Type 2 Diabetes (T2D) Clinical Trials

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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)

Status: Recruiting
Location: See all (321) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
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Birmingham
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Dothan
Arkansas
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Little Rock
Arizona
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Chandler
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Peoria
California
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Lynwood
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Rolling Hills Estates
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Sacramento
Colorado
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Arvada
Connecticut
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New Haven
Florida
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Clearwater
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Plantation
Georgia
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Woodstock
Idaho
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Ammon
Illinois
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Melrose Park
Indiana
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Indianapolis
Kansas
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Wichita
Kentucky
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Louisville
Louisiana
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Alexandria
Maryland
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Baltimore
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Potomac
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White Marsh
Michigan
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Ypsilanti
Missouri
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Kansas City
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St Louis
Mississippi
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Ridgeland
North Carolina
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Greensboro
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Raleigh
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Rocky Mount
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Statesville
New Mexico
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Albuquerque
Nevada
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Reno
New York
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Albany
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Laurelton
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Long Island City
Ohio
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Columbus
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Dayton
Oklahoma
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Edmond
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Tulsa
Oregon
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Portland
Pennsylvania
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Dubois
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Newport
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Philadelphia
Rhode Island
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East Providence
South Carolina
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Charleston
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Gaffney
South Dakota
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Rapid City
Tennessee
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Franklin
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Knoxville
Texas
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Dallas
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Houston
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Humble
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Irving
Utah
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Sandy City
Virginia
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Midlothian
West Virginia
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Morgantown
Other Locations
Argentina
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Buenos Aires
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Buenos Aires
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Caba
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Caba
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Caba
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Capital Federal
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Granadero Baigorria
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Lanus
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Rosario
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Rosario
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San Nicolás
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San Vicente
Australia
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Botany
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Camberwell
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Kotara
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Maroubra
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St Albans
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St Leonards
Brazil
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Belém
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Brasília
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Campinas
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Campinas
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Curitiba
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Fortaleza
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Porto Alegre
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São José Dos Campos
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São Paulo
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São Paulo
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São Paulo
Canada
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Brampton
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Calgary
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Calgary
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Hamilton
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Joliette
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Moncton
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Montreal
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Niagara Falls
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North York
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Saint-lambert
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Sarnia
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Scarborough Village
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Stouffville
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Terrebonne
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Toronto
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Toronto
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Toronto
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Truro
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Vancouver
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Victoria
Chile
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Araucania
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Concepción
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Las Condes
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Osorno
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Providencia
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Santiago
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Santiago
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Santiago
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Santiago
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Temuco
China
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Binzhou
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Chengdu
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Chengdu
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Deyang
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Ganzhou
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Guangzhou
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Guangzhou
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Haikou
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Hangzhou
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Hangzhou
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Huaian
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Huzhou
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Jinan
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Jinzhou
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Kunming
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Lanzhou
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Linhai
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Liuzhou
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Luoyang
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Nanchang
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Nanjing
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Nanjing
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Nantong
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Ningbo
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Panjin
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Pingxiang
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Qingdao
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Shanghai
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Shanghai
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Shenyang
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Shenzhen
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Siping
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Suining
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Suzhou
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Ürümqi
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Wanzhou
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Wenzhou
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Wuhan
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Wuxi
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Xiangfan
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Xuancheng
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Yibin
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Yichang
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Zhengzhou
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Zhenjiang
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Zunyi
Germany
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Bad Oeynhausen
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Bochum
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Cologne
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Cologne
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Dresden
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Falkensee
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Gera
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Hamburg
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Leipzig
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Leipzig
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Lübeck
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Mainz
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Mannheim
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München
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Münster
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Nuremberg
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Obertshausen
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Oldenburg
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Stuttgart
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Ulm
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Wangen
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Würzburg
India
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Bangalore
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Belagavi
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Bikaner
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Delhi
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Guntur
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Hyderabad
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Jodhpur
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Kolkata
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Kolkata
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Madurai
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Mumbai
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Mumbai
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Mysore
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Nagpur
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New Delhi
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SUSPENDED
Siliguri
Italy
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Bologna
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Catania
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Chieti
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Florence
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Latina
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Milan
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Pisa
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Ravenna
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Roma
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Roma
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San Donato
Japan
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Amagasaki-shi
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Chūōku
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Chūōku
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Kasugai-shi
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Koga-shi
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Maebashi
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Minatoku
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Minatoku
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Naka
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Shinjuku-ku
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Shizuoka
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Suita-shi
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Suita-shi
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Toshima-ku
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Yamato-shi
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Yokohama
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Yokohama
Poland
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Bialystok
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Bialystok
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Bydgoszcz
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Kielce
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Krakow
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Krakow
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Krakow
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Lodz
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Lublin
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Lublin
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Poznan
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Poznan
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Radom
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Warsaw
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Warsaw
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Warsaw
Republic of Korea
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Busan
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Busan
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Daegu
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Goyang-si
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Gyeonggi-do
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Incheon
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Jongno-gu
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Seoul
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Seoul
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Suwon
Saudi Arabia
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Al-ahsa
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Dammam
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Jeddah
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Khobar
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Riyadh
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Riyadh
South Africa
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Bellville
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Bloemfontein
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Cape Town
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Cape Town
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Chatsworth
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Claremont
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Durban
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Emkhomazi
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Johannesburg
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Johannesburg
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Midrand
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Wentworth
Spain
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A Coruña
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Almería
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Badalona
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Barcelona
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Barcelona
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Barcelona
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León
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Madrid
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Santander
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Santiago De Compostela
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Seville
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Seville
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Seville
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Tarragona
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Valencia
Taiwan
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Changhua
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Kaohsiung City
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RECRUITING
Taichung
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Taichung
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Taichung
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Taichung
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Tainan
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Tainan County
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Taipei
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Taipei
Turkey
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Adana
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Adana
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Adapazarı
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Ankara
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Ankara
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Ankara
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Antalya
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Istanbul
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Istanbul
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Istanbul
United Kingdom
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Ashton-under-lyne
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Blackpool
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Chesterfield
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Corby
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Ely
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Glasgow
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Hounslow
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Leicester
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Metropolitan Borough Of Wirral
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Poole
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Rotherham
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WITHDRAWN
Stowmarket
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WITHDRAWN
Wansford
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NOT_YET_RECRUITING
Witney
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NOT_YET_RECRUITING
Yate
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2026-06-29
Estimated Completion Date: 2029-07-30
Participants
Target number of participants: 4500
Treatments
Experimental: Arm 1 - Dose 1
Active IMP
Experimental: Arm 2 - Dose 2
Active IMP
Placebo_comparator: Arm 3 - Placebo
Placebo matching elecoglipron
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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