ObesityPhase 3ATTAIN-2NCT05872620
A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes
A Phase 3 study testing Orforglipron in people with Obesity and Overweight, run by Eli Lilly and Company at 136 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight, Type 2 Diabetes
- What is being tested?
- Orforglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,613 participants
- Where
- 136 sitesin 11 countries
- Study dates
- 5 Jun 2023to 8 Aug 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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, laser 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.
Trial locations and contacts
136 sites in 11 countries.
136 sites in 11 countries
United States37 sites
Albany Medical College, Division of Community Endocrinology
Albany, New York, 12203
Albany Stratton VA Medical Center
Albany, New York, 12208
IMA Clinical Research
Albuquerque, New Mexico, 87109
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21239
Charlottesville Medical Research
Charlottesville, Virginia, 22911
StudyMetrix Research
City of Saint Peters, Missouri, 63303
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
Soma Clinical Trials
Denison, Texas, 75020
Epic Medical Research - DeSoto
DeSoto, Texas, 75115
AMCR Institute
Escondido, California, 92025
Encore Medical Research
Hollywood, Florida, 33024
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96813
Biopharma Informatic, LLC
Houston, Texas, 77043
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909
Las Vegas Medical Research
Las Vegas, Nevada, 89128
Balanced Life Health Care Solutions/SKYCRNG
Lawrenceville, Georgia, 30046
NYC Research INC
Long Island City, New York, 11106
Velocity Clinical Research, Westlake
Los Angeles, California, 90057
South Florida Clinical Research Institute
Margate, Florida, 33063
Solaris Clinical Research
Meridian, Idaho, 83646
Catalina Research Institute, LLC
Montclair, California, 91763
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Cahaba Research - Pelham
Pelham, Alabama, 35124
Summit Headlands
Portland, Oregon, 97210
Accellacare - Raleigh
Raleigh, North Carolina, 27609
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076
Diabetes and Glandular Disease Center
San Antonio, Texas, 78229
VIP Trials
San Antonio, Texas, 78230
Universal Research Group
Tacoma, Washington, 98405
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
Novak Clinical Research - Tucson - North La Cholla Boulevard
Tucson, Arizona, 85741
University Clinical Investigators, Inc.
Tustin, California, 92780
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265
North Georgia Clinical Research
Woodstock, Georgia, 30189
Yuma Clinical Trials
Yuma, Arizona, 85364
China18 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Chongqing General Hospital
Chongqing, Chongqing Municipality, 400014
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, 116033
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
The Second People's Hospital of Hefei
Hefei, Anhui, 230011
Jinan Central Hospital
Jinan, Shandong, 250013
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650034
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, 471003
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Jiangsu Province Official Hospital
Nanjing, Jiangsu, 210008
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Nantong First People's Hospital
Nantong, Jiangsu, 226001
ShenZhen People's Hospital
Shenzhen, Guangdong, 518020
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Tianjin Medical University Zhu Xianyi Memorial Hospital
Tianjin, Tianjin Municipality
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014
Germany15 sites
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, 50937
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, 45136
Medizentrum Essen Borbeck
Essen, North Rhine-Westphalia, 45355
Diabetes Zentrum Dr. Tews
Gelnhausen, 63571
Diabetes Zentrum Wilhelmsburg
Hamburg, 21109
Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels
Hohenmölsen, Saxony-Anhalt, 06679
AmBeNet GmbH
Leipzig, Saxony, 04107
Universität zu Lübeck - Institut für Endokrinologie und Diabetes
Lübeck, Schleswig-Holstein, 23562
SMO.MD GmbH
Magdeburg, Saxony-Anhalt, 39120
CDG Studienambulanz Hartard
München, Bavaria, 80809
Institut für Diabetesforschung GmbH Münster
Münster, Nordrhein-, 48145
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758
Arztpraxis Christine Kosch Pirna
Pirna, Saxony, 01796
Ceda-Research
Pohlheim, Hesse, 35415
Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf
Wallerfing, Bavaria, 94574
Czechia12 sites
MUDr. Alena Vachova
České Budějovice, South Bohemian Region, 37011
Nemocnice Cesky Krumlov
Český Krumlov, 381 01
Endokrinologie MUDr. Rehorkova s.r.o.
Hradec Králové, 500 12
MUDr. Sabina Palova
Jílové u Prahy, Praha-západ, 252 42
MUDr. Tomas Edelsberger
Krnov, Moravskosl, 79401
Diahelp s.r.o
Pardubice V, Pardubice, 530 02
Dialine - Interni a diabetologicka ambulance
Pilsen, Plzeň-město, 301 00
MUDr. Jitka Zemanová - diabetologie a interna s.r.o.
Pilsen, 326 00
Diabet2 s.r.o., diabetologicka a interni ambulance
Prague, Praha 1, 11000
Milan Kvapil s.r.o., Diabetologicka ambulance
Prague, Praha 4, 14900
ResTrial s.r.o.
Prague, Praha 8, 18100
Milan Kvapil s.r.o., Diabetologicka ambulance Pribram
Příbram, Central Bohemia, 26201
Argentina11 sites
Mautalen Salud e Investigación
Buenos Aires, Buenos Aires F.D., C1128AAF
CONEXA Investigacion Clinica S.A.
Buenos Aires, 1012
CEMEDIAB
C.a.b.a., Ciudad Aut, C1205AAO
Instituto Centenario
CABA, Ciudad Autónoma de Buenos Aire, 1204
Centro Diabetológico Dr. Waitman
Córdoba, 5000
Clínica Universitaria Reina Fabiola
Córdoba, X50004FHP
Instituto de Investigaciones Clinicas Rosario
Rosario, Santa Fe Province, 2000
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario, Santa Fe Province, 2000
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, T4000AXL
Centro de Diagnóstico y Rehabilitación (CEDIR)
Santa Fe, 3000
Sanatorio San Martin
Venado Tuerto, Santa Fe Province, 2600
Australia11 sites
Emeritus Research
Botany, New South Wales, 2019
Box Hill Hospital
Box Hill, Victoria, 3128
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Core Research Group
Brisbane, Queensland, 4064
Emeritus Research
Camberwell, Victoria, 3124
Austin Health - Repatriation Hospital
Heidelberg West, Victoria, 3081
Advara HeartCare Joondalup
Joondalup, Western Australia, 6027
Logan Hospital
Meadowbrook, Queensland, 4131
Baker IDI Heart and Diabetes Institute - Melbourne
Melbourne, Victoria, 3004
The AIM Centre / Hunter Diabetes Centre
Merewether, New South Wales, 2291
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, South Australia, 5046
India9 sites
Medstar Speciality Hospital
Bangalore, Karnataka, 560092
Karnataka Institute of Medical Sciences
Hubli, Karnataka, 580021
Kumudini Devi Diabetes Research Center
Hyderabad, Telangana, 500082
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, 452010
Arthur Asirvatham Hospital
Madurai, Tamil Nadu, 625020
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
Mumbai, Maharashtra, 400008
BSES MG Hospital
Mumbai, Maharashtra, 400058
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, Maharashtra, 441108
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004
Brazil8 sites
Centro de Pesquisa Clinica do Brasil
Brasília, Federal District, 71625-175
Instituto de Pesquisa clinica de Campinas
Campinas, São Paulo, 13060-080
Cendi - Endocrinologia e Diabetes
Goiânia, Goiás, 74230-035
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, São Paulo, 17504-072
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, Rio Grande do Sul, 99010-120
Pesquisare Saude
Santo André, São Paulo, 09080-110
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010
Instituto Lóbus
Volta Redonda, Rio de Janeiro, 27253-003
Greece7 sites
Athens Medical Center
Athens, Attikí, 151 25
University General Hospital of Larissa
Larissa, Thessalía, 41110
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía, 54642
Euromedica General Clinic of Thessaloniki
Thessaloniki, Thessaloníki, 546 45
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, 564 29
Thermi Clinic
Thessaloniki, Thessaloníki, 570 01
424 Military General Training Hospital
Thessaloniki, 564 29
South Korea6 sites
Yeungnam Univeristy Medical Center
Gyeongsan-si, Kyǒngsangbuk-do, 42415
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620
Korea University Anam Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 02841
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 06591
Kyung Hee University Hospital at Gangdong
Seoul, Seoul-teukbyeolsi [Seoul], 134-090
Yonsei University-Wonju Severance Christian Hospital
Wŏnju, Kang-won-do, 26426
Puerto Rico2 sites
Advanced Clinical Research, LLC
Bayamón, PR, 00959
Isis Clinical Research Center
Guaynabo, PR, 00968
About this study
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)
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.
- Conditions
- Obesity, Overweight, Type 2 Diabetes
- Being tested
- Orforglipron, Placebo
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrforglipronDrug
Also called LY3502970
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received matching placebo capsule orally once daily (QD). Treatment was initiated with placebo corresponding to 1 milligram (mg) equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required. Receives: Drug: Placebo |
| 6 mg Orforglipron QD | Experimental | Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required. Receives: Drug: Orforglipron |
| 12 mg Orforglipron QD | Experimental | Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required. Receives: Drug: Orforglipron |
| 36 mg Orforglipron QD | Experimental | Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required. Receives: Drug: Orforglipron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Body Weight
Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral antihyperglycemic medications (AHMs) classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Measured: Baseline, Week 72
Secondary outcomes (14)
Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline
Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Measured: Baseline to Week 72
Percentage of Participants Who Achieved ≥10% Body Weight Reduction From Baseline
Percentage of participants with ≥10% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Measured: Baseline to Week 72
Percentage of Participants Who Achieved ≥15% Body Weight Reduction From Baseline
Percentage of participants with ≥15% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Measured: Baseline to Week 72
Change From Baseline in Waist Circumference
Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Measured: Baseline, Week 72
Change From Baseline in Hemoglobin A1c (HbA1c) %
- Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time.
- Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Measured: Baseline, Week 72
Change From Baseline in Fasting Serum Glucose (FSG)
Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Measured: Baseline, Week 72
Percentage of Participants Who Achieved Hemoglobin A1c (HbA1c) Target Value (<6.5%)
Percentage of participants who achieved hemoglobin A1c (HbA1c<6.5%) was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Measured: Baseline to Week 72
Percentage of Participants Who Achieved Hemoglobin A1c (HbA1c) Target Value (<7.0%)
Percentage of participants who achieved hemoglobin A1c (HbA1c<7%) was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Measured: Baseline to Week 72
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Measured: Baseline, Week 72
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Measured: Baseline, Week 72
Percent Change From Baseline in Fasting Insulin
- Fasting Insulin is a test used to measure the amount of insulin in the body.
- Values represented under "Geometric Least Squares Mean" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure was unstructured.
Measured: Baseline, Week 72
Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
Values represented under "Geometric Least Squares Mean" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure was unstructured.
Measured: Baseline, Week 72
Percent Change From Baseline in Triglycerides (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
Values represented under "Geometric Least Square Mean" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure was unstructured.
Measured: Baseline, Week 72
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
The SF-36v2 acute form, (1-week recall version) assesses participants' health-related quality of life on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health "now," whereas the remaining domains assess functioning "in the past week." Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.
Measured: Baseline, Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start5 Jun 2023
- Primary completion8 Aug 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872620
- Sponsor's protocol ID
- 18560
- Other IDs
- J2A-MC-GZGQ, 2022-502837-24-00, U1111-1289-8799
- Acronym
- ATTAIN-2
- Status last verified
- Sep 2026
- First submitted
- 15 May 2023
- Last updated
- 4 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Horn DB, Shukla AP, Huang H, Twum E, Allen SE, Kis SG. Orforglipron for obesity treatment in older patients >/=65 years with or without type 2 diabetes: A post hoc subgroup analysis of the ATTAIN-1 and ATTAIN-2 trials. Obes Pillars. 2026 Jul 14;19:100301. doi: 10.1016/j.obpill.2026.100301. eCollection 2026 Sep.
PubMed 42577069Horn DB, Ryan DH, Kis SG, Alves B, Mu Y, Kim SG, Aberle J, Bain SC, Allen S, Sarker E, Wu Q, Stefanski A, Jouravskaya I; ATTAIN-2 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial. Lancet. 2026 Dec 20;406(10522):2927-2944. doi: 10.1016/S0140-6736(25)02165-8. Epub 2025 Nov 20.
PubMed 41275875