A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM (Embold)

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (Embold)

This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).

Study Overview

• Status: Not yet recruiting
• Conditions: Weight Management
• Intervention / Treatment: Drug: Elecoglipron; Drug: Placebo

Detailed Description

This is a Phase III, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 2 doses of elecoglipron compared with placebo, given once daily as oral tablets. This protocol covers two independent pivotal studies in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 25 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Prediabetes, Dyslipidemia, CV disease and/or Obstructive sleep apnea) without T2DM (Study 1) and as well as those who are living with obesity or overweight with T2DM (Study 2). Approximately 3000 participants will be randomized in the study 1 and 1500 participants in the study 2. The primary endpoint is percent change in body weight from baseline at 72 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 4500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425AGC
    • Research Site
  • CABA, Argentina, C1061
    • Research Site
  • CABA, Argentina, C1120AAC
    • Research Site
  • San Nicolás, Argentina, B2900DMH
    • Research Site
• Australia
  • Botany, Australia, 2019
    • Research Site
  • Malvern, Australia, 3144
    • Research Site
  • St Albans, Australia, 3021
    • Research Site
  • St Leonards, Australia, 2065
    • Research Site
• Brazil
  • Belém, Brazil, 66073-005
    • Research Site
  • Campinas, Brazil, 13060-080
    • Research Site
  • Curitiba, Brazil, 80045-170
    • Research Site
  • Fortaleza, Brazil, 60430-350
    • Research Site
  • São Paulo, Brazil, 01228-000
    • Research Site
  • São Paulo, Brazil, 04012-180
    • Research Site
  • São Paulo, Brazil, 01236-030
    • Research Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2V 4J2
      • Research Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • Research Site
  • Nova Scotia
    • Truro, Nova Scotia, Canada, B2N 1L2
      • Research Site
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Research Site
    • Niagara Falls, Ontario, Canada, L2H 1H5
      • Research Site
    • North York, Ontario, Canada, M6B 3H7
      • Research Site
    • Stouffville, Ontario, Canada, L4A1H2
      • Research Site
    • Toronto, Ontario, Canada, M9V 4B4
      • Research Site
    • Toronto, Ontario, Canada, M6G 1M2
      • Research Site
  • Quebec
    • Terrebonne, Quebec, Canada, J6X 4P7
      • Research Site
• Chile
  • Araucania, Chile, 4781151
    • Research Site
  • Las Condes, Chile, 7560908
    • Research Site
  • Osorno, Chile, 5311092
    • Research Site
  • Providencia, Chile, 7500504
    • Research Site
  • Santiago, Chile, 8330034
    • Research Site
  • Santiago, Chile, 8241479
    • Research Site
  • Santiago, Chile, 7691236
    • Research Site
  • Santiago, Chile, 8331143
    • Research Site
  • Temuco, Chile, 4810345
    • Research Site
• Poland
  • Bialystok, Poland, 15-375
    • Research Site
  • Bialystok, Poland, 15-435
    • Research Site
  • Bydgoszcz, Poland, 85-796
    • Research Site
  • Kielce, Poland, 25-355
    • Research Site
  • Krakow, Poland, 31-261
    • Research Site
  • Krakow, Poland, 30-727
    • Research Site
  • Krakow, Poland, 31-271
    • Research Site
  • Lodz, Poland, 90-338
    • Research Site
  • Lublin, Poland, 20-718
    • Research Site
  • Lublin, Poland, 20-064
    • Research Site
  • Poznan, Poland, 60-589
    • Research Site
  • Poznan, Poland, 60-354
    • Research Site
  • Radom, Poland, 26-600
    • Research Site
  • Warsaw, Poland, 02-507
    • Research Site
  • Warsaw, Poland, 02-758
    • Research Site
  • Warsaw, Poland, 00-124
    • Research Site
• South Africa
  • Bellville, South Africa, 7530
    • Research Site
  • Bloemfontein, South Africa, 9301
    • Research Site
  • Cape Town, South Africa, 7764
    • Research Site
  • Cape Town, South Africa, 7500
    • Research Site
  • Chatsworth, South Africa, 4092
    • Research Site
  • Claremont, South Africa, 7708
    • Research Site
  • Durban, South Africa, 4091
    • Research Site
  • Extension 8, Lenasia, South Africa, 1827
    • Research Site
  • Johannesburg, South Africa, 2113
    • Research Site
  • Midrand, South Africa, 1685
    • Research Site
  • Wentworth, South Africa, 4032
    • Research Site
  • eMkhomazi, South Africa, 4170
    • Research Site
• South Korea
  • Busan, South Korea, 49241
    • Research Site
  • Busan, South Korea, 49201
    • Research Site
  • Daegu, South Korea, 42415
    • Research Site
  • Goyang-si, South Korea, 13620
    • Research Site
  • Gyeonggi-do, South Korea, 13620
    • Research Site
  • Incheon, South Korea, 21565
    • Research Site
  • Jongno-gu, South Korea, 110-746
    • Research Site
  • Seoul, South Korea, 120-752
    • Research Site
  • Seoul, South Korea, 02447
    • Research Site
  • Suwon, South Korea, 443-721
    • Research Site
• Taiwan
  • Changhua, Taiwan, 500
    • Research Site
  • Kaohsiung City, Taiwan, 807
    • Research Site
  • Taichung, Taiwan, 40705
    • Research Site
  • Taichung, Taiwan, 40447
    • Research Site
  • Taichung, Taiwan, 402
    • Research Site
  • Taichung, Taiwan, 433004
    • Research Site
  • Tainan, Taiwan, 704
    • Research Site
  • Tainan County, Taiwan, 71044
    • Research Site
  • Taipei, Taiwan, 10002
    • Research Site
  • Taipei, Taiwan, 110
    • Research Site
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01060
    • Research Site
  • Adana, Turkey (Türkiye), 01120
    • Research Site
  • Adapazarı, Turkey (Türkiye), 54290
    • Research Site
  • Ankara, Turkey (Türkiye), 06530
    • Research Site
  • Ankara, Turkey (Türkiye), 6230
    • Research Site
  • Ankara, Turkey (Türkiye), 5000
    • Research Site
  • Antalya, Turkey (Türkiye), 07059
    • Research Site
  • Istanbul, Turkey (Türkiye), 34722
    • Research Site
  • Istanbul, Turkey (Türkiye), 34098
    • Research Site
  • Istanbul, Turkey (Türkiye), 34384
    • Research Site
• United Kingdom
  • Blackpool, United Kingdom, FY3 7EN
    • Research Site
  • Chesterfield, United Kingdom, S40 4AA
    • Research Site
  • Corby, United Kingdom, NN17 2UR
    • Research Site
  • Glasgow, United Kingdom, G51 4TF
    • Research Site
  • Hounslow, United Kingdom, TW3 3LN
    • Research Site
  • Leicester, United Kingdom, Le5 4PW
    • Research Site
  • Metropolitan Borough of Wirral, United Kingdom, CH48 5AA
    • Research Site
  • Poole, United Kingdom, BH16 5PW
    • Research Site
  • Rotherham, United Kingdom, S65 1DA
    • Research Site
  • Soham, United Kingdom, CB7 5JD
    • Research Site
  • Stowmarket, United Kingdom, IP142SY
    • Research Site
  • Wansford, United Kingdom, PE8 6PL
    • Research Site
  • Witney, United Kingdom, OX28 6JS
    • Research Site
  • Yate, United Kingdom, BS37 4AX
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Research Site
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Research Site
  • California
    • Lincoln, California, United States, 95648
      • Research Site
  • Florida
    • Clearwater, Florida, United States, 33765
      • Research Site
  • Georgia
    • Woodstock, Georgia, United States, 30189
      • Research Site
  • Indiana
    • Indianapolis, Indiana, United States, 46254
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Research Site
    • Potomac, Maryland, United States, 20854
      • Research Site
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Research Site
  • New York
    • Albany, New York, United States, 12205
      • Research Site
    • Laurelton, New York, United States, 11413
      • Research Site
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Research Site
    • Raleigh, North Carolina, United States, 27609
      • Research Site
    • Rocky Mount, North Carolina, United States, 27804
      • Research Site
    • Statesville, North Carolina, United States, 28625
      • Research Site
  • Ohio
    • Dayton, Ohio, United States, 45424
      • Research Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Research Site
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Research Site
    • Newport, Pennsylvania, United States, 17074
      • Research Site
  • South Carolina
    • Gaffney, South Carolina, United States, 29340
      • Research Site
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Research Site
    • Knoxville, Tennessee, United States, 37912
      • Research Site
  • Texas
    • Dallas, Texas, United States, 75254
      • Research Site
  • West Virginia
    • Morgantown, West Virginia, United States, 26501
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Legal age of consent and at least 18 years old

• Study 1 -

  • BMI ≥ 30 kg/m2 or
  • 25 kg/m2 ≤ BMI < 30 kg/m2 with at least one of the following weight-related comorbidities:
  • Hypertension
  • Prediabetes
  • Dyslipidemia
  • Cardiovascular disease
  • Obstructive sleep apnea.

• Study 2 - BMI ≥ 25 kg/m2 and T2DM defined as below:

  • Established diagnosis of T2DM
  • Without established diagnosis of T2DM and HbA1c ≥ 6.5% (48 mmol/mol) at the screening visit
• Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)
• History of at least one self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria

• Study 1 - Established diagnosis of T1DM or T2DM.

• Study 2 - 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 - Dose 1; Active IMP	Drug: Elecoglipron; Elecoglipron film-coated tablet once daily; Other Names: Active IMP
Experimental: Arm 2 - Dose 2; Active IMP	Drug: Elecoglipron; Elecoglipron film-coated tablet once daily; Other Names: Active IMP
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 body weight loss	Percent change from baseline to Week 72 in body weight	72 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute body weight loss	Absolute change from baseline to Week 72 in body weight (kg)	72 weeks
Total body weight loss of at least 5%, 10%, and 15%	Achieved ≥ 5% body weight loss from baseline at Week 72; Achieved ≥ 10% body weight loss from baseline at Week 72; Achieved ≥ 15% body weight loss from baseline at Week 72	72 weeks
Percent body weight loss in participants with body mass index (BMI) ≥ 27 kg/m2 at baseline	Percent change from baseline to Week 72 in body weight	72 weeks
Waist circumference reduction	Absolute change from baseline to Week 72 in waist circumference (cm)	72 weeks
Glycemic control	Change from baseline to Week 72 in hemoglobin A1c (HbA1c) (%)	72 weeks
Achieving normoglycemia in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline	Achieved normoglycemia (HbA1c < 5.7% [39 mmol/mol]) at Week 72	72 weeks
Study 2 only: Achieving glycemic control in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline	Achieved HbA1c < 7.0% (53 mmol/mol) at Week 72; Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 72	72 weeks
Systolic blood pressure reduction	Change from baseline to Week 72 in systolic blood pressure (mmHg)	72 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Prof. Melanie Davies, MBChB, Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester; Principal Investigator: Dr. Ania Jastreboff, MD, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): July 6, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 30, 2029

Study Registration Dates

• First Submitted: June 19, 2026
• First Submitted That Met QC Criteria: June 19, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: D7260C00015; 2025-524688-19 (Registry Identifier: EU CT number)

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: Yes
• Studies a U.S. FDA-regulated device product: No