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)
2 other identifiers
interventional
4,500
19 countries
321
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2026
Typical duration for phase_3
321 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
June 19, 2026
CompletedFirst Posted
Study publicly available on registry
June 25, 2026
CompletedStudy Start
First participant enrolled
June 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2029
July 10, 2026
July 1, 2026
2.1 years
June 19, 2026
July 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent body weight loss
Percent change from baseline to Week 72 in body weight
72 weeks
Secondary Outcomes (8)
Absolute body weight loss
72 weeks
Total body weight loss of at least 5%, 10%, and 15%
72 weeks
Percent body weight loss in participants with body mass index (BMI) ≥ 27 kg/m2 at baseline
72 weeks
Waist circumference reduction
72 weeks
Glycemic control
72 weeks
- +3 more secondary outcomes
Study Arms (3)
Arm 1 - Dose 1
EXPERIMENTALActive IMP
Arm 2 - Dose 2
EXPERIMENTALActive IMP
Arm 3 - Placebo
PLACEBO COMPARATORPlacebo matching elecoglipron
Interventions
Elecoglipron film-coated tablet once daily
Eligibility Criteria
You may qualify if:
- Legal age of consent and at least 18 years old
- Study 1 -
- BMI ≥ 30 kg/m2 or
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (321)
Research Site
Birmingham, Alabama, 35205, United States
Research Site
Dothan, Alabama, 36305, United States
Research Site
Chandler, Arizona, 85225, United States
Research Site
Peoria, Arizona, 85382, United States
Research Site
Little Rock, Arkansas, 72205, United States
Research Site
Lynwood, California, 90262, United States
Research Site
Rolling Hills Estates, California, 90274, United States
Research Site
Sacramento, California, 95821, United States
Research Site
Arvada, Colorado, 80002, United States
Research Site
New Haven, Connecticut, 06511, United States
Research Site
Clearwater, Florida, 33765, United States
Research Site
Plantation, Florida, 33324, United States
Research Site
Woodstock, Georgia, 30189, United States
Research Site
Ammon, Idaho, 83406, United States
Research Site
Melrose Park, Illinois, 60160, United States
Research Site
Indianapolis, Indiana, 46254, United States
Research Site
Wichita, Kansas, 67218, United States
Research Site
Louisville, Kentucky, 40213, United States
Research Site
Alexandria, Louisiana, 71303, United States
Research Site
Baltimore, Maryland, 21229, United States
Research Site
Potomac, Maryland, 20854, United States
Research Site
White Marsh, Maryland, 21162, United States
Research Site
Ypsilanti, Michigan, 48197, United States
Research Site
Ridgeland, Mississippi, 39157, United States
Research Site
Kansas City, Missouri, 64114, United States
Research Site
St Louis, Missouri, 63123, United States
Research Site
Reno, Nevada, 89511, United States
Research Site
Albuquerque, New Mexico, 87106, United States
Research Site
Albany, New York, 12205, United States
Research Site
Laurelton, New York, 11413, United States
Research Site
Long Island City, New York, 11106, United States
Research Site
Greensboro, North Carolina, 27408, United States
Research Site
Raleigh, North Carolina, 27609, United States
Research Site
Rocky Mount, North Carolina, 27804, United States
Research Site
Statesville, North Carolina, 28625, United States
Research Site
Columbus, Ohio, 43228, United States
Research Site
Dayton, Ohio, 45424, United States
Research Site
Edmond, Oklahoma, 73013, United States
Research Site
Tulsa, Oklahoma, 74133, United States
Research Site
Portland, Oregon, 97223, United States
Research Site
DuBois, Pennsylvania, 15801, United States
Research Site
Newport, Pennsylvania, 17074, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
East Providence, Rhode Island, 02914, United States
Research Site
Charleston, South Carolina, 29407, United States
Research Site
Gaffney, South Carolina, 29340, United States
Research Site
Rapid City, South Dakota, 57701, United States
Research Site
Franklin, Tennessee, 37067, United States
Research Site
Knoxville, Tennessee, 37912, United States
Research Site
Dallas, Texas, 75254, United States
Research Site
Houston, Texas, 77081, United States
Research Site
Humble, Texas, 77346, United States
Research Site
Irving, Texas, 75063, United States
Research Site
Sandy City, Utah, 84070, United States
Research Site
Midlothian, Virginia, 23112, United States
Research Site
Morgantown, West Virginia, 26501, United States
Research Site
Buenos Aires, 1061, Argentina
Research Site
Buenos Aires, C1425AGC, Argentina
Research Site
CABA, 1056, Argentina
Research Site
CABA, C1120AAC, Argentina
Research Site
Caba, C1128AAF, Argentina
Research Site
Capital Federal, C1014A, Argentina
Research Site
Granadero Baigorria, S2152BOF, Argentina
Research Site
Lanus, B1824KAJ, Argentina
Research Site
Rosario, 2000, Argentina
Research Site
Rosario, S2000CVD, Argentina
Research Site
San Nicolás, B2900DMH, Argentina
Research Site
San Vicente, 5006, Argentina
Research Site
Botany, 2019, Australia
Research Site
Camberwell, 3124, Australia
Research Site
Kotara, 2289, Australia
Research Site
Maroubra, 2035, Australia
Research Site
St Albans, 3021, Australia
Research Site
St Leonards, 2065, Australia
Research Site
Belém, 66073-005, Brazil
Research Site
Brasília, 72145-450, Brazil
Research Site
Campinas, 13060-080, Brazil
Research Site
Campinas, 13092133, Brazil
Research Site
Curitiba, 80045-170, Brazil
Research Site
Fortaleza, 60430-350, Brazil
Research Site
Porto Alegre, 90430-001, Brazil
Research Site
São José dos Campos, 12230-001, Brazil
Research Site
São Paulo, 01228-000, Brazil
Research Site
São Paulo, 01236-030, Brazil
Research Site
São Paulo, 04012-180, Brazil
Research Site
Calgary, Alberta, T2V 4J2, Canada
Research Site
Calgary, Alberta, T3R 1W9, Canada
Research Site
Vancouver, British Columbia, V5Y 3W2, Canada
Research Site
Victoria, British Columbia, V8V 4A1, Canada
Research Site
Moncton, New Brunswick, E1G 1A7, Canada
Research Site
Truro, Nova Scotia, B2N 1L2, Canada
Research Site
Brampton, Ontario, L6T 0G1, Canada
Research Site
Hamilton, Ontario, L8L 5G8, Canada
Research Site
Niagara Falls, Ontario, L2H 1H5, Canada
Research Site
North York, Ontario, M6B 3H7, Canada
Research Site
Sarnia, Ontario, N7T 4X3, Canada
Research Site
Scarborough Village, Ontario, M1R 0B1, Canada
Research Site
Stouffville, Ontario, L4A1H2, Canada
Research Site
Toronto, Ontario, M3J 0K2, Canada
Research Site
Toronto, Ontario, M6G 1M2, Canada
Research Site
Toronto, Ontario, M9V 4B4, Canada
Research Site
Joliette, Quebec, J6E 6A9, Canada
Research Site
Montreal, Quebec, H4N 2W2, Canada
Research Site
Saint-Lambert, Quebec, J4P 2H4, Canada
Research Site
Terrebonne, Quebec, J6X 4P7, Canada
Research Site
Araucania, 4781151, Chile
Research Site
Concepción, 4070196, Chile
Research Site
Las Condes, 7560908, Chile
Research Site
Osorno, 5311092, Chile
Research Site
Providencia, 7500504, Chile
Research Site
Santiago, 7510187, Chile
Research Site
Santiago, 7691236, Chile
Research Site
Santiago, 8330034, Chile
Research Site
Santiago, 8331143, Chile
Research Site
Temuco, 4810345, Chile
Research Site
Binzhou, 256603, China
Research Site
Chengdu, 610078, China
Research Site
Chengdu, 610081, China
Research Site
Deyang, 618000, China
Research Site
Ganzhou, 341099, China
Research Site
Guangzhou, 510220, China
Research Site
Guangzhou, 510280, China
Research Site
Haikou, 570208, China
Research Site
Hangzhou, 310006, China
Research Site
Hangzhou, 311200, China
Research Site
Huaian, 223300, China
Research Site
Huzhou, 313003, China
Research Site
Jinan, 250001, China
Research Site
Jinzhou, 121002, China
Research Site
Kunming, CN-650034, China
Research Site
Lanzhou, 730000, China
Research Site
Linhai, 317000, China
Research Site
Liuzhou, 545006, China
Research Site
Luoyang, 471001, China
Research Site
Nanchang, 330006, China
Research Site
Nanjing, 210006, China
Research Site
Nanjing, 211100, China
Research Site
Nantong, 226001, China
Research Site
Ningbo, 315000, China
Research Site
Panjin, 124000, China
Research Site
Pingxiang, 337055, China
Research Site
Qingdao, 266035, China
Research Site
Shanghai, 200025, China
Research Site
Shanghai, 201200, China
Research Site
Shenyang, 110016, China
Research Site
Shenzhen, 518036, China
Research Site
Siping, 136000, China
Research Site
Suining, 629000, China
Research Site
Suzhou, 215006, China
Research Site
Ürümqi, 831118, China
Research Site
Wanzhou, 404000, China
Research Site
Wenzhou, 325000, China
Research Site
Wuhan, 430030, China
Research Site
Wuxi, 214023, China
Research Site
Xiangfan, 441021, China
Research Site
Xuancheng, 242000, China
Research Site
Yibin, 644000, China
Research Site
Yichang, 443003, China
Research Site
Zhengzhou, 450002, China
Research Site
Zhenjiang, 212002, China
Research Site
Zunyi, 563100, China
Research Site
Bad Oeynhausen, 32545, Germany
Research Site
Bochum, 44789, Germany
Research Site
Cologne, 50937, Germany
Research Site
Cologne, 51069, Germany
Research Site
Dresden, 01307, Germany
Research Site
Falkensee, 14612, Germany
Research Site
Gera, 07548, Germany
Research Site
Hamburg, 22607, Germany
Research Site
Leipzig, 04103, Germany
Research Site
Leipzig, 04107, Germany
Research Site
Lübeck, 23562, Germany
Research Site
Mainz, 55131, Germany
Research Site
Mannheim, 68167, Germany
Research Site
München, 80809, Germany
Research Site
Münster, 48145, Germany
Research Site
Nuremberg, 90443, Germany
Research Site
Obertshausen, 63179, Germany
Research Site
Oldenburg, 23758, Germany
Research Site
Stuttgart, 70199, Germany
Research Site
Ulm, 89073, Germany
Research Site
Wangen, 88239, Germany
Research Site
Würzburg, 97080, Germany
Research Site
Bangalore, 560 092, India
Research Site
Belagavi, 590006, India
Research Site
Bikaner, 334001, India
Research Site
Delhi, 110029, India
Research Site
Guntur, 522001, India
Research Site
Hyderabad, 500034, India
Research Site
Jodhpur, 342005, India
Research Site
Kolkata, 700014, India
Research Site
Kolkata, 700020, India
Research Site
Madurai, 625020, India
Research Site
Mumbai, 400008, India
Research Site
Mumbai, 400012, India
Research Site
Mysore, 570001, India
Research Site
Nagpur, 440010, India
Research Site
New Delhi, 110002, India
Research Site
Siliguri, 734012, India
Research Site
Bologna, 40138, Italy
Research Site
Catania, 95123, Italy
Research Site
Chieti, 66100, Italy
Research Site
Florence, 50134, Italy
Research Site
Latina, 04100, Italy
Research Site
Milan, 20154, Italy
Research Site
Pisa, 56100, Italy
Research Site
Ravenna, 48121, Italy
Research Site
Roma, 00128, Italy
Research Site
Roma, 161, Italy
Research Site
San Donato, 20097, Italy
Research Site
Amagasaki-shi, 660-0861, Japan
Research Site
Chūōku, 103-0002, Japan
Research Site
Chūōku, 1040031, Japan
Research Site
Kasugai-shi, 486-8510, Japan
Research Site
Koga-shi, 306-0232, Japan
Research Site
Maebashi, 371-8511, Japan
Research Site
Minatoku, 105-0004, Japan
Research Site
Minatoku, 108-0073, Japan
Research Site
Naka, 311-0113, Japan
Research Site
Shinjuku-ku, 169-0072, Japan
Research Site
Shizuoka, 424-0855, Japan
Research Site
Suita-shi, 564-8565, Japan
Research Site
Suita-shi, 565-0853, Japan
Research Site
Toshima-ku, 171-0014, Japan
Research Site
Yamato-shi, 242-0004, Japan
Research Site
Yokohama, 230-8765, Japan
Research Site
Yokohama, 232-0064, Japan
Research Site
Bialystok, 15-375, Poland
Research Site
Bialystok, 15-435, Poland
Research Site
Bydgoszcz, 85-796, Poland
Research Site
Kielce, 25-355, Poland
Research Site
Krakow, 30-727, Poland
Research Site
Krakow, 31-261, Poland
Research Site
Krakow, 31-271, Poland
Research Site
Lodz, 90-338, Poland
Research Site
Lublin, 20-064, Poland
Research Site
Lublin, 20-718, Poland
Research Site
Poznan, 60-354, Poland
Research Site
Poznan, 60-589, Poland
Research Site
Radom, 26-600, Poland
Research Site
Warsaw, 00-124, Poland
Research Site
Warsaw, 02-507, Poland
Research Site
Warsaw, 02-758, Poland
Research Site
Al-Ahsa, 36428, Saudi Arabia
Research Site
Dammam, 31444, Saudi Arabia
Research Site
Jeddah, 22384, Saudi Arabia
Research Site
Khobar, 31952, Saudi Arabia
Research Site
Riyadh, 11462, Saudi Arabia
Research Site
Riyadh, 12713, Saudi Arabia
Research Site
Bellville, 7530, South Africa
Research Site
Bloemfontein, 9301, South Africa
Research Site
Cape Town, 7500, South Africa
Research Site
Cape Town, 7764, South Africa
Research Site
Chatsworth, 4092, South Africa
Research Site
Claremont, 7708, South Africa
Research Site
Durban, 4091, South Africa
Research Site
eMkhomazi, 4170, South Africa
Research Site
Johannesburg, 1827, South Africa
Research Site
Johannesburg, 2113, South Africa
Research Site
Midrand, 1685, South Africa
Research Site
Wentworth, 4032, South Africa
Research Site
Busan, 49201, South Korea
Research Site
Busan, 49241, South Korea
Research Site
Daegu, 42415, South Korea
Research Site
Goyang-si, 13620, South Korea
Research Site
Gyeonggi-do, 13620, South Korea
Research Site
Incheon, 21565, South Korea
Research Site
Jongno-gu, 110-746, South Korea
Research Site
Seoul, 02447, South Korea
Research Site
Seoul, 120-752, South Korea
Research Site
Suwon, 443-721, South Korea
Research Site
A Coruña, 15006, Spain
Research Site
Almería, 04009, Spain
Research Site
Badalona, 08916, Spain
Research Site
Barcelona, 08036, Spain
Research Site
Barcelona, 08041, Spain
Research Site
Barcelona, 8035, Spain
Research Site
León, 24008, Spain
Research Site
Madrid, 28006, Spain
Research Site
Santander, 39008, Spain
Research Site
Santiago de Compostela, 15706, Spain
Research Site
Seville, 41003, Spain
Research Site
Seville, 41013, Spain
Research Site
Seville, 41950, Spain
Research Site
Tarragona, 43007, Spain
Research Site
Valencia, 46014, Spain
Research Site
Changhua, 500, Taiwan
Research Site
Kaohsiung City, 807, Taiwan
Research Site
Taichung, 402, Taiwan
Research Site
Taichung, 40447, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Taichung, 433004, Taiwan
Research Site
Tainan, 704, Taiwan
Research Site
Tainan County, 71044, Taiwan
Research Site
Taipei, 10002, Taiwan
Research Site
Taipei, 110, Taiwan
Research Site
Adana, 01060, Turkey (Türkiye)
Research Site
Adana, 01120, Turkey (Türkiye)
Research Site
Adapazarı, 54290, Turkey (Türkiye)
Research Site
Ankara, 06530, Turkey (Türkiye)
Research Site
Ankara, 5000, Turkey (Türkiye)
Research Site
Ankara, 6230, Turkey (Türkiye)
Research Site
Antalya, 07059, Turkey (Türkiye)
Research Site
Istanbul, 34098, Turkey (Türkiye)
Research Site
Istanbul, 34384, Turkey (Türkiye)
Research Site
Istanbul, 34722, Turkey (Türkiye)
Research Site
Ashton-under-Lyne, OL6 6EW, United Kingdom
Research Site
Blackpool, FY3 7EN, United Kingdom
Research Site
Chesterfield, S40 4AA, United Kingdom
Research Site
Corby, NN17 2UR, United Kingdom
Research Site
Ely, CB7 5JD, United Kingdom
Research Site
Glasgow, G51 4TF, United Kingdom
Research Site
Hounslow, TW3 3LN, United Kingdom
Research Site
Leicester, Le5 4PW, United Kingdom
Research Site
Metropolitan Borough of Wirral, CH48 5AA, United Kingdom
Research Site
Poole, BH16 5PW, United Kingdom
Research Site
Rotherham, S65 1DA, United Kingdom
Research Site
Stowmarket, IP142SY, United Kingdom
Research Site
Wansford, PE8 6PL, United Kingdom
Research Site
Witney, OX28 6JS, United Kingdom
Research Site
Yate, BS37 4AX, United Kingdom
Study Officials
- 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
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2026
First Posted
June 25, 2026
Study Start
June 29, 2026
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
July 30, 2029
Last Updated
July 10, 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.