A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM (Embold)
September 7, 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
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
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Buenos Aires, Argentina, C1425AGC
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Buenos Aires, Argentina, C1120AAC
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CABA, Argentina, C1061
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CABA, Argentina, 1056
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Caba, Argentina, C1128AAF
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Capital Federal, Argentina, C1014A
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Granadero Baigorria, Argentina, S2152BOF
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Lanus, Argentina, B1824KAJ
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Rosario, Argentina, 2000
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Rosario, Argentina, S2000CVD
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San Nicolás, Argentina, B2900DMH
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San Vicente, Argentina, 5006
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Botany, Australia, 2019
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Camberwell, Australia, 3124
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Charlestown, Australia, 2290
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Maroubra, Australia, 2035
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St Albans, Australia, 3021
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St Leonards, Australia, 2065
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Belém, Brazil, 66073-005
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Brasília, Brazil, 72145-450
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Campinas, Brazil, 13060-080
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Campinas, Brazil, 13092133
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Curitiba, Brazil, 80045-170
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Fortaleza, Brazil, 60426-000
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Porto Alegre, Brazil, 90430-001
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São José dos Campos, Brazil, 12230-001
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São Paulo, Brazil, 04012-180
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São Paulo, Brazil, 01236-030
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São Paulo, Brazil, 01228-000
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Alberta
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Calgary, Alberta, Canada, T2V 4J2
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Calgary, Alberta, Canada, T3R 1W9
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British Columbia
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Vancouver, British Columbia, Canada, V5Y 3W2
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Victoria, British Columbia, Canada, V8V 4A1
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New Brunswick
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Moncton, New Brunswick, Canada, E1G 1A7
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Nova Scotia
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Truro, Nova Scotia, Canada, B2N 1L2
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Ontario
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Brampton, Ontario, Canada, L6T 0G1
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Hamilton, Ontario, Canada, L8L 5G8
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Niagara Falls, Ontario, Canada, L2H 1H5
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North York, Ontario, Canada, M6B 3H7
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Sarnia, Ontario, Canada, N7T 4X3
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Scarborough Village, Ontario, Canada, M1R 0B1
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Stouffville, Ontario, Canada, L4A1H2
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Toronto, Ontario, Canada, M9V 4B4
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Toronto, Ontario, Canada, M6G 1M2
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Toronto, Ontario, Canada, M3J 0K2
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Quebec
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Joliette, Quebec, Canada, J6E 6A9
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Montreal, Quebec, Canada, H4N 2W2
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Saint-Lambert, Quebec, Canada, J4P 1S9
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Terrebonne, Quebec, Canada, J6X 4P7
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Araucania, Chile, 4781151
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Concepción, Chile, 4070196
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Osorno, Chile, 5311092
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Providencia, Chile, 7500504
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Santiago, Chile, 8330034
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Santiago, Chile, 7691236
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Santiago, Chile, 8331143
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Santiago, Chile, 7510187
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Santiago, Chile, 7560938
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Temuco, Chile, 4810345
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Binzhou, China, 256603
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Chengdu, China, 610078
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Chengdu, China, 610081
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Deyang, China, 618000
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Ganzhou, China, 341000
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Guangzhou, China, 510280
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Guangzhou, China, 510220
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Haikou, China, 570208
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Hangzhou, China, 310006
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Hangzhou, China, 311200
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Huaian, China, 223300
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Huzhou, China, 313003
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Jinan, China, 250001
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Jinzhou, China, 121002
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Kunming, China, CN-650034
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Lanzhou, China, 730000
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Linhai, China, 317000
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Liuzhou, China, 545006
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Luoyang, China, 471001
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Nanchang, China, 330006
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Nanjing, China, 210006
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Nanjing, China, 211100
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Nantong, China, 226316
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Ningbo, China, 315000
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Panjin, China, 124000
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Pingxiang, China, 337055
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Qingdao, China, 266035
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Shanghai, China, 200025
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Shanghai, China, 200080
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Shanghai, China, 201200
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Shenyang, China, 110016
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Shenzhen, China, 518036
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Siping, China, 136000
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Suining, China, 629000
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Suzhou, China, 215006
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Wanzhou, China, 404000
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Wenzhou, China, 325000
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Wuhan, China, 430030
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Wuxi, China, 214023
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Xiangyang, China, 441021
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Xuancheng, China, 242000
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Yibin, China, 644000
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Yichang, China, 443003
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Zhengzhou, China, 450002
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Zhenjiang, China, 212002
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Zunyi, China, 563100
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Ürümqi, China, 830001
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Bad Oeynhausen, Germany, 32545
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Bochum, Germany, 44789
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Cologne, Germany, 50937
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Cologne, Germany, 51069
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Dresden, Germany, 01307
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Falkensee, Germany, 14612
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Gera, Germany, 07548
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Hamburg, Germany, 22607
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Leipzig, Germany, 04103
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Leipzig, Germany, 04107
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Lübeck, Germany, 23562
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Mainz, Germany, 55131
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Mannheim, Germany, 68167
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München, Germany, 80809
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Münster, Germany, 48145
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Nuremberg, Germany, 90443
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Obertshausen, Germany, 63179
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Oldenburg, Germany, 23758
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Stuttgart, Germany, 70199
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Ulm, Germany, 89073
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Wangen, Germany, 88239
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Würzburg, Germany, 97080
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Bangalore, India, 560 092
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Belagavi, India, 590006
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Bikaner, India, 334001
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Delhi, India, 110029
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Guntur, India, 522001
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Hyderabad, India, 500034
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Jaipur, India, 302017
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Jodhpur, India, 342005
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Kolkata, India, 700020
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Kolkata, India, 700014
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Madurai, India, 625020
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Mumbai, India, 400012
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Mumbai, India, 400008
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Mysore, India, 570001
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Nagpur, India, 440010
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New Delhi, India, 110002
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Siliguri, India, 734012
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Bologna, Italy, 40138
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Catania, Italy, 95123
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Chieti, Italy, 66100
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Florence, Italy, 50134
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Latina, Italy, 04100
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Milan, Italy, 20154
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Pisa, Italy, 56100
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Ravenna, Italy, 48121
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Roma, Italy, 00128
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Roma, Italy, 161
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San Donato, Italy, 20097
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Amagasaki-shi, Japan, 660-0861
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Chūōku, Japan, 103-0002
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Chūōku, Japan, 1040031
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Kasugai-shi, Japan, 486-8510
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Koga-shi, Japan, 306-0232
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Maebashi, Japan, 371-8511
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Minatoku, Japan, 108-0073
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Minatoku, Japan, 105-0004
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Naka, Japan, 311-0113
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Shinjuku-ku, Japan, 169-0072
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Shizuoka, Japan, 424-0855
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Suita-shi, Japan, 564-8565
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Suita-shi, Japan, 565-0853
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Toshima-ku, Japan, 171-0014
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Yamato-shi, Japan, 242-0004
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Yokohama, Japan, 232-0064
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Yokohama, Japan, 230-8765
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Bialystok, Poland, 15-375
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Bialystok, Poland, 15-435
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Bydgoszcz, Poland, 85-796
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Kielce, Poland, 25-355
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Krakow, Poland, 30-727
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Krakow, Poland, 31-261
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Krakow, Poland, 31-271
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Lodz, Poland, 90-338
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Lublin, Poland, 20-718
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Lublin, Poland, 20-064
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Poznan, Poland, 60-354
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Poznan, Poland, 60-589
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Radom, Poland, 26-600
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Warsaw, Poland, 02-507
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Warsaw, Poland, 00-124
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Warsaw, Poland, 02-758
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Al-Ahsa, Saudi Arabia, 36428
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Dammam, Saudi Arabia, 31444
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Jeddah, Saudi Arabia, 22384
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Khobar, Saudi Arabia, 31952
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Riyadh, Saudi Arabia, 12713
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Riyadh, Saudi Arabia, 11462
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Bellville, South Africa, 7530
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Bloemfontein, South Africa, 9301
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Cape Town, South Africa, 7500
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Cape Town, South Africa, 7764
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Chatsworth, South Africa, 4092
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Claremont, South Africa, 7708
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Durban, South Africa, 4091
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Johannesburg, South Africa, 1827
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Johannesburg, South Africa, 2113
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Midrand, South Africa, 1685
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Wentworth, South Africa, 4032
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eMkhomazi, South Africa, 4170
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Busan, South Korea, 49241
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Busan, South Korea, 49201
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Daegu, South Korea, 42415
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Daegu, South Korea, 41404
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Goyang-si, South Korea, 13620
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Gyeonggi-do, South Korea, 13620
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Incheon, South Korea, 21565
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Jongno-gu, South Korea, 110-746
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Seoul, South Korea, 120-752
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Seoul, South Korea, 02447
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Suwon, South Korea, 443-721
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A Coruña, Spain, 15006
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Almería, Spain, 04009
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Badalona, Spain, 08916
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Barcelona, Spain, 08036
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Barcelona, Spain, 8035
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Barcelona, Spain, 08041
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León, Spain, 24008
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Madrid, Spain, 28006
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Santander, Spain, 39008
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Santiago de Compostela, Spain, 15706
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Seville, Spain, 41013
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Seville, Spain, 41950
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Seville, Spain, 41003
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Tarragona, Spain, 43007
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Valencia, Spain, 46014
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Changhua, Taiwan, 500
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Kaohsiung City, Taiwan, 807
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Taichung, Taiwan, 40447
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Taichung, Taiwan, 40705
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Taichung, Taiwan, 402
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Taichung, Taiwan, 433004
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Tainan, Taiwan, 704
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Tainan County, Taiwan, 71044
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 110
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Adana, Turkey (Türkiye), 01060
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Adana, Turkey (Türkiye), 01120
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Adapazarı, Turkey (Türkiye), 54290
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Ankara, Turkey (Türkiye), 06530
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Ankara, Turkey (Türkiye), 5000
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Ankara, Turkey (Türkiye), 6230
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Antalya, Turkey (Türkiye), 07059
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Istanbul, Turkey (Türkiye), 34098
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Istanbul, Turkey (Türkiye), 34722
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Istanbul, Turkey (Türkiye), 34384
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Ashton-under-Lyne, United Kingdom, OL6 6EW
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Blackpool, United Kingdom, FY3 7EN
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Chesterfield, United Kingdom, S40 4AA
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Corby, United Kingdom, NN17 2UR
- Withdrawn
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Ely, United Kingdom, CB7 5JD
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Glasgow, United Kingdom, G51 4TF
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Hounslow, United Kingdom, TW4 7NJ
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Leicester, United Kingdom, Le5 4PW
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Metropolitan Borough of Wirral, United Kingdom, CH48 5AA
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Nantwich, United Kingdom, CW5 5NX
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Poole, United Kingdom, BH16 5PW
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Rotherham, United Kingdom, S65 1DA
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Stowmarket, United Kingdom, IP142SY
- Withdrawn
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Wansford, United Kingdom, PE8 6PL
- Withdrawn
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Witney, United Kingdom, OX28 6JS
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Yate, United Kingdom, BS37 4AX
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Alabama
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Birmingham, Alabama, United States, 35205
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Dothan, Alabama, United States, 36305
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Arizona
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Chandler, Arizona, United States, 85225
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Sun City, Arizona, United States, 85373
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Arkansas
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Little Rock, Arkansas, United States, 72205
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California
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Lynwood, California, United States, 90262
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Rolling Hills Estates, California, United States, 90274
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Sacramento, California, United States, 95821
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Colorado
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Arvada, Colorado, United States, 80002
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Connecticut
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New Haven, Connecticut, United States, 06519
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Florida
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Plantation, Florida, United States, 33324
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Tampa, Florida, United States, 33606
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Georgia
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Woodstock, Georgia, United States, 30189
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Idaho
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Ammon, Idaho, United States, 83406
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Illinois
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Melrose Park, Illinois, United States, 60160
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Indiana
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Indianapolis, Indiana, United States, 46254
- Not yet recruiting
- Research Site
-
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Kansas
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Wichita, Kansas, United States, 67218
- Not yet recruiting
- Research Site
-
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Kentucky
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Louisville, Kentucky, United States, 40213
- Recruiting
- Research Site
-
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Louisiana
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Alexandria, Louisiana, United States, 71303
- Recruiting
- Research Site
-
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Maryland
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Baltimore, Maryland, United States, 21229
- Not yet recruiting
- Research Site
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Potomac, Maryland, United States, 20854
- Recruiting
- Research Site
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White Marsh, Maryland, United States, 21162
- Recruiting
- Research Site
-
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Michigan
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Ypsilanti, Michigan, United States, 48197
- Withdrawn
- Research Site
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Mississippi
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Ridgeland, Mississippi, United States, 39157
- Not yet recruiting
- Research Site
-
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Missouri
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Kansas City, Missouri, United States, 64114
- Recruiting
- Research Site
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St Louis, Missouri, United States, 63123
- Not yet recruiting
- Research Site
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Nevada
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Reno, Nevada, United States, 89511
- Not yet recruiting
- Research Site
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- Not yet recruiting
- Research Site
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New York
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Albany, New York, United States, 12205
- Not yet recruiting
- Research Site
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Laurelton, New York, United States, 11413
- Recruiting
- Research Site
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Long Island City, New York, United States, 11106
- Recruiting
- Research Site
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North Carolina
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Greensboro, North Carolina, United States, 27408
- Recruiting
- Research Site
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Raleigh, North Carolina, United States, 27609
- Recruiting
- Research Site
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Rocky Mount, North Carolina, United States, 27804
- Not yet recruiting
- Research Site
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Statesville, North Carolina, United States, 28625
- Recruiting
- Research Site
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Ohio
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Columbus, Ohio, United States, 43228
- Recruiting
- Research Site
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Dayton, Ohio, United States, 45424
- Recruiting
- Research Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73134
- Not yet recruiting
- Research Site
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Tulsa, Oklahoma, United States, 74133
- Recruiting
- Research Site
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Oregon
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Portland, Oregon, United States, 97223
- Not yet recruiting
- Research Site
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Pennsylvania
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DuBois, Pennsylvania, United States, 15801
- Recruiting
- Research Site
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Newport, Pennsylvania, United States, 17074
- Not yet recruiting
- Research Site
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Philadelphia, Pennsylvania, United States, 19104
- Not yet recruiting
- Research Site
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Rhode Island
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East Providence, Rhode Island, United States, 02914
- Not yet recruiting
- Research Site
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South Carolina
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Charleston, South Carolina, United States, 29407
- Recruiting
- Research Site
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Gaffney, South Carolina, United States, 29340
- Recruiting
- Research Site
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Not yet recruiting
- Research Site
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Tennessee
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Franklin, Tennessee, United States, 37067
- Not yet recruiting
- Research Site
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Knoxville, Tennessee, United States, 37912
- Not yet recruiting
- Research Site
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Texas
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Dallas, Texas, United States, 75254
- Recruiting
- Research Site
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Houston, Texas, United States, 77081
- Not yet recruiting
- Research Site
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Humble, Texas, United States, 77346
- Not yet recruiting
- Research Site
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Irving, Texas, United States, 75063
- Recruiting
- Research Site
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Utah
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Sandy City, Utah, United States, 84070
- Not yet recruiting
- Research Site
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Virginia
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Midlothian, Virginia, United States, 23112
- Not yet recruiting
- Research Site
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West Virginia
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Morgantown, West Virginia, United States, 26501
- Not yet recruiting
- Research Site
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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
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
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1 - Dose 1
Active IMP
|
Elecoglipron film-coated tablet once daily
Other Names:
|
|
Experimental: Arm 2 - Dose 2
Active IMP
|
Elecoglipron film-coated tablet once daily
Other Names:
|
|
Placebo Comparator: Arm 3 - Placebo
Placebo matching elecoglipron
|
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
|
|
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
|
|
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
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)
September 9, 2026
Last Update Submitted That Met QC Criteria
September 7, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- D7260C00015
- 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 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
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.