research Site
    Songkhla, 90110, Thailand
    Not yet recruiting
07

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, Sap

No publications or documents are linked to this record.

08

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
Jun 4, 2027 (estimated)
Completion
Apr 20, 2028 (estimated)
Last update
Aug 27, 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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