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ATTAIN-2: A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05872620
Collaborator
(none)
1,500
Enrollment
136
Locations
4
Arms
24.7
Anticipated Duration (Months)
11
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Jun 5, 2023
Anticipated Primary Completion Date :
Jun 27, 2025
Anticipated Study Completion Date :
Jun 27, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Orforglipron Dose 1

Participants will receive orforglipron administered orally.

Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970

    		•
    Experimental: Orforglipron Dose 2

    Participants will receive orforglipron administered orally.

    Drug: Orforglipron
    Administered orally
    Other Names:
  • LY3502970

    		•
    Experimental: Orforglipron Dose 3

    Participants will receive orforglipron administered orally.

    Drug: Orforglipron
    Administered orally
    Other Names:
  • LY3502970

    		•
    Placebo Comparator: Placebo

    Participants will receive placebo

    Drug: Placebo
    Administered orally

    Outcome Measures

    Primary Outcome Measures

    1. Mean Percent Change from Baseline in Body Weight [Baseline, Week 72]

    Secondary Outcome Measures

    1. Mean Change from Baseline in Waist Circumference [Baseline, Week 72]

    2. Mean Change from Baseline in Hemoglobin A1c (HbA1c) % [Baseline, Week 72]

    3. Mean Change from Baseline in Fasting Glucose [Baseline, Week 72]

    4. Mean Change from Baseline in Systolic Blood Pressure (SBP) [Baseline, Week 72]

    5. Mean Change from Baseline in Fasting Triglycerides [Baseline, Week 72]

    6. Mean Percent Change from Baseline in Fasting non-High-Density Lipoprotein (HDL) Cholesterol [Baseline, Week 72]

    7. Mean Percent Change from Baseline in Fasting Insulin [Baseline, Week 72]

    8. Mean Change from Baseline in Diastolic Blood Pressure (DBP) [Baseline, Week 72]

    9. Mean Change from Baseline in Short Form 36 Version 2 Health Survey Acute Form (SF-36v2) Domain Scores [Baseline, Week 72]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cahaba Research - Pelham Pelham Alabama United States 35124
    2 Novak Clinical Research - Tucson - North La Cholla Boulevard Tucson Arizona United States 85741
    3 Yuma Clinical Trials Yuma Arizona United States 85364
    4 AMCR Institute Escondido California United States 92025
    5 Velocity Clinical Research, Huntington Park Huntington Park California United States 90255
    6 Velocity Clinical Research, Westlake Los Angeles California United States 90057
    7 Catalina Research Institute, LLC Montclair California United States 91763
    8 University Clinical Investigators, Inc. Tustin California United States 92780
    9 Encore Medical Research Hollywood Florida United States 33021
    10 East Coast Institute for Research, LLC Jacksonville Florida United States 32216
    11 South Florida Clinical Research Institute Margate Florida United States 33063
    12 Suncoast Clinical Research, Inc. New Port Richey Florida United States 34652
    13 Balanced Life Health Care Solutions/SKYCRNG Lawrenceville Georgia United States 30046
    14 Endocrine Research Solutions, Inc. Roswell Georgia United States 30076
    15 North Georgia Clinical Research Woodstock Georgia United States 30189
    16 Pacific Diabetes & Endocrine Center Honolulu Hawaii United States 96813
    17 Solaris Clinical Research Meridian Idaho United States 83646
    18 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
    19 MedStar Good Samaritan Hospital Baltimore Maryland United States 21239
    20 Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan United States 48098
    21 StudyMetrix Research Saint Peters Missouri United States 63303
    22 Las Vegas Medical Research Las Vegas Nevada United States 89113
    23 IMA Clinical Research Albuquerque New Mexico United States 87109
    24 Albany Medical College, Division of Community Endocrinology Albany New York United States 12203
    25 Albany Stratton VA Medical Center Albany New York United States 12208
    26 NYC Research INC Long Island City New York United States 11106
    27 Accellacare - Raleigh Raleigh North Carolina United States 27609
    28 Summit Headlands Portland Oregon United States 97210
    29 Alliance for Multispecialty Research, LLC Knoxville Tennessee United States 37909
    30 Velocity Clinical Research, Dallas Dallas Texas United States 75230
    31 Soma Clinical Trials Denison Texas United States 75020
    32 Biopharma Informatic, LLC Houston Texas United States 77043
    33 Epic Medical Research Red Oak Texas United States 75154
    34 Diabetes and Glandular Disease Center San Antonio Texas United States 78229
    35 VIP Trials San Antonio Texas United States 78230
    36 Charlottesville Medical Research Charlottesville Virginia United States 22911
    37 Universal Research Group Tacoma Washington United States 98405
    38 CEMEDIAB C.a.b.a. Ciudad Aut Argentina C1205AAO
    39 Mautalen Salud e Investigación Buenos Aires Ciudad Autónoma De Buenos Aire Argentina C1128AAF
    40 Instituto Centenario Caba Ciudad Autónoma De Buenos Aire Argentina 1204
    41 Instituto de Investigaciones Clinicas Rosario Rosario Santa Fe Argentina 2000
    42 Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica Rosario Santa Fe Argentina 2000
    43 Sanatorio San Martin Venado Tuerto Santa Fe Argentina 2600
    44 Centro de Investigaciones Médicas Tucuman San Miguel De Tucumán Tucumán Argentina T4000AXL
    45 CONEXA Investigacion Clinica S.A. Buenos Aires Argentina 1012
    46 Centro Diabetológico Dr. Waitman Córdoba Argentina 5000
    47 Clínica Universitaria Reina Fabiola Córdoba Argentina X50004FHP
    48 Centro de Diagnóstico y Rehabilitación (CEDIR) Santa Fe Argentina 3000
    49 Emeritus Research Botany New South Wales Australia 2019
    50 The AIM Centre / Hunter Diabetes Centre Merewether New South Wales Australia 2291
    51 Royal Brisbane and Women's Hospital Brisbane Queensland Australia 4029
    52 Core Research Group Brisbane Queensland Australia 4064
    53 Logan Hospital Meadowbrook Queensland Australia 4131
    54 Southern Adelaide Diabetes & Endocrine Services Oaklands Park South Australia Australia 5046
    55 Box Hill Hospital Box Hill Victoria Australia 3128
    56 Emeritus Research Camberwell Victoria Australia 3124
    57 Austin Health - Repatriation Hospital Heidelberg West Victoria Australia 3081
    58 Baker Heart and Diabetes Institute Melbourne Victoria Australia 3004
    59 Advara HeartCare Joondalup Joondalup Western Au Australia 6027
    60 Centro de Pesquisa Clinica do Brasil Brasilia Distrito Federal Brazil 71625-175
    61 Cendi - Endocrinologia e Diabetes Goiânia Goiás Brazil 74230-035
    62 Instituto Lóbus Volta Redonda Rio De Janeiro Brazil 27253-003
    63 Instituto Méderi de Pesquisa e Saúde Passo Fundo Rio Grande Do Sul Brazil 99010-120
    64 Instituto de Pesquisa clinica de Campinas Campinas São Paulo Brazil 13060-080
    65 Centro de Pesquisa Clínica de Marília - CPCLIM Marília São Paulo Brazil 17504-072
    66 Pesquisare Saude Santo André São Paulo Brazil 09080-110
    67 CEPIC - Centro Paulista de Investigação Clínica São Paulo Brazil 04266-010
    68 Chinese PLA General Hospital Beijing Beijing China 100853
    69 Chongqing General Hospital Chongqing Chongqing China 400014
    70 Hainan General Hospital Haikou Hainan China 570311
    71 The Fourth Hospital of Harbin Medical University Harbin Heilongjiang China 150001
    72 The First Affiliated Hospital of Henan University of Science &Technology Luoyang Henan China 471003
    73 The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450014
    74 Nanjing First Hospital Nanjing Jiangsu China 210006
    75 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210011
    76 Nantong First People's Hospital Nantong Jiangsu China 226001
    77 Dalian Municipal Central Hospital Affiliated of Dalian Medical University Dalian Liaoning China 116033
    78 Jinan Central Hospital Jinan Shandong China 250013
    79 Tianjin Medical University General Hospital Tianjin Tianjin China 300052
    80 Tianjin Medical University Zhu Xianyi Memorial Hospital Tianjin Tianjin China
    81 The First People's Hospital of Yunnan Province Kunming Yunnan China 650034
    82 MUDr. Alena Vachova Ceske Budejovice Jihočeský Czechia 37011
    83 MUDr. Tomas Edelsberger Krnov Moravskosl Czechia 79401
    84 Dialine - Interni a diabetologicka ambulance Pilsen Plzeň-město Czechia 301 00
    85 Diabet2 s.r.o., diabetologicka a interni ambulance Praha Praha 1 Czechia 11000
    86 Milan Kvapil s.r.o., Diabetologicka ambulance Praha Praha 4 Czechia 14900
    87 ResTrial s.r.o. Praha Praha 8 Czechia 18100
    88 MUDr. Sabina Palova Jilove u Prahy Praha-západ Czechia 252 42
    89 Milan Kvapil s.r.o., Diabetologicka ambulance Pribram Pribram Středočeský Kraj Czechia 26201
    90 Endokrinologie MUDr. Rehorkova s.r.o. Hradec Kralove Czechia 500 12
    91 Diahelp s.r.o Pardubice Czechia 530 02
    92 MUDr. Jitka Zemanová - diabetologie a interna s.r.o. Plzen Czechia 326 00
    93 Nemocnice Cesky Krumlov, a.s. Český Krumlov Czechia 381 01
    94 CDG Studienambulanz Hartard München Bayern Germany 80809
    95 Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf Wallerfing Bayern Germany 94574
    96 Diabetes Zentrum Dr. Tews Gelnhausen Hessen Germany 63571
    97 Diabetologische Schwerpunktpraxis Marck Linn Pickel Pulheim Hessen Germany 35415
    98 InnoDiab Forschung Gmbh Essen Nordrhein-Westfalen Germany 45136
    99 Medizentrum Essen Borbeck Essen Nordrhein-Westfalen Germany 45355
    100 Universitaetsklinikum Koeln Köln Nordrhein-Westfalen Germany 50937
    101 Institut für Diabetesforschung GmbH Münster Münster Nordrhein- Germany 48145
    102 Gemeinschaftspraxis Dr. med. Ralf Denger und Dr. med. Thomas Pfitzner Friedrichsthal Saarland Germany 66299
    103 SMO.MD GmbH Magdeburg Sachsen-Anhalt Germany 39120
    104 AmBeNet GmbH Leipzig Sachsen Germany 04107
    105 Arztpraxis Christine Kosch Pirna Pirna Sachsen Germany 01796
    106 Universität zu Lübeck - Institut für Endokrinologie und Diabetes Lübeck Schleswig-Holstein Germany 23562
    107 RED-Institut GmbH Oldenburg Schleswig-Holstein Germany 23758
    108 Diabetes Zentrum Wilhelmsburg Hamburg Germany 21109
    109 Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels Hohenmölsen Germany 06679
    110 Athens Medical Center Athens Attikí Greece 151 25
    111 Hippokration University Hopsital Thessaloniki Kentrikí Makedonía Greece 54642
    112 Euromedica General Clinic of Thessaloniki Thessaloniki Thessaloníki Greece 546 45
    113 424 Military General Training Hospital Thessaloniki Thessaloníki Greece 564 29
    114 Papageorgiou General Hospital of Thessaloniki Thessaloniki Thessaloníki Greece 564 29
    115 Thermi Clinic Thessaloniki Thessaloníki Greece 570 01
    116 University General Hospital of Larissa Larissa Greece 41110
    117 Shree Krishna Hospital Karamsad Gujarat India 388325
    118 Medstar Speciality Hospital Bangalore Karnataka India 560092
    119 Karnataka Institute of Medical Sciences Hubli Karnataka India 580021
    120 TOTALL Diabetes Hormone Institute Indore Madhya Pradesh India 452010
    121 Government Medical College, Aurangabad Aurangabad Maharashtra India 431001
    122 Topiwala National Medical College & B. Y. L. Nair Charitable Hospital Mumbai Maharashtra India 400008
    123 BSES MG Hospital Mumbai Maharashtra India 400058
    124 All India Institute of Medical Sciences (AIIMS) - Nagpur Nagpur Maharashtra India 441108
    125 Sahyadri Super Speciality Hospital Pune Maharashtra India 411004
    126 Arthur Asirvatham Hospital Madurai Tamil Nadu India 625020
    127 Kumudini Devi Diabetes Research Center Hyderabad Telangana India 500072
    128 Fortis Hospital Noida Uttar Pradesh India 201301
    129 Wonju Severance Christian Hospital Wonju Kang-won-do Korea, Republic of 26426
    130 Seoul National University Bundang Hospital Seongnam Kyǒnggi-do Korea, Republic of 13620
    131 Yeungnam Univeristy Medical Center Gyeongsan-si Kyǒngsangbuk-do Korea, Republic of 42415
    132 Korea University Anam Hospital Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 02841
    133 Kyung Hee University Hospital at Gangdong Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 134-090
    134 The Catholic Univ. of Korea Seoul St. Mary's Hospital Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 6591
    135 Advanced Clinical Research, LLC Bayamón Puerto Rico 00960
    136 Private Practice - Dr. Paola Mansilla-Letelier Guaynabo Puerto Rico 00970

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05872620
    Other Study ID Numbers:
    • 18560
    • J2A-MC-GZGQ
    • 2022-502837-24-00
    • U1111-1289-8799
    First Posted:
    May 24, 2023
    Last Update Posted:
    May 24, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Obesity
    Diabetes Mellitus, Type 2
    Overweight

    Study Results

    No Results Posted as of May 24, 2023