A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
ATTAIN-NOW
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Individuals With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
3 other identifiers
interventional
2,001
12 countries
180
Brief Summary
This study will evaluate the efficacy and safety of orforglipron in participants with overweight and assess whether it helps reduce the future risk of obesity-related conditions, including type 2 diabetes, hypertension, and dyslipidemia, and progression to class 1 obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2026
Typical duration for phase_3
180 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2026
CompletedStudy Start
First participant enrolled
August 26, 2026
CompletedFirst Posted
Study publicly available on registry
August 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
September 28, 2026
September 1, 2026
2.9 years
August 26, 2026
September 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Onset of Obesity Related Complications or Class 1 Obesity
Obesity related complications defined as type 2 diabetes, hypertension, or dyslipidemia; Class 1 obesity defined as body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or an equivalent region-specific threshold
Baseline to Week 104
Secondary Outcomes (12)
Percent Change from Baseline in Body Weight
Baseline, Week 104
Time to Onset of Waist-to-Height Ratio ≥0.6
Baseline to Week 104
Change from Baseline in Waist Circumference
Baseline, Week 104
Time to Onset of Class 1 Obesity
Baseline to Week 104
Time to First Occurrence of Composite Endpoint of Type 2 Diabetes, Hypertension, Dyslipidemia
Baseline to Week 104
- +7 more secondary outcomes
Study Arms (3)
Orforglipron
EXPERIMENTALParticipants will receive orforglipron orally
Orforglipron to Placebo
EXPERIMENTALParticipants will receive orforglipron orally followed by placebo orally
Placebo to Orforglipron
EXPERIMENTALParticipants will receive placebo orally followed by orforglipron orally
Interventions
Administered orally
Eligibility Criteria
You may qualify if:
- Have an increased waist-to-height ratio of ≥0.5
- Have at least one pre-obesity-related complication (prediabetes, prehypertension, predyslipidemia)
- Have at least one unsuccessful attempt to reduce body weight based on diet and exercise
- Have a BMI greater than or equal to 25 to less than or equal to 29.9 kg/m2 or equivalent-/region-specific overweight thresholds
You may not qualify if:
- Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- Do not have a stable body weight within 90 days before screening
- Have a documented obesity diagnosis or self-reported history of BMI ≥30 kg/m² (or an equivalent region-specific threshold)
- Have taken medications for weight loss, including over-the counter medications or alternative therapies, within 180 days prior to screening
- Have a prior or planned surgical treatment or procedure for obesity
- Have hypertension or history of hypertension
- Have dyslipidemia or history of dyslipidemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (180)
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
Central Research Associates
Birmingham, Alabama, 35205, United States
Cahaba Research - Pelham
Pelham, Alabama, 35124, United States
Care Access - 801 South Power Road, Mesa
Mesa, Arizona, 85206, United States
Absolute Clinical Research
Phoenix, Arizona, 85051, United States
Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson, Arizona, 85741, United States
Orange County Research Center
Lake Forest, California, 92630, United States
Healthy Brain Clinic
Long Beach, California, 90804, United States
Los Angeles Institute for Metabolic Research
Los Angeles, California, 90015, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Riverside Clinical
Riverside, California, 92506, United States
Headlands Research- Sacramento
Sacramento, California, 95821, United States
Norcal Endocrinology & Internal Medicine
San Ramon, California, 94583, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Yale University School of Medicine
New Haven, Connecticut, 06519, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434, United States
Flourish Research Acquisition, LLC dba Flourish Research - North Miami
Miami, Florida, 33138, United States
New Age Medical Research Corporation
Miami, Florida, 33186, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Headlands Research Orlando
Orlando, Florida, 32803, United States
Oviedo Medical Research
Oviedo, Florida, 32765, United States
Care Access - St. Petersburg
St. Petersburg, Florida, 33710, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
SKY Clinical Research Network Group-Brown
Atlanta, Georgia, 30331, United States
HOPE Clinical Research & Wellness
Conyers, Georgia, 30094, United States
Care Access - Dalton Walmart
Dalton, Georgia, 30720, United States
Care Access - Decatur
Decatur, Georgia, 30030, United States
Family First Medical Center
Idaho Falls, Idaho, 83404, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
Monroe Biomedical Research - Louisville
Louisville, Kentucky, 40213, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
IMA Clinical Research Monroe-Main
Monroe, Louisiana, 71201, United States
Centennial Medical Group
Columbia, Maryland, 21045, United States
Brigham and Women's Hospital Diabetes Program
Boston, Massachusetts, 02115, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
Great Lakes Research Institute
Southfield, Michigan, 48075, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
Headlands Research-Twin Cities
Maplewood, Minnesota, 55109, United States
Clinvest Headlands Llc
Springfield, Missouri, 65807, United States
M3 Wake Research - Las Vegas Cimarron
Las Vegas, Nevada, 89113, United States
Renascor Clinical Research
Reno, Nevada, 89509, United States
IMA Clinical Research Warren
Warren Township, New Jersey, 07059, United States
Drug Trials America
Hartsdale, New York, 10530, United States
NYC Research INC
Long Island City, New York, 11106, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Medication Management
Greensboro, North Carolina, 27401, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
West Clinical Research
Morehead City, North Carolina, 28557, United States
Trial Management Associates - Wilmington - Floral Parkway
Wilmington, North Carolina, 28403, United States
Lillestol Research
Fargo, North Dakota, 58104, United States
Remington-Davis, Inc
Columbus, Ohio, 43215, United States
Central States Research
Tulsa, Oklahoma, 74136, United States
The Corvallis Clinic, P.C.
Corvallis, Oregon, 97330, United States
Clinical Renal Associates Ltd.
Media, Pennsylvania, 19063, United States
Suburban Research Associates
West Chester, Pennsylvania, 19380, United States
Care Access - Mauldin
Mauldin, South Carolina, 29662, United States
New Phase Research and Development
Knoxville, Tennessee, 37909, United States
Clinical Research Associates Inc
Nashville, Tennessee, 37203, United States
IMA Clinical Research Austin
Austin, Texas, 78745, United States
Headlands Horizons, LLC dba Headlands Research-Brownsville
Brownsville, Texas, 78526, United States
Cedar Health Research - Texas Native Health
Dallas, Texas, 75235, United States
Headlands Research-El Paso
El Paso, Texas, 79902, United States
Cedar Health Research - Euless
Euless, Texas, 76040, United States
Biopharma Informatic, LLC
Houston, Texas, 77043, United States
Care Access - Houston - Clinical Trials Center by Walmart & Care Access
Houston, Texas, 77082, United States
Activian Clinical Research
Kingwood, Texas, 77339, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229, United States
VIP Trials
San Antonio, TX 78230, Texas, 78230, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Care Access - Tyler - Clinical Trials Center by Walmart & Care Access
Tyler, Texas, 75704, United States
Sovah Clinical Research-River District
Danville, Virginia, 24541, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23226, United States
CAMC Institute for Academic Medicine
Charleston, West Virginia, 25304, United States
Frontier Clinical Research, LLC
Kingwood, West Virginia, 26537, United States
CONEXA Investigacion Clinica S.A.
Buenos Aires, 1012, Argentina
CIPREC
Buenos Aires, 1061, Argentina
CARDIAMET Investigaciones Médicas
Buenos Aires, C1014ACP, Argentina
Investigaciones Medicas Imoba Srl
Buenos Aires, C1056ABH, Argentina
Centro Médico Viamonte
Buenos Aires, C1120AAC, Argentina
CEMEDIC
Buenos Aires, C1407GTN, Argentina
Fundación Respirar
Buenos Aires, C1426ABP, Argentina
Instituto Centenario
CABA, 1204, Argentina
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires, C1012AAR, Argentina
Sanatorio Esperanza
Esperanza, 3080, Argentina
Centro Diagnóstico Bioimagenes
Lanus, 1824, Argentina
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, 7600, Argentina
Instituto de Cardiología Wolff
Mendoza, 5500, Argentina
Instituto Especialidades de la Salud Rosario
Rosario, 2000, Argentina
Instituto de Investigaciones Clinicas Rosario
Rosario, S2000CVD, Argentina
CardioAlem Investigaciones
San Isidro, 1642, Argentina
Instituto Médico de Alta Complejidad San Isidro Sa
San Isidro, 1642, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, T4000AXL, Argentina
Instituto de Investigaciones Clínicas San Nicolas
San Nicolás de los Arroyos, 2900, Argentina
Centro de Investigaciones Clinicas del Litoral
Santa Fe, S3000FWO, Argentina
Sichuan Provincial People's Hospital
Chengdu, 610072, China
The Second People's Hospital of Hefei
Hefei, 230011, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022, China
Jinan Central Hospital
Jinan, 250013, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, 471003, China
Nanjing First Hospital
Nanjing, 210006, China
Jiangsu Province Official Hospital
Nanjing, 210008, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011, China
Ningbo First Hospital
Ningbo, 315010, China
The First Hospital of Qinhuangdao
Qinhuangdao Shi, 066000, China
Tianjin Medical University Zhu Xianyi Memorial Hospital
Tianjin, China
EFERTUS healthcare s.r.o.
Brno, 615 00, Czechia
MUDr. Alena Vachova
České Budějovice, 37011, Czechia
Habrypraktik s.r.o.
Habry, 582 81, Czechia
CCR Ostrava s.r.o
Ostrava, 702 00, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulance
Prague, 14900, Czechia
MUDr. Barbora Diepoltova
Praha 9 - Klanovice, 190 14, Czechia
Medical Plus Research
Uherské Hradiště, 686 01, Czechia
FutureMeds Berlin
Berlin, 10629, Germany
Siteworks GmbH - Bochum
Bochum, 44787, Germany
Siteworks GmbH - Hannover
Hanover, 30449, Germany
Dr. MILEK-medikum
Hohenmölsen, 06679, Germany
Siteworks - Karlsruhe
Karlsruhe, 76137, Germany
AmBeNet GmbH
Leipzig, 04107, Germany
Rahman & Detho Studien GmbH
Obertshausen, 63179, Germany
FutureMeds Offenbach
Offenbach, 63065, Germany
RED-Institut GmbH
Oldenburg, 23758, Germany
Sanos Clinic
Ratingen, 40882, Germany
Jawaharlal Nehru Medical College
Aligarh, 202002, India
GMERS Medical College and General Hospital
Baroda, 390021, India
Endolife Speciality Hospitals
Guntur, 522001, India
Karnataka Institute of Medical Sciences
Hubli, 580021, India
Eternal Heart Care Center and Research Institute
Jaipur, 302020, India
Mysore Medical College
Mysore, 570001, India
Datta Meghe Institute of Medical Sciences (DMIMS) - Shalinitai Meghe Hospital and Research Center
Nagpur, 441110, India
Jothydev's Diabetes and Research Center
Trivandrum, 695032, India
Christian Medical College Vellore
Vellore, 632004, India
Nihonbashi Sakura Clinic
Chūōku, 103-0025, Japan
Tokyo Asbo Clinic
Chūōku, 104-0031, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, 565-0853, Japan
Tsuchiura Medical & Health Care Center
Tsuchiura, 300-0012, Japan
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
Ciudad Madero, 89440, Mexico
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
Culiacán, 80230, Mexico
Diseno y Planeacion en Investigacion Medica - Guadalajara - Calle Amado Nervo
Guadalajara, 44600, Mexico
Gastrobariátrica Santa Fe
Mexico City, 05348, Mexico
Kohler & Milstein Research S.A. De C.V.
Mérida, 97070, Mexico
Medical Care and Research SA de CV
Mérida, 97070, Mexico
Centro de investigación y control metabólico
Monterrey, 66465, Mexico
Servicios Integrales Nova de Monterrey S.A. de C.V.
San Nicolás de los Garza, 66450, Mexico
Medimanage Research
Tlalpan, 14050, Mexico
Ponce Medical School Foundation Inc.
Ponce, 00716, Puerto Rico
Latin Clinical Trial Center
San Juan, 00909, Puerto Rico
Mgcendo Llc
San Juan, 00921, Puerto Rico
Korea University Ansan Hospital
Ansan-si, 15355, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, 14068, South Korea
Pusan National University Yangsan Hospital
Busan, 50612, South Korea
Hanyang University Guri Hospital
Guri-si, 11923, South Korea
Chosun University Hospital
Gwangju, 61453, South Korea
Kyungpook National University Hospital
Junggu, 41944, South Korea
Konyang University Hospital
Seogu, 35365, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, 13496, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
Accellacare España
Alcobendas, 28100, Spain
EAP Sardenya
Barcelona, 08025, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
EAP Osona Sud - Alt Congost S.L.P
Centelles, 08540, Spain
C.R.A. Investigación Clínica
Ferrol, 15402, Spain
Hospital Vithas La Salud
Granada, 18008, Spain
FutureMeds - Madrid
Madrid, 28003, Spain
Centro de Salud San Juan de la Cruz
Pozuelo de Alarcón, 28224, Spain
Vithas Hospital Sevilla
Seville, 41950, Spain
Hospital Ascires
Valencia, 46014, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
China Medical University Hospital
Taichung, 404332, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Cathay General Hospital
Taipei, 106, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2026
First Posted
August 31, 2026
Study Start
August 26, 2026
Primary Completion (Estimated)
August 1, 2029
Study Completion (Estimated)
September 1, 2030
Last Updated
September 28, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.