Clinical trial NCT05872620: A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes
Official title: A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Overweight
Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
* Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:

  * either diet/exercise alone or
  * up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).

Exclusion Criteria:

* Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
* Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laster photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).
* Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.
* Have had a history of chronic or acute pancreatitis.

Primary outcomes:
measure: Mean Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 72
Secondary outcomes:
measure: Mean Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in Hemoglobin A1c (HbA1c) %
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in Fasting Glucose
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in Fasting Triglycerides
timeFrame: Baseline, Week 72
measure: Mean Percent Change from Baseline in Fasting non-High-Density Lipoprotein (HDL) Cholesterol
timeFrame: Baseline, Week 72
measure: Mean Percent Change from Baseline in Fasting Insulin
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in Diastolic Blood Pressure (DBP)
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in Short Form 36 Version 2 Health Survey Acute Form (SF-36v2) Domain Scores
timeFrame: Baseline, Week 72
Other outcomes:
Locations:
city: Pelham
country: United States
facility: Cahaba Research - Pelham
state: Alabama
city: Tucson
country: United States
facility: Novak Clinical Research - Tucson - North La Cholla Boulevard
state: Arizona
city: Yuma
country: United States
facility: Yuma Clinical Trials
state: Arizona
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Westlake
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Margate
country: United States
facility: South Florida Clinical Research Institute
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Lawrenceville
country: United States
facility: Balanced Life Health Care Solutions/SKYCRNG
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Honolulu
country: United States
facility: Pacific Diabetes & Endocrine Center
state: Hawaii
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Baltimore
country: United States
facility: MedStar Good Samaritan Hospital
state: Maryland
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Albuquerque
country: United States
facility: IMA Clinical Research
state: New Mexico
city: Albany
country: United States
facility: Albany Medical College, Division of Community Endocrinology
state: New York
city: Albany
country: United States
facility: Albany Stratton VA Medical Center
state: New York
city: Long Island City
country: United States
facility: NYC Research INC
state: New York
city: Raleigh
country: United States
facility: Accellacare - Raleigh
state: North Carolina
city: Portland
country: United States
facility: Summit Headlands
state: Oregon
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Denison
country: United States
facility: Soma Clinical Trials
state: Texas
city: DeSoto
country: United States
facility: Epic Medical Research - DeSoto
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Center
state: Texas
city: San Antonio
country: United States
facility: VIP Trials
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Tacoma
country: United States
facility: Universal Research Group
state: Washington
city: C.a.b.a.
country: Argentina
facility: CEMEDIAB
state: Ciudad Aut
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación
state: Ciudad Autónoma De Buenos Aires
city: Caba
country: Argentina
facility: Instituto Centenario
state: Ciudad Autónoma De Buenos Aire
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas Rosario
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
state: Santa Fe
city: Venado Tuerto
country: Argentina
facility: Sanatorio San Martin
state: Santa Fe
city: SAN M. DE Tucuman
country: Argentina
facility: Centro de Investigaciones Médicas Tucuman
state: Tucumán
city: Buenos Aires
country: Argentina
facility: CONEXA Investigacion Clinica S.A.
city: Córdoba
country: Argentina
facility: Centro Diabetológico Dr. Waitman
city: Córdoba
country: Argentina
facility: Clínica Universitaria Reina Fabiola
city: Santa Fe
country: Argentina
facility: Centro de Diagnóstico y Rehabilitación (CEDIR)
city: Botany
country: Australia
facility: Emeritus Research
state: New South Wales
city: Merewether
country: Australia
facility: The AIM Centre / Hunter Diabetes Centre
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Core Research Group
state: Queensland
city: Meadowbrook
country: Australia
facility: Logan Hospital
state: Queensland
city: Oaklands Park
country: Australia
facility: Southern Adelaide Diabetes & Endocrine Services
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Heidelberg West
country: Australia
facility: Austin Health - Repatriation Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Baker IDI Heart and Diabetes Institute - Melbourne
state: Victoria
city: Joondalup
country: Australia
facility: Advara HeartCare Joondalup
state: Western Australia
city: Brasilia
country: Brazil
facility: Centro de Pesquisa Clinica do Brasil
state: Distrito Federal
city: Goiânia
country: Brazil
facility: Cendi - Endocrinologia e Diabetes
state: Goiás
city: Volta Redonda
country: Brazil
facility: Instituto Lóbus
state: Rio De Janeiro
city: Passo Fundo
country: Brazil
facility: Instituto Méderi de Pesquisa e Saúde
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Instituto de Pesquisa clinica de Campinas
state: São Paulo
city: Marília
country: Brazil
facility: Centro de Pesquisa Clínica de Marília - CPCLIM
state: São Paulo
city: Santo André
country: Brazil
facility: Pesquisare Saude
state: São Paulo
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
state: Anhui
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Chongqing
city: Shenzhen
country: China
facility: ShenZhen People's Hospital
state: Guangdong
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Luoyang Shi
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Official Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nantong
country: China
facility: Nantong First People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Dalian
country: China
facility: Dalian Municipal Central Hospital Affiliated of Dalian Medical University
state: Liaoning
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Zhu Xianyi Memorial Hospital
state: Tianjin
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Ceske Budejovice
country: Czechia
facility: MUDr. Alena Vachova
state: Jihočeský
city: Krnov
country: Czechia
facility: MUDr. Tomas Edelsberger
state: Moravskosl
city: Pardubice V
country: Czechia
facility: Diahelp s.r.o
state: Pardubice
city: Pilsen
country: Czechia
facility: Dialine - Interni a diabetologicka ambulance
state: Plzeň-město
city: Praha
country: Czechia
facility: Diabet2 s.r.o., diabetologicka a interni ambulance
state: Praha 1
city: Praha
country: Czechia
facility: Milan Kvapil s.r.o., Diabetologicka ambulance
state: Praha 4
city: Praha
country: Czechia
facility: ResTrial s.r.o.
state: Praha 8
city: Jilove u Prahy
country: Czechia
facility: MUDr. Sabina Palova
state: Praha-západ
city: Pribram
country: Czechia
facility: Milan Kvapil s.r.o., Diabetologicka ambulance Pribram
state: Středočeský Kraj
city: Hradec Kralove
country: Czechia
facility: Endokrinologie MUDr. Rehorkova s.r.o.
city: Plzen
country: Czechia
facility: MUDr. Jitka Zemanová - diabetologie a interna s.r.o.
city: Český Krumlov
country: Czechia
facility: Nemocnice Cesky Krumlov
city: München
country: Germany
facility: CDG Studienambulanz Hartard
state: Bayern
city: Wallerfing
country: Germany
facility: Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf
state: Bayern
city: Pohlheim
country: Germany
facility: Ceda-Research
state: Hessen
city: Essen
country: Germany
facility: InnoDiab Forschung Gmbh
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Medizentrum Essen Borbeck
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster
state: Nordrhein-
city: Hohenmölsen
country: Germany
facility: Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: SMO.MD GmbH
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: AmBeNet GmbH
state: Sachsen
city: Pirna
country: Germany
facility: Arztpraxis Christine Kosch Pirna
state: Sachsen
city: Lübeck
country: Germany
facility: Universität zu Lübeck - Institut für Endokrinologie und Diabetes
state: Schleswig-Holstein
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Gelnhausen
country: Germany
facility: Diabetes Zentrum Dr. Tews
city: Hamburg
country: Germany
facility: Diabetes Zentrum Wilhelmsburg
city: Athens
country: Greece
facility: Athens Medical Center
state: Attikí
city: Thessaloniki
country: Greece
facility: Ippokrateio General Hospital of Thessaloniki
state: Kentrikí Makedonía
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki
state: Thessaloníki
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital of Thessaloniki
state: Thessaloníki
city: Thessaloniki
country: Greece
facility: Thermi Clinic
state: Thessaloníki
city: Larissa
country: Greece
facility: University General Hospital of Larissa
state: Thessalía
city: Thessaloniki
country: Greece
facility: 424 Military General Training Hospital
city: Bangalore
country: India
facility: Medstar Speciality Hospital
state: Karnataka
city: Hubli
country: India
facility: Karnataka Institute of Medical Sciences
state: Karnataka
city: Indore
country: India
facility: TOTALL Diabetes Hormone Institute
state: Madhya Pradesh
city: Mumbai
country: India
facility: Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
state: Maharashtra
city: Mumbai
country: India
facility: BSES MG Hospital
state: Maharashtra
city: Nagpur
country: India
facility: All India Institute of Medical Sciences (AIIMS) - Nagpur
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Super Speciality Hospital
state: Maharashtra
city: Madurai
country: India
facility: Arthur Asirvatham Hospital
state: Tamil Nadu
city: Hyderabad
country: India
facility: Kumudini Devi Diabetes Research Center
state: Telangana
city: Wonju
country: Korea, Republic of
facility: Yonsei University-Wonju Severance Christian Hospital
state: Kang-won-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Gyeongsan-si
country: Korea, Republic of
facility: Yeungnam Univeristy Medical Center
state: Kyǒngsangbuk-do
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
state: Seoul-teukbyeolsi [Seoul]
city: Bayamón
country: Puerto Rico
facility: Advanced Clinical Research, LLC
city: Guaynabo
country: Puerto Rico
facility: Isis Clinical Research Center
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: