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A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM
Sponsor: AstraZeneca
Summary
This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
4500
Start Date
2026-06-29
Completion Date
2029-07-30
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Elecoglipron
Elecoglipron film-coated tablet once daily
Placebo
Placebo matching elecoglipron film-coated tablet once daily
Locations (325)
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Chandler, Arizona, United States
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Sun City, Arizona, United States
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Little Rock, Arkansas, United States
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Lynwood, California, United States
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Rolling Hills Estates, California, United States
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Sacramento, California, United States
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Arvada, Colorado, United States
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New Haven, Connecticut, United States
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Plantation, Florida, United States
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Tampa, Florida, United States
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Woodstock, Georgia, United States
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Ammon, Idaho, United States
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Melrose Park, Illinois, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Alexandria, Louisiana, United States
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Baltimore, Maryland, United States
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Potomac, Maryland, United States
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White Marsh, Maryland, United States
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Ypsilanti, Michigan, United States
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Ridgeland, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Reno, Nevada, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Laurelton, New York, United States
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Long Island City, New York, United States
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Greensboro, North Carolina, United States
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Raleigh, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Statesville, North Carolina, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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DuBois, Pennsylvania, United States
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Newport, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Gaffney, South Carolina, United States
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Rapid City, South Dakota, United States
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Franklin, Tennessee, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Humble, Texas, United States
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Irving, Texas, United States
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Sandy City, Utah, United States
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Midlothian, Virginia, United States
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Morgantown, West Virginia, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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CABA, Argentina
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CABA, Argentina
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Caba, Argentina
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Capital Federal, Argentina
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Granadero Baigorria, Argentina
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Lanus, Argentina
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Rosario, Argentina
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Rosario, Argentina
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San Nicolás, Argentina
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San Vicente, Argentina
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Botany, Australia
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Camberwell, Australia
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Charlestown, Australia
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Maroubra, Australia
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St Albans, Australia
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St Leonards, Australia
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Belém, Brazil
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Brasília, Brazil
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Campinas, Brazil
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Campinas, Brazil
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Curitiba, Brazil
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Fortaleza, Brazil
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Porto Alegre, Brazil
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São José dos Campos, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Calgary, Alberta, Canada
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Truro, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Hamilton, Ontario, Canada
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Niagara Falls, Ontario, Canada
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North York, Ontario, Canada
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Sarnia, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Stouffville, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada