Clinical trial NCT05869903: A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
Official title: A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Overweight
Overweight or Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-05-22
Enrollment: 3000
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 efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities.


Eligibility criteria: Inclusion Criteria:

* Have a BMI

  * ≥30.0 kilogram/square meter (kg/m²),
  * ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:

    * Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria:

* Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
* Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
* Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 syndrome.
* Have had a history of chronic or acute pancreatitis.

Primary outcomes:
measure: Mean Percent Change from Baseline in Body Weight
timeFrame: Baseline to Week 72
Secondary outcomes:
measure: Mean Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 72
measure: Mean Percent Change from Baseline in Fasting non-HDL Cholesterol
timeFrame: Baseline, Week 72
measure: Mean Percent Change from Baseline in Fasting Triglycerides
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 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 Version 2 (SF-36v2) Acute Form Domain Scores
timeFrame: Baseline, Week 72
Other outcomes:
Locations:
city: Chandler
country: United States
facility: The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
state: Arizona
city: Sun City West
country: United States
facility: Clinical Research Institute of Arizona (CRI) - Sun City West
state: Arizona
city: Concord
country: United States
facility: John Muir Physician Network Research Center
state: California
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Greenbrae
country: United States
facility: NorCal Medical Research, Inc
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: San Ramon
country: United States
facility: Norcal Endocrinology & Internal Medicine
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Miami
country: United States
facility: New Age Medical Research Corporation
state: Florida
city: Miramar
country: United States
facility: South Broward Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Tampa
country: United States
facility: Jedidiah Clinical Research - Tampa - Bay Plaza
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC dba Flourish Research
state: Florida
city: Lawrenceville
country: United States
facility: Physicians Research Associates
state: Georgia
city: Macon
country: United States
facility: East Coast Institute for Research, LLC
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes & Endocrinology
state: Kansas
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Lake Charles
country: United States
facility: Care Access - Lake Charles
state: Louisiana
city: Hyattsville
country: United States
facility: MedStar Health Research Institute (MedStar Physician Based Research Network)
state: Maryland
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG
state: Mississippi
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Lake Success
country: United States
facility: Long Island Cardiovascular Consultants
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Oklahoma
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Dallas
country: United States
facility: Thyroid, Endocrinology, and Diabetes
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Wylie
country: United States
facility: Soma Clinical Trials
state: Texas
city: Draper
country: United States
facility: Physicians' Research Options
state: Utah
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
city: Fortaleza
country: Brazil
facility: Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas
state: Ceará
city: Vitória
country: Brazil
facility: CEDOES
state: Espírito Santo
city: Bequimao
country: Brazil
facility: Hospital São Domingos
state: Maranhão
city: Curitiba
country: Brazil
facility: Cline Research Center
state: Paraná
city: Curitiba
country: Brazil
facility: Quanta Diagnóstico e Terapia
state: Paraná
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Centro de Pesquisa Sao Lucas
state: São Paulo
city: Jaú
country: Brazil
facility: CECIP - Centro de Estudos do Interior Paulista
state: São Paulo
city: Sao Bernardo do Campo
country: Brazil
facility: Centro Multidisciplinar de Estudos Clinicos
state: São Paulo
city: Votuporanga
country: Brazil
facility: Integral Pesquisa e Ensino
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital São Lucas de Copacabana
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: São Paulo
country: Brazil
facility: Hospital das Clinicas FMUSP
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: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
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: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Jiading District Central Hospital
state: Shanghai
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: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Guntur
country: India
facility: Endolife Speciality Hospitals
state: Andhra Pradesh
city: Bangalore
country: India
facility: Victoria Hospital, Bangalore Medical College And Research Institute
state: Karnataka
city: Mysore
country: India
facility: Mysore Medical College
state: Karnataka
city: Nagpur
country: India
facility: Central India Cardiology and Research Institute
state: Maharashtra
city: Nagpur
country: India
facility: All India Institute of Medical Sciences (AIIMS) - Nagpur
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Centre
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Super Speciality Hospital
state: Maharashtra
city: Pune
country: India
facility: Lifepoint Multispeciality Hospital
state: Maharashtra
city: Kasuya
country: Japan
facility: Oishi Clinic
state: Fukuoka
city: Aki-gun
country: Japan
facility: Mazda Hospital
state: Hiroshima
city: Tsuchiura
country: Japan
facility: Tsuchiura Medical & Health Care Center
state: Ibaraki
city: Takamatsu
country: Japan
facility: NTT Nishinihon Takamatsu Clinic
state: Kagawa
city: Zentsuji
country: Japan
facility: Iwamoto Internal Medicine Clinic
state: Kagawa
city: Yokohama
country: Japan
facility: Yokohama Minoru Clinic
state: Kanagawa
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Soka
country: Japan
facility: Sugiura Internal Medicine Clinic
state: Saitama
city: Adachi-ku
country: Japan
facility: Adachi Kyosai Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: Medical Corporation Chiseikai Tokyo Center Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Meguro-ku
country: Japan
facility: Yutenji Medical Clinic
state: Tokyo
city: Mitaka
country: Japan
facility: Kanno Naika
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Shimokitazawa Tomo Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Heishinkai Medical Group ToCROM Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Boocs Clinic Fukuoka
city: Osaka
country: Japan
facility: Osaka Nishiumeda Clinic
city: Namdong-gu
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Incheon-gw
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Kyǒnggi-do
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Kyǒnggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Kyǒnggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Kyǒngsangnam-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seo-gu
country: Korea, Republic of
facility: Konyang University Hospital
state: Taejǒn-Kwangyǒkshi
city: Dorado
country: Puerto Rico
facility: Dorado Medical Complex
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
city: Lucenec
country: Slovakia
facility: Nemocnica s poliklinikou Lucenec
state: Banskobystrický Kraj
city: Bratislava
country: Slovakia
facility: Metabol KLINIK
state: Bratislavský Kraj
city: Kosice
country: Slovakia
facility: Human Care s.r.o.
state: Košický Kraj
city: Trebisov
country: Slovakia
facility: Areteus s.r.o.
state: Košický Kraj
city: Roznava
country: Slovakia
facility: DIAB sro
state: Košický Kr
city: Sabinov
country: Slovakia
facility: MEDI-DIA s.r.o.
state: Prešovský Kraj
city: Puchov
country: Slovakia
facility: DIA-MED CENTRUM s.r.o.
state: Trenčiansky Kraj
city: Bratislava
country: Slovakia
facility: MediTask
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña
state: A Coruña [La Coruña]
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
state: A Coruña [La Coruña]
city: Almeria
country: Spain
facility: Centro Periférico de Especialidades Bola Azul
state: Almería
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Quiron Infanta Luisa
state: Andalucía
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Centro Médico Teknon
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
state: Castilla Y León
city: Sanlúcar de Barrameda
country: Spain
facility: Hospital Virgen del Camino
state: Cádiz
city: Villamartin
country: Spain
facility: Hospital Virgen de las Montañas
state: Cádiz
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
state: Valenciana, Comunitat
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Chiayi City
country: Taiwan
facility: Chiayi Christian Hospital
state: Chiayi
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
state: Kaohsiung
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
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: