Weight ManagementPhase 3EmboldNCT07667803
A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM
A Phase 3 study testing Elecoglipron in people with Weight Management, run by AstraZeneca at 325 sites in 19 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Management
- What is being tested?
- Elecoglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,500 participants
- Where
- 325 sitesin 19 countries
- Study dates
- 29 Jun 2026to 30 Jul 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
325 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
325 sites in 19 countries
United States56 sites, 55 recruiting
- Not yet recruiting
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Albany, New York, 12205
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Albuquerque, New Mexico, 87106
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Alexandria, Louisiana, 71303
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Ammon, Idaho, 83406
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Arvada, Colorado, 80002
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Baltimore, Maryland, 21229
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Birmingham, Alabama, 35205
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Chandler, Arizona, 85225
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Charleston, South Carolina, 29407
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Columbus, Ohio, 43228
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Dallas, Texas, 75254
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Dayton, Ohio, 45424
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Dothan, Alabama, 36305
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DuBois, Pennsylvania, 15801
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East Providence, Rhode Island, 02914
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Franklin, Tennessee, 37067
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Gaffney, South Carolina, 29340
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Greensboro, North Carolina, 27408
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Houston, Texas, 77081
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Humble, Texas, 77346
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Indianapolis, Indiana, 46254
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Irving, Texas, 75063
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Kansas City, Missouri, 64114
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Knoxville, Tennessee, 37912
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Laurelton, New York, 11413
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Little Rock, Arkansas, 72205
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Long Island City, New York, 11106
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Louisville, Kentucky, 40213
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Lynwood, California, 90262
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Melrose Park, Illinois, 60160
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Midlothian, Virginia, 23112
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Morgantown, West Virginia, 26501
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New Haven, Connecticut, 06519
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Newport, Pennsylvania, 17074
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Oklahoma City, Oklahoma, 73134
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Philadelphia, Pennsylvania, 19104
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Plantation, Florida, 33324
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Portland, Oregon, 97223
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Potomac, Maryland, 20854
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Raleigh, North Carolina, 27609
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Rapid City, South Dakota, 57701
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Reno, Nevada, 89511
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Ridgeland, Mississippi, 39157
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Rocky Mount, North Carolina, 27804
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Rolling Hills Estates, California, 90274
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Sacramento, California, 95821
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Sandy City, Utah, 84070
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St Louis, Missouri, 63123
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Statesville, North Carolina, 28625
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Sun City, Arizona, 85373
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Tampa, Florida, 33606
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Tulsa, Oklahoma, 74133
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White Marsh, Maryland, 21162
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Wichita, Kansas, 67218
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Woodstock, Georgia, 30189
- Withdrawn
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Ypsilanti, Michigan, 48197
China47 sites, 46 recruiting
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Binzhou, 256603
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Chengdu, 610078
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Chengdu, 610081
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Deyang, 618000
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Ganzhou, 341000
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Guangzhou, 510220
- Withdrawn
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Guangzhou, 510280
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Haikou, 570208
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Hangzhou, 310006
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Hangzhou, 311200
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Huaian, 223300
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Huzhou, 313003
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Jinan, 250001
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Jinzhou, 121002
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Kunming, CN-650034
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Lanzhou, 730000
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Linhai, 317000
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Liuzhou, 545006
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Luoyang, 471001
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Nanchang, 330006
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Nanjing, 210006
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Nanjing, 211100
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Nantong, 226316
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Ningbo, 315000
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Panjin, 124000
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Pingxiang, 337055
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Qingdao, 266035
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Shanghai, 200025
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Shanghai, 200080
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Shanghai, 201200
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Shenyang, 110016
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Shenzhen, 518036
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Siping, 136000
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Suining, 629000
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Suzhou, 215006
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Ürümqi, 830001
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Wanzhou, 404000
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Wenzhou, 325000
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Wuhan, 430030
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Wuxi, 214023
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Xiangyang, 441021
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Xuancheng, 242000
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Yibin, 644000
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Yichang, 443003
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Zhengzhou, 450002
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Zhenjiang, 212002
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Zunyi, 563100
Germany22 sites, 22 recruiting
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Bad Oeynhausen, 32545
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Bochum, 44789
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Cologne, 50937
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Cologne, 51069
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Dresden, 01307
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Falkensee, 14612
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Gera, 07548
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Hamburg, 22607
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Leipzig, 04103
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Leipzig, 04107
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Lübeck, 23562
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Mainz, 55131
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Mannheim, 68167
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München, 80809
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Münster, 48145
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Nuremberg, 90443
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Obertshausen, 63179
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Oldenburg, 23758
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Stuttgart, 70199
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Ulm, 89073
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Wangen, 88239
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Würzburg, 97080
Canada20 sites, 20 recruiting
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Brampton, Ontario, L6T 0G1
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Calgary, Alberta, T2V 4J2
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Calgary, Alberta, T3R 1W9
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Hamilton, Ontario, L8L 5G8
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Joliette, Quebec, J6E 6A9
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Moncton, New Brunswick, E1G 1A7
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Montreal, Quebec, H4N 2W2
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Niagara Falls, Ontario, L2H 1H5
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North York, Ontario, M6B 3H7
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Saint-Lambert, Quebec, J4P 1S9
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Sarnia, Ontario, N7T 4X3
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Scarborough Village, Ontario, M1R 0B1
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Stouffville, Ontario, L4A1H2
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Terrebonne, Quebec, J6X 4P7
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Toronto, Ontario, M3J 0K2
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Toronto, Ontario, M6G 1M2
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Toronto, Ontario, M9V 4B4
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Truro, Nova Scotia, B2N 1L2
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Vancouver, British Columbia, V5Y 3W2
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Victoria, British Columbia, V8V 4A1
India17 sites, 14 recruiting
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Bangalore, 560 092
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Belagavi, 590006
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Bikaner, 334001
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Delhi, 110029
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Guntur, 522001
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Hyderabad, 500034
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Jaipur, 302017
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Jodhpur, 342005
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Kolkata, 700014
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Kolkata, 700020
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Madurai, 625020
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Mumbai, 400008
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Mumbai, 400012
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Mysore, 570001
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Nagpur, 440010
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New Delhi, 110002
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Siliguri, 734012
Japan17 sites, 17 recruiting
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Amagasaki-shi, 660-0861
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Chūōku, 103-0002
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Chūōku, 1040031
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Kasugai-shi, 486-8510
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Koga-shi, 306-0232
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Maebashi, 371-8511
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Minatoku, 105-0004
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Minatoku, 108-0073
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Naka, 311-0113
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Shinjuku-ku, 169-0072
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Shizuoka, 424-0855
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Suita-shi, 564-8565
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Suita-shi, 565-0853
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Toshima-ku, 171-0014
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Yamato-shi, 242-0004
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Yokohama, 230-8765
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Yokohama, 232-0064
Poland16 sites, 16 recruiting
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Bialystok, 15-375
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Bialystok, 15-435
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Bydgoszcz, 85-796
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Kielce, 25-355
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Krakow, 30-727
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Krakow, 31-261
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Krakow, 31-271
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Lodz, 90-338
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Lublin, 20-064
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Lublin, 20-718
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Poznan, 60-354
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Poznan, 60-589
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Radom, 26-600
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Warsaw, 00-124
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Warsaw, 02-507
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Warsaw, 02-758
United Kingdom16 sites, 13 recruiting
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Ashton-under-Lyne, OL6 6EW
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Blackpool, FY3 7EN
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Chesterfield, S40 4AA
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Corby, NN17 2UR
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Ely, CB7 5JD
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Glasgow, G51 4TF
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Hounslow, TW4 7NJ
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Leicester, Le5 4PW
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Metropolitan Borough of Wirral, CH48 5AA
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Nantwich, CW5 5NX
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Poole, BH16 5PW
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Rotherham, S65 1DA
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Stowmarket, IP142SY
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Wansford, PE8 6PL
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Witney, OX28 6JS
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Yate, BS37 4AX
Spain15 sites, 15 recruiting
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A Coruña, 15006
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Almería, 04009
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Badalona, 08916
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Barcelona, 08036
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Barcelona, 08041
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Barcelona, 8035
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León, 24008
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Madrid, 28006
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Santander, 39008
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Santiago de Compostela, 15706
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Seville, 41003
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Seville, 41013
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Seville, 41950
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Tarragona, 43007
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Valencia, 46014
Argentina12 sites, 12 recruiting
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Buenos Aires, C1120AAC
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Buenos Aires, C1425AGC
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Caba, C1128AAF
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CABA, 1056
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CABA, C1061
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Capital Federal, C1014A
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Granadero Baigorria, S2152BOF
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Lanus, B1824KAJ
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Rosario, 2000
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Rosario, S2000CVD
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San Nicolás, B2900DMH
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San Vicente, 5006
South Africa12 sites, 12 recruiting
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Bellville, 7530
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Bloemfontein, 9301
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Cape Town, 7500
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Cape Town, 7764
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Chatsworth, 4092
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Claremont, 7708
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Durban, 4091
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eMkhomazi, 4170
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Johannesburg, 1827
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Johannesburg, 2113
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Midrand, 1685
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Wentworth, 4032
Brazil11 sites, 11 recruiting
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Belém, 66073-005
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Brasília, 72145-450
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Campinas, 13060-080
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Campinas, 13092133
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Curitiba, 80040-110
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Fortaleza, 60426-000
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Porto Alegre, 90430-001
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São José dos Campos, 12230-001
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São Paulo, 01228-000
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São Paulo, 01236-030
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São Paulo, 04012-180
Italy11 sites, 11 recruiting
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Bologna, 40138
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Catania, 95123
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Chieti, 66100
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Florence, 50134
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Latina, 04100
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Milan, 20154
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Pisa, 56100
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Ravenna, 48121
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Roma, 00128
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Roma, 161
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San Donato, 20097
South Korea11 sites, 10 recruiting
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Busan, 49201
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Busan, 49241
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Daegu, 41404
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Daegu, 42415
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Goyang-si, 13620
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Gyeonggi-do, 13620
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Incheon, 21565
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Jongno-gu, 110-746
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Seoul, 02447
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Seoul, 120-752
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Suwon, 443-721
Chile10 sites, 10 recruiting
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Araucania, 4781151
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Concepción, 4070196
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Osorno, 5311092
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Providencia, 7500504
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Santiago, 7510187
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Santiago, 7560938
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Santiago, 7691236
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Santiago, 8330034
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Santiago, 8331143
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Temuco, 4810345
Taiwan10 sites, 10 recruiting
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Changhua, 500
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Kaohsiung City, 807
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Taichung, 402
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Taichung, 40447
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Taichung, 40705
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Taichung, 433004
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Tainan, 704
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Tainan County, 71044
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Taipei, 10002
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Taipei, 110
Turkey (Türkiye)10 sites, 10 recruiting
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Adana, 01060
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Adana, 01120
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Adapazarı, 54290
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Ankara, 06530
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Ankara, 5000
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Ankara, 6230
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Antalya, 07059
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Istanbul, 34098
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Istanbul, 34384
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Istanbul, 34722
Australia6 sites, 6 recruiting
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Botany, 2019
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Camberwell, 3124
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Charlestown, 2290
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Maroubra, 2035
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St Albans, 3021
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St Leonards, 2065
Saudi Arabia6 sites, 6 recruiting
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Al-Ahsa, 36428
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Dammam, 31444
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Jeddah, 22384
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Khobar, 31952
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Riyadh, 11462
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Riyadh, 12713
About this study
Official title: 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).
Read the 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.
- Conditions
- Weight Management
- Being tested
- Elecoglipron, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElecoglipronDrug
Also called Active IMP
Elecoglipron film-coated tablet once daily
PlaceboDrug
Placebo matching elecoglipron film-coated tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Dose 1 | Experimental | Active IMP Receives: Drug: Elecoglipron |
| Arm 2 - Dose 2 | Experimental | Active IMP Receives: Drug: Elecoglipron |
| Arm 3 - Placebo | Placebo comparator | Placebo matching elecoglipron Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent body weight loss
Percent change from baseline to Week 72 in body weight
Measured: 72 weeks
Secondary outcomes (8)
Absolute body weight loss
Absolute change from baseline to Week 72 in body weight (kg)
Measured: 72 weeks
Total body weight loss of at least 5%, 10%, and 15%
- Achieved ≥ 5% body weight loss from baseline at Week 72
- Achieved ≥ 10% body weight loss from baseline at Week 72
- Achieved ≥ 15% body weight loss from baseline at Week 72
Measured: 72 weeks
Percent body weight loss in participants with body mass index (BMI) ≥ 27 kg/m2 at baseline
Percent change from baseline to Week 72 in body weight
Measured: 72 weeks
Waist circumference reduction
Absolute change from baseline to Week 72 in waist circumference (cm)
Measured: 72 weeks
Glycemic control
Change from baseline to Week 72 in hemoglobin A1c (HbA1c) (%)
Measured: 72 weeks
Achieving normoglycemia in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline
Achieved normoglycemia (HbA1c < 5.7% [39 mmol/mol]) at Week 72
Measured: 72 weeks
Study 2 only: Achieving glycemic control in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline
- Achieved HbA1c < 7.0% (53 mmol/mol) at Week 72
- Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 72
Measured: 72 weeks
Systolic blood pressure reduction
Change from baseline to Week 72 in systolic blood pressure (mmHg)
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start29 Jun 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Melanie Davies, MBChB, Principal investigator, Diabetes Research Centre Leicester Diabetes Centre - Bloom University of LeicesterDr. Ania Jastreboff, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667803
- Sponsor's protocol ID
- D7260C00015
- Other IDs
- 2025-524688-19, 2025
- Acronym
- Embold
- Status last verified
- Oct 2026
- First submitted
- 19 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.