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

July 9, 2026 updated by: AstraZeneca

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

Recruiting

Conditions

Weight Management

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Number of Arms

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 Time Frame: 72 weeks	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 Time Frame: 72 weeks	Absolute change from baseline to Week 72 in body weight (kg)	72 weeks
Total body weight loss of at least 5%, 10%, and 15% Time Frame: 72 weeks	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 Time Frame: 72 weeks	Percent change from baseline to Week 72 in body weight	72 weeks
Waist circumference reduction Time Frame: 72 weeks	Absolute change from baseline to Week 72 in waist circumference (cm)	72 weeks
Glycemic control Time Frame: 72 weeks	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 Time Frame: 72 weeks	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 Time Frame: 72 weeks	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 Time Frame: 72 weeks	Change from baseline to Week 72 in systolic blood pressure (mmHg)	72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 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)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 9, 2026

Last Verified

July 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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